Treatment and Natural History Study of Lymphomatoid Granu... | NCT00001379 | Trialant
NCT00001379
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Jun 19, 2025Actual
Enrollment
94Actual
Phase
Phase 2
Conditions
Lymphomatoid Granulomatosis
Granulomatosis, Lymphomatoid
Non-Hodgkins Lymphoma
Lymphoproliferative Disorder
Interventions
Interferon
Rituxan and EPOCH
Tumor biopsy
Bone marrow biopsy
Bone marrow aspirate
Lumber puncture
CT
Brain MRI
Echocardiogram
FDG-PET
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00001379
Obsolete or Duplicate NCT IDs
NCT00018993
Organization Study
940074
Secondary IDs
ID
Type
Description
Link
94-C-0074
Brief Title
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Official Title
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Acronym
Not provided
Organization
National Institutes of Health Clinical Center (CC)NIH
Status Module
Record Verification Date
Jun 2025
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
May 5, 1995Actual
Primary Completion Date
Jan 17, 2025Actual
Completion Date
Jan 17, 2025Actual
First Submitted Date
Nov 3, 1999
First Submission Date that Met QC Criteria
Nov 3, 1999
First Posted Date
Nov 4, 1999Estimated
Results Waived
Not provided
Results First Submitted Date
May 19, 2025
Results First Submitted that Met QC Criteria
Jun 9, 2025
Results First Posted Date
Jun 19, 2025Actual
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 9, 2025
Last Update Posted Date
Jun 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Christopher Melani, MD, Principal Investigator, National Cancer Institute (NCI)Principal Investigator
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
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
This study will evaluate the response and long-term effects of alpha-interferon in patients with lymphomatoid granulomatosis (LYG). The disease causes proliferation of destructive cells involving the lungs, skin, kidneys, and central nervous system.
Patients ages 12 and older who have LYG and who are not pregnant, or breast feeding may be eligible for this study. Alpha interferon or chemotherapy, or both, will be used. Alpha interferon is a protein the body naturally produces. If patients have grade 3 disease, they will usually receive etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)-rituximab (EPOCH-R) chemotherapy (each letter representing a drug). If patients have grade 1 or 2 disease, they will usually receive alpha interferon. If patients have LYG after receiving alpha interferon and/or EPOCH-R, they may receive rituximab alone or with alpha interferon. Rituximab is an antibody, binding to a specific molecule cluster of differentiation 20 (CD20) present on most B-cell lymphomas. Doses of several drugs in EPOCH-R may be increased if patients tolerated them in the previous cycle. If patients respond to EPOCH-R but still have low grade LYG, they may receive alpha interferon. Researchers will also try to obtain a biopsy of patient's lesions, to help in understanding the disease.
Patients self-administer alpha interferon by injection under the skin three times weekly. They will visit the clinic every 2 to 12 weeks for follow-up. Patients will receive alpha interferon for 1 year after LYG goes away, depending on response. EPOCH-R has these drugs: rituximab by vein on Day 1; prednisone by mouth on Days 1 to 5; etoposide, doxorubicin, and vincristine as a continuous intravenous infusion on Days 1 to 5; and cyclophosphamide by intravenous injection over 1 hour on Day 5. Each cycle lasts 3 weeks: 5 days of chemotherapy and 16 days of no chemotherapy. Etoposide, doxorubicin, and vincristine are infused through a small pump worn by patients. The drugs are given over 5 days through a central intravenous catheter. There are two cycles of EPOCH-R beyond a maximum response, with six cycles maximum. To reduce harm to bone marrow, patients receive granulocyte colony stimulating factor (G-CSF), self-administered by injection under the skin daily for approximately 10 days between chemotherapy cycles. If at the end of therapy, patients have a complete response, treatment will stop. If there is residual low-grade disease, patients may receive alpha interferon. Alpha interferon can have flu-like side effects of headache, fever, chills, and body aches. EPOCH-R drugs can cause gastrointestinal problems, hair loss, and weakness. Granulocyte colony-stimulating factor (G-CSF) can cause bone pain, body aches, and hair thinning. Chemotherapy can cause some patients to develop leukemia.
This study may or may not have a direct benefit for participants. It is not certain whether the new therapy will help decrease tumors. However, knowledge gained may improve the understanding of and treatment for LYG.
...
Detailed Description
BACKGROUND:
Lymphomatoid granulomatosis (LYG) is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs, skin, kidneys, and central nervous system.
It is divided into three grades, depending on the degree of necrosis and cellular atypia. The grades of disease are histologically based and do not necessarily correlate with clinical outcome. However, like other Epstein-Barr virus (EBV) related lymphoproliferative disorders (LPD's), LYG can transform into an aggressive large B-cell lymphoma, which would be included within the grade 3 category. It is important to note that not all grade 3 lesions are a large B-cell lymphoma.
Current evidence shows that LYG is a disease of B cells.
OBJECTIVES:
To determine the response and long-term efficacy of alpha-Interferon in patients with lymphomatoid granulomatosis (LYG).
To determine the response and long-term efficacy of dose-adjusted (DA)-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin rituximab (EPOCH-R) chemotherapy in patients with grade 3 LYG or in patients who have failed interferon.
ELIGIBILITY:
Patients must have a tissue diagnosis of grade 1, 2 and/or 3 LYG (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI).
Patients with any stage of disease will be eligible.
Previously untreated and treated patients are eligible.
Patients aged 12 or older will be eligible.
DESIGN:
Interferon is used as initial treatment in patients with grades 1 and 2 LYG. Patients will receive interferon for one year past complete remission (CR).
Patients who progress after or during interferon, and patients with grade 3 LYG will receive aggressive combination chemotherapy with DA-EPOCH-R (rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone).
Patients who fail one treatment approach may be crossed over to the other.
A total of 105 patients will be enrolled at this single institution.
Conditions Module
Conditions
Lