Bendamustine Hydrochloride and Rituximab With or Without... | NCT01216683 | Trialant
NCT01216683
Sponsor
ECOG-ACRIN Cancer Research Group
Status
Completed
Last Update Posted
Jun 29, 2023Actual
Enrollment
289Actual
Phase
Phase 2
Conditions
Lymphoma
Interventions
rituximab
Bendamustin
bortezomib
lenalidomide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01216683
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E2408
Secondary IDs
ID
Type
Description
Link
E2408
Other Identifier
ECOG-ACRIN
NCI-2011-02644
Other Identifier
NCI
CDR0000683312
Other Identifier
NCI
Brief Title
Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
Official Title
A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma
Acronym
Not provided
Organization
Eastern Cooperative Oncology GroupNETWORK
Status Module
Record Verification Date
Jun 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 9, 2011Actual
Primary Completion Date
Dec 2, 2019Actual
Completion Date
Dec 2, 2019Actual
First Submitted Date
Oct 6, 2010
First Submission Date that Met QC Criteria
Oct 6, 2010
First Posted Date
Oct 7, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2020
Results First Submitted that Met QC Criteria
Feb 2, 2021
Results First Posted Date
Feb 23, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 14, 2023
Last Update Posted Date
Jun 29, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ECOG-ACRIN Cancer Research GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma.
PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
Detailed Description
OBJECTIVES:
Primary
To compare the complete remission rate in patients with high-risk follicular lymphoma receiving induction therapy comprising bendamustine hydrochloride and rituximab with vs without bortezomib.
To compare the 1-year post-induction disease-free survival rate in patients receiving continuation therapy comprising rituximab with vs without lenalidomide.
Secondary
To determine the 3-year progression-free survival and the 5-year overall survival of these patients.
To evaluate patient-reported outcomes at baseline and during treatment to determine differences in symptom palliation, treatment-related symptoms, and overall health-related quality of life.
To examine the association between baseline Follicular Lymphoma International Prognostic Index (FLIPI) information and outcome of these patients.
To examine the association between baseline and end-of-treatment patient comorbidities assessed by the Cumulative Illness Rating Scale (CIRS) and outcome.
To create an image and tissue bank including serial PET/CT scans, diagnostic paraffin-embedded tissue, germline DNA, and serial blood and bone marrow samples sufficient to support proposed and future studies of tumor and host characteristics that may predict for clinical outcome, including treatment arm effects, and enhance existing prognostic indices. (exploratory)
To evaluate the rate of peripheral neuropathy associated with subcutaneous and intravenous bortezomib.
OUTLINE: Patients are stratified according to FLIPI-1score (0-2 vs 3 vs 4-5) and Groupe d'Etude des Lymphomes Folliculaires (GELF) tumor burden (low vs high). Patients are randomized to 1 of 3 treatment arms.
Arm A then Arm D
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Arm B then Arm E
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Arm C then Arm F
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life (including fatigue, neurotoxicity, anxiety, and depression) is assessed by questionnaire at baseline and periodically during study therapy.
Blood, bone marrow, and tissue samples may be collected periodically for correlative studies and for a repository.
After completion of study therapy, patients are followed up periodically for 15 years.
Conditions Module
Conditions
Lymphoma
Keywords
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
289Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)
Experimental
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Drug: Bendamustin
Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)
Experimental
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Biological: rituximab
Drug: Bendamustin
Drug: bortezomib
Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)
Experimental
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rituximab
Biological
Given IV
Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)
Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.
Assessed at 1 year post-induction, approximately 1.5 years
Secondary Outcomes
Measure
Description
Time Frame
3-year Progression-free Survival Rate
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier.
Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria (Induction):
Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology
Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology
Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months
Bone marrow biopsy alone not acceptable
Stage II, III, or IV AND grade 1, 2, or 3a disease
Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:
Patient must meet ≥ 1 of the following GELF criteria:
Nodal or extranodal mass ≥ 7 cm
At least 3 nodal masses > 3.0 cm in diameter
Systemic symptoms due to lymphoma or B symptoms
Splenomegaly with spleen > 16 cm by CT scan
Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular cells)
Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10 g/dL, and/or platelets < 100 x 10^9/L)
Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):
Age ≥ 60 years
Stage III-IV disease
Hemoglobin level < 12 g/dL
> 4 nodal areas
Serum lactate dehydrogenase (LDH) level above normal
At least 1 objective measurable disease parameter
Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of randomization
Measurable disease in the liver is required if the liver is the only site of lymphoma
HIV-positive patients must meet all of the following criteria:
HIV is sensitive to antiretroviral therapy
Must be willing to take effective antiretroviral therapy if indicated
No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis
No history of AIDS-defining conditions
If on antiretroviral therapy, must not be taking zidovudine or stavudine
Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and ≥ 2 months following completion of study therapy or until the CD4 cells recover to over 250 cells/mm³
ECOG performance status 0-2
Absolute neutrophil count (ANC) ≥ 1,500/mm³ (includes neutrophils and bands)
Platelet count ≥ 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 5 x upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 x ULN
Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the study PI)
Negative pregnancy test
Fertile patients must use 2 effective methods (1 highly effective and 1 additional effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after completing study treatment
Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist® (for patients randomized to arm C and proceed onto arm F)
Exclusion Criteria (Induction):
Prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy
A prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
Recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years
Pregnant or nursing
Active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
≥ grade 2 neuropathy
Myocardial infarction within the past 6 months
NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Known hypersensitivity to boron or mannitol
Chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)
Inclusion Criteria (Continuation):
Patient must have improved their response or have had no interval change in their tumor measurements with restaging from Induction cycle 3 to 6 as determined at Cycle 6 restaging.
Adequate organ function
ECOG performance status 0-2
Patients with a prior history of HBV infection, but immune, with only IgG hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis (e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout induction and continuation therapy and for ≥ 12 months after the last rituximab dose
Additional requirements for Arm C induction patients registering to arm F:
Patients must be willing to take deep vein thrombosis (DVT) prophylaxis. Subjects with a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. Subjects without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis. Subjects who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen.
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenalidomide: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation/stopping lenalidomide. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
Patient must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment.
All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during the cycles of continuation therapy of which lenalidomide are taken and for at least 28 days after discontinuation/stopping lenalidomide. Patient must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment.
Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
Exclusion Criteria (Continuation):
Active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
≥ grade 2 neuropathy
Additional requirements for Arm C induction patients registering to arm F:
Evens AM, Hong F, Habermann TM, Advani RH, Gascoyne RD, Witzig TE, Quon A, Ranheim EA, Ansell SM, Cheema PS, Dy PA, O'Brien TE, Winter JN, Cescon TP, Chang JE, Kahl BS. A Three-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408. Clin Cancer Res. 2020 Sep 1;26(17):4468-4477. doi: 10.1158/1078-0432.CCR-20-1345. Epub 2020 Jun 12.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
This study was activated on December 13, 2010, accrued its first patient on February 9, 2011, and closed on May 13, 2015, with final accrual of 289 patients
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
Bendamustin: Given IV
Periods
Title
Milestones
Reasons Not Completed
Induction
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jun 15, 2016
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: rituximab
Drug: Bendamustin
Drug: lenalidomide
Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)
IDEC-C2B8
Chimeric anti-CD20 monoclonal antibody
Rituxan
Bendamustin
Drug
Given IV
Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)
Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)
Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)
Bendamustine hydrochloride
CEP-18083
TREANDA
bortezomib
Drug
Given IV
Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)
MLN341
LDP-341
Velcade®
PS-341
lenalidomide
Drug
Given orally
Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)
IMiD compound CC-5013
Revlimid®
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 222 evaluable patients. The proportion of patients with complete remission was compared between patients with Follicular Lymphoma International Prognostic Index (FLIPI) of 3-5 and patients with FLIPI of 0-2/unknown.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
1-year Disease-free Survival (DFS) Rate
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
This analysis was conducted among 203 evaluable patients in the continuation treatment portion of the study. The 1-year post induction disease-free survival rate was compared between patients with FLIPI of 3-5 and patients with FLIPI of 0-2/unknown.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
Assessed at 1 year post-induction, approximately 1.5 years
Progression-free Survival
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients with complete remission was compared between patients with CIRS <10 and patients with CIRS >=10. Higher CIRS scores indicate higher severity with max score of 56 points.
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
1-year Disease-free Survival (DFS) Rate
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients disease-free and alive at 1 year post induction treatment was compared between patients with CIRS <10 and patients with CIRS >=10. Higher CIRS scores indicate higher severity with max score of 56 points.
Assessed at 1 year post-induction, approximately 1.5 years
3-year Progression-free Survival Rate
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier.
Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
The 3-year progression-free survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (<10 vs. >=10). Higher CIRS scores indicate higher severity with max score of 56 points.
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
The 5-year overall survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (<10 vs. >=10). Higher CIRS scores indicate higher severity with max score of 56 points.
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Proportion of Patients With Grade 3 or Higher Peripheral Neuropathy
Peripheral neuropathy was assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Proportion of patients with grade 3 or higher peripheral neuropathy was compared between patients with subcutaneous bortezomib and patients with intravenous bortezomib.
Assessed every cycle during treatment and for 30 days after discontinuation of treatment, up to 15 years
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
Assessed at baseline
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
FACT-G total score at cycle 3 is considered as mid-treatment score. If FACT-G total score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
Assessed at cycle 6, approximately 6 months
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
Assessed at baseline
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
FACT-Lym subscale score at cycle 3 is considered as mid-treatment score. If FACT-Lym subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
Assessed at cycle 6, approximately 6 months
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
Assessed at baseline
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
FACIT-Fatigue subscale score at cycle 3 is considered as mid-treatment score. If FACIT-Fatigue subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
Assessed at cycle 6, approximately 6 months
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
Assessed at baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
Assessed at cycle 3, approximately 3 months
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
Assessed at end of induction treatment (cycle 6), approximately 6 months
Salinas
California
93901
United States
Stanford University Hospitals and Clinics
Stanford
California
94305
United States
The Medical Center of Aurora
Aurora
Colorado
80012
United States
Boulder Community Hospital
Boulder
Colorado
80301
United States
Rocky Mountain Cancer Centers-Boulder
Boulder
Colorado
80304
United States
Penrose-Saint Francis Healthcare
Colorado Springs
Colorado
80907
United States
Porter Adventist Hospital
Denver
Colorado
80210
United States
Exempla Saint Joseph Hospital
Denver
Colorado
80218
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Colorado
80218
United States
Rocky Mountain Cancer Centers-Midtown
Denver
Colorado
80218
United States
Rocky Mountain Cancer Centers-Rose
Denver
Colorado
80220
United States
Rose Medical Center
Denver
Colorado
80220
United States
Colorado Cancer Research Program CCOP
Denver
Colorado
80224-2522
United States
Colorado Blood Cancer Institute
Denver
Colorado
80907
United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Veterans Adminstration New Jersey Health Care System
East Orange
New Jersey
07018-1095
United States
Hunterdon Medical Center
Flemington
New Jersey
08822
United States
Cancer Institute of New Jersey At Hamilton
Hamilton
New Jersey
08690
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08903
United States
UMDNJ - New Jersey Medical School
Newark
New Jersey
07103
United States
New York University Langone Medical Center
New York
New York
10016
United States
Essentia Health Cancer Center-South University Clinic
Fargo
North Dakota
58103
United States
Roger Maris Cancer Center
Fargo
North Dakota
58122
United States
Sanford Clinic North-Fargo
Fargo
North Dakota
58122
United States
Sanford Medical Center-Fargo
Fargo
North Dakota
58122
United States
Summa Akron City Hospital/Cooper Cancer Center
Akron
Ohio
44304
United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green
Ohio
43402
United States
Mercy Medical Center
Canton
Ohio
44708
United States
Geaugra Hospital
Chardon
Ohio
44024
United States
Case Western Reserve University
Cleveland
Ohio
44106
United States
MetroHealth Medical Center
Cleveland
Ohio
44109
United States
Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights
Ohio
44124
United States
Lake University Ireland Cancer Center
Mentor
Ohio
44060
United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights
Ohio
44130
United States
UHHS-Chagrin Highlands Medical Center
Orange
Ohio
44122
United States
Toledo Clinic Cancer Centers-Oregon
Oregon
Ohio
43616
United States
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky
Ohio
44870
United States
Flower Hospital
Sylvania
Ohio
43560
United States
Toledo Community Hospital Oncology Program CCOP
Toledo
Ohio
43617
United States
Toledo Clinic Cancer Centers-Toledo
Toledo
Ohio
43623
United States
University Hospitals Sharon Health Center
Wadsworth
Ohio
44281
United States
UH-Seidman Cancer Center at Saint John Medical Center
Westlake
Ohio
44145
United States
UHHS-Westlake Medical Center
Westlake
Ohio
44145
United States
Abington Memorial Hospital
Abington
Pennsylvania
19001
United States
Geisinger Medical Center
Danville
Pennsylvania
17822
United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Pennsylvania
18201
United States
Penn State Milton S Hershey Medical Center
Hershey
Pennsylvania
17033-0850
United States
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg
Pennsylvania
17837
United States
Lewistown Hospital
Lewistown
Pennsylvania
17044
United States
Pennsylvania Hospital
Philadelphia
Pennsylvania
19107
United States
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
19107
United States
Aria Health-Torresdale Campus
Philadelphia
Pennsylvania
19114
United States
Geisinger Medical Oncology-Pottsville
Pottsville
Pennsylvania
17901
United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton
Pennsylvania
18508
United States
Geisinger Medical Group
State College
Pennsylvania
16801
United States
Mount Nittany Medical Center
State College
Pennsylvania
16803
United States
Reading Hospital
West Reading
Pennsylvania
19611
United States
Geisinger Wyoming Valley
Wilkes-Barre
Pennsylvania
18711
United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls
South Dakota
57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls
South Dakota
57117-5134
United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin
Tennessee
37067
United States
Vanderbilt-Ingram Cancer Center
Nashville
Tennessee
37232
United States
Parkland Memorial Hospital
Dallas
Texas
75235
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
West Virginia University Charleston
Charleston
West Virginia
25304
United States
West Virginia University Healthcare
Morgantown
West Virginia
26506
United States
Langlade Hospital and Cancer Center
Antigo
Wisconsin
54409
United States
Fox Valley Hematology and Oncology
Appleton
Wisconsin
54911
United States
Marshfield Clinic-Chippewa Center
Chippewa Falls
Wisconsin
54729
United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire
Wisconsin
54701
United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay
Wisconsin
54301-3526
United States
Bellin Memorial Hospital
Green Bay
Wisconsin
54301
United States
Saint Vincent Hospital
Green Bay
Wisconsin
54301
United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay
Wisconsin
54303
United States
Saint Mary's Hospital
Green Bay
Wisconsin
54303
United States
Aurora BayCare Medical Center
Green Bay
Wisconsin
54311-6519
United States
UW Cancer Center Johnson Creek
Johnson Creek
Wisconsin
53038
United States
Gundersen Lutheran Medical Center
La Crosse
Wisconsin
54601
United States
Dean Hematology and Oncology Clinic
Madison
Wisconsin
53717
United States
University of Wisconsin Hospital and Clinics
Madison
Wisconsin
53792
United States
Vince Lombardi Cancer Clinic-Marinette
Marinette
Wisconsin
54143
United States
Marshfield Clinic
Marshfield
Wisconsin
54449
United States
Saint Joseph's Hospital
Marshfield
Wisconsin
54449
United States
Froedtert and the Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Marshfield Clinic-Minocqua Center
Minocqua
Wisconsin
54548
United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc
Wisconsin
53066-3896
United States
Green Bay Oncology - Oconto Falls
Oconto Falls
Wisconsin
54154
United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Wisconsin
54904
United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander
Wisconsin
54501
United States
Saint Mary's Hospital
Rhinelander
Wisconsin
54501
United States
Marshfield Clinic-Rice Lake Center
Rice Lake
Wisconsin
54868
United States
Saint Nicholas Hospital
Sheboygan
Wisconsin
53081
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Wisconsin
53081
United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point
Wisconsin
54481
United States
Saint Michael's Hospital
Stevens Point
Wisconsin
54481
United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay
Wisconsin
54235
United States
Aurora Medical Center in Summit
Summit
Wisconsin
53066
United States
Vince Lombardi Cancer Clinic
Two Rivers
Wisconsin
54241
United States
Waukesha Memorial Hospital - ProHealth Care
Waukesha
Wisconsin
53188
United States
Aspirus Regional Cancer Center
Wausau
Wisconsin
54401
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa
Wisconsin
53226
United States
Diagnostic and Treatment Center
Weston
Wisconsin
54476
United States
Marshfield Clinic - Weston Center
Weston
Wisconsin
54476
United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
Wisconsin
54494
United States
Riverview Hospital
Wisconsin Rapids
Wisconsin
54494
United States
FG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
rituximab: Given IV
Bendamustin: Given IV
bortezomib: Given IV
FG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
Bendamustin: Given IV
lenalidomide: Given orally
FG00065 subjects
FG00199 subjects
FG002125 subjects
Received Treatment and Assessed for Toxicities
FG00065 subjects
FG00193 subjects
FG002122 subjects
Eligible and Treated
FG00059 subjects
FG00185 subjects
FG002114 subjects
Included in the Primary Analysis of Complete Remission Rate During Induction Treatment
FG00048 subjects
FG00185 subjects
FG00289 subjects
COMPLETED
FG00061 subjects
FG00180 subjects
FG002104 subjects
NOT COMPLETED
FG0004 subjects
FG00119 subjects
FG00221 subjects
Type
Comment
Reasons
Never started treatment
FG0000 subjects
FG0016 subjects
FG0023 subjects
Lack of Efficacy
FG0004 subjects
FG0013 subjects
FG0027 subjects
Adverse Event
FG0000 subjects
FG0015 subjects
FG0025 subjects
Death
FG0000 subjects
FG0010 subjects
FG0022 subjects
Withdrawal by Subject
FG0000 subjects
FG0014 subjects
FG0022 subjects
Other disease
FG0000 subjects
FG0011 subjects
FG0022 subjects
Continuation
Type
Comment
Milestone Data
STARTED
FG00059 subjects
FG00171 subjects
FG00294 subjects
Received Continuation Treatment
FG00059 subjects
FG00170 subjects
FG00289 subjects
COMPLETED
FG00044 subjects
FG00156 subjects
FG00251 subjects
NOT COMPLETED
FG00015 subjects
FG00115 subjects
FG00243 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0027 subjects
Adverse Event
FG000
Eligible and treated patients are included in this analysis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
BG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
BG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00059
BG00185
BG002114
BG003258
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00059(36 to 79)
BG00160(24 to 86)
BG00261(24 to 88)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00026
BG00134
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).
This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
ID
Title
Description
OG000
Arm A and Arm C (Induction With Bendamustine + Rituximab)
Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
OG001
Arm B (Induction With Bendamustine + Rituximab + Bortezomib)
Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG000137
OG00185
Title
Denominators
Categories
Title
Measurements
OG0000.62(0.53 to 0.70)
OG0010.75(0.65 to 0.84)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.
All eligible and treated patients in the continuation phase of arm A + D and arm C + F.
The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed at 1 year post-induction, approximately 1.5 years
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Secondary
3-year Progression-free Survival Rate
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier.
Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
This analysis was conducted among 222 evaluable patients.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Secondary
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
This analysis was conducted among 222 evaluable patients.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 222 evaluable patients. The proportion of patients with complete remission was compared between patients with Follicular Lymphoma International Prognostic Index (FLIPI) of 3-5 and patients with FLIPI of 0-2/unknown.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
This analysis was conducted among 222 evaluable patients that were enrolled before activation of addendum #8. The proportion of patients with complete remission was compared between FLIPI 0-2/unknown and FLIPI 3-5 at baseline.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
ID
Title
Description
OG000
FLIPI 0-2/Unknown
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 0-2 or unknown.
OG001
FLIPI 3-5
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 3-5.
Secondary
1-year Disease-free Survival (DFS) Rate
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
This analysis was conducted among 203 evaluable patients in the continuation treatment portion of the study. The 1-year post induction disease-free survival rate was compared between patients with FLIPI of 3-5 and patients with FLIPI of 0-2/unknown.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
This analysis was conducted among 203 evaluable patients in the continuation treatment portion of the study. The 1-year post induction disease-free survival rate was compared between patients with FLIPI of 3-5 and patients with FLIPI of 0-2/unknown.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed at 1 year post-induction, approximately 1.5 years
ID
Title
Description
OG000
FLIPI 0-2/Unknown
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 0-2 or unknown.
OG001
FLIPI 3-5
Secondary
Progression-free Survival
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
This analysis was conducted among 222 evaluable patients that were enrolled before activation of addendum #8.
Posted
Median
95% Confidence Interval
years
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
FLIPI 0-2/Unknown
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 0-2 or unknown.
OG001
FLIPI 3-5
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 3-5.
Secondary
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age > 60 years, Ann Arbor stage III-IV, hemoglobin level < 12 gm/dL, >4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.
This analysis was conducted among 222 evaluable patients.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
FLIPI 0-2/Unknown
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 0-2 or unknown.
OG001
FLIPI 3-5
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 3-5.
Units
Counts
Secondary
Complete Remission (CR) Rate
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.
This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients with complete remission was compared between patients with CIRS <10 and patients with CIRS >=10. Higher CIRS scores indicate higher severity with max score of 56 points.
This analysis was conducted among 250 evaluable patients with baseline CIRS data available. The proportion of patients with complete remission was compared between baseline CIRS <10 and baseline CIRS >=10.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
ID
Title
Description
OG000
CIRS <10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score <10
OG001
CIRS >=10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10
Units
Counts
Participants
Secondary
1-year Disease-free Survival (DFS) Rate
1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion.
This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients disease-free and alive at 1 year post induction treatment was compared between patients with CIRS <10 and patients with CIRS >=10. Higher CIRS scores indicate higher severity with max score of 56 points.
This analysis was conducted among 250 evaluable patients with baseline Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients disease-free and alive at 1 year post induction treatment was compared between patients with CIRS <10 and patients with CIRS >=10.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed at 1 year post-induction, approximately 1.5 years
ID
Title
Description
OG000
CIRS <10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score <10
OG001
CIRS >=10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10.
Secondary
3-year Progression-free Survival Rate
Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier.
Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, >=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
The 3-year progression-free survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (<10 vs. >=10). Higher CIRS scores indicate higher severity with max score of 56 points.
This analysis was conducted among 250 evaluable patients with baseline Cumulative Illness Rating Scale (CIRS) data available.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
CIRS <10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score <10
OG001
CIRS >=10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10
Secondary
5-year Overall Survival Rate
Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.
The 5-year overall survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (<10 vs. >=10). Higher CIRS scores indicate higher severity with max score of 56 points.
This analysis was conducted among 250 evaluable patients with baseline Cumulative Illness Rating Scale (CIRS) data available.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
ID
Title
Description
OG000
CIRS <10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score <10
OG001
CIRS >=10
Patients with baseline Cumulative Illness Rating Scale (CIRS) score >=10
Units
Counts
Participants
Secondary
Proportion of Patients With Grade 3 or Higher Peripheral Neuropathy
Peripheral neuropathy was assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Proportion of patients with grade 3 or higher peripheral neuropathy was compared between patients with subcutaneous bortezomib and patients with intravenous bortezomib.
This analysis was conducted among 99 patients who received bortezomib.
Posted
Number
95% Confidence Interval
proportion of participants
Assessed every cycle during treatment and for 30 days after discontinuation of treatment, up to 15 years
ID
Title
Description
OG000
Subcutaneous Bortezomib
Patients who received subcutaneous bortezomib.
OG001
Intravenous Bortezomib
Patients who received intravenous bortezomib. Patients who received both subcutaneous and intravenous bortezomib are included in the intravenous bortezomib group.
Units
Counts
Participants
OG000
Secondary
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
All enrolled patients with baseline FACT-G total score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at baseline
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
FACT-G total score at cycle 3 is considered as mid-treatment score. If FACT-G total score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
All enrolled patients with cycle 3 or cycle 4 FACT-G total score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Secondary
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.
All enrolled patients with cycle 6 FACT-G total score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 6, approximately 6 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
All enrolled patients with baseline FACT-Lym subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at baseline
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
FACT-Lym subscale score at cycle 3 is considered as mid-treatment score. If FACT-Lym subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
All enrolled patients with cycle 3 or cycle 4 FACT-Lym subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Secondary
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment
The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.
All enrolled patients with cycle 6 FACT-Lym subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 6, approximately 6 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
All enrolled patients with baseline FACIT-Fatigue subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at baseline
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
FACIT-Fatigue subscale score at cycle 3 is considered as mid-treatment score. If FACIT-Fatigue subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.
All enrolled patients with cycle 3 or cycle 4 FACIT-Fatigue subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Secondary
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.
All enrolled patients with cycle 6 FACIT-Fatigue subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 6, approximately 6 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
All enrolled patients with baseline FACT-GOG-NTX subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at baseline
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
All enrolled patients with cycle 3 FACT-GOG-NTX subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at cycle 3, approximately 3 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Secondary
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.
All enrolled patients with cycle 6 FACT-GOG-NTX subscale score available
Posted
Mean
Standard Deviation
score on a scale
Assessed at end of induction treatment (cycle 6), approximately 6 months
ID
Title
Description
OG000
Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
Time Frame
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
Description
Serious Adverse Events include post-baseline adverse events of grade 3 and higher that are definitely, probably or possibly related to protocol treatment based on the case report forms (CRFs).
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Deaths were counted in Step 1 (Arms A, B and C) for patients who did not registered to Step 2 continuation treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A
Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
2
65
51
65
64
65
EG001
Arm B
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
9
99
78
93
92
93
EG002
Arm C
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
12
125
96
122
122
122
EG003
Arm D
Arm D (continuation after Arm A): Beginning 4 weeks after the completion of Arm A induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
6
59
39
59
59
59
EG004
Arm E
Arm E (continuation after Arm B): Beginning 4 weeks after the completion of Arm B induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
7
71
44
70
70
70
EG005
Arm F
Arm F (continuation after Arm C): Immediately after completing Arm C induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Mistakenly stayed on treatment for longer than expected
FG0000 subjects
FG0011 subjects
FG0020 subjects
Not reported
FG0000 subjects
FG0010 subjects
FG0021 subjects
Never started treatment
FG0000 subjects
FG0011 subjects
FG0025 subjects
61
(24 to 88)
56
BG003116
Male
BG00033
BG00151
BG00258
BG003142
5
BG0039
Not Hispanic or Latino
BG00055
BG00182
BG002107
BG003244
Unknown or Not Reported
BG0002
BG0011
BG0022
BG0035
0
BG0031
Asian
BG0001
BG0013
BG0021
BG0035
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0004
BG0011
BG0026
BG00311
White
BG00053
BG00178
BG002102
BG003233
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0001
BG0012
BG0025
BG0038
OG001
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00053
OG00184
Title
Denominators
Categories
Title
Measurements
OG0000.85(0.72 to 0.93)
OG0010.67(0.56 to 0.77)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index
0.02
Superiority
OG001
Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00048
OG00185
OG00289
Title
Denominators
Categories
Title
Measurements
OG0000.77(0.65 to 0.90)
OG0010.82(0.74 to 0.91)
OG0020.76(0.67 to 0.85)
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00048
OG00185
OG00289
Title
Denominators
Categories
Title
Measurements
OG0000.87(0.79 to 0.97)
OG0010.86(0.77 to 0.94)
OG0020.83(0.75 to 0.91)
Units
Counts
Participants
OG000101
OG001121
Title
Denominators
Categories
Title
Measurements
OG0000.71(0.61 to 0.80)
OG0010.64(0.54 to 0.72)
Patients with baseline follicular lymphoma international prognostic index (FLIPI) score of 3-5.
Units
Counts
Participants
OG00091
OG001112
Title
Denominators
Categories
Title
Measurements
OG0000.84(0.74 to 0.90)
OG0010.74(0.65 to 0.82)
Units
Counts
Participants
OG000101
OG001121
Title
Denominators
Categories
Title
Measurements
OG0006.1(6.1 to NA)The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
OG0016.2(4.5 to NA)The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Participants
OG000101
OG001121
Title
Denominators
Categories
Title
Measurements
OG0000.90(0.84 to 0.96)
OG0010.81(0.74 to 0.89)
OG000207
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000.70(0.63 to 0.76)
OG0010.70(0.54 to 0.83)
Units
Counts
Participants
OG000207
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000.62(0.55 to 0.69)
OG0010.65(0.49 to 0.79)
Units
Counts
Participants
OG000207
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000.83(0.77 to 0.88)
OG0010.68(0.54 to 0.85)
OG000207
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000.87(0.83 to 0.92)
OG0010.80(0.69 to 0.94)
17
OG00182
Title
Denominators
Categories
Title
Measurements
OG0000.06(0.002 to 0.29)
OG0010.12(0.06 to 0.21)
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00063
OG00191
OG002119
Title
Denominators
Categories
Title
Measurements
OG00083.9± 14.2
OG00184.7± 15.5
OG00286.0± 16.0
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00055
OG00174
OG002107
Title
Denominators
Categories
Title
Measurements
OG00085.5± 15.7
OG00184.2± 16.4
OG00285.2± 15.9
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00054
OG00171
OG002101
Title
Denominators
Categories
Title
Measurements
OG00086.0± 17.7
OG00186.5± 13.9
OG00284.9± 18.2
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00063
OG00191
OG002120
Title
Denominators
Categories
Title
Measurements
OG00043.8± 8.7
OG00144.3± 9.3
OG00244.9± 10.6
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00055
OG00175
OG002108
Title
Denominators
Categories
Title
Measurements
OG00047.9± 7.4
OG00146.8± 8.7
OG00246.5± 9.5
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00054
OG00171
OG002101
Title
Denominators
Categories
Title
Measurements
OG00048.9± 7.5
OG00148.4± 8.5
OG00247.2± 9.9
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00063
OG00191
OG002120
Title
Denominators
Categories
Title
Measurements
OG00038.6± 10.5
OG00137.9± 11.4
OG00238.1± 12.1
Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00055
OG00175
OG002108
Title
Denominators
Categories
Title
Measurements
OG00039.2± 9.0
OG00134.5± 10.9
OG00236.3± 12.3
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00054
OG00171
OG002100
Title
Denominators
Categories
Title
Measurements
OG00039.9± 10.1
OG00139.1± 9.8
OG00236.3± 12.2
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00046
OG00165
OG00290
Title
Denominators
Categories
Title
Measurements
OG00039.9± 4.3
OG00138.7± 6.0
OG00238.8± 5.5
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00058
OG00180
OG002109
Title
Denominators
Categories
Title
Measurements
OG00040.0± 4.6
OG00138.6± 5.1
OG00239.1± 5.2
OG002
Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.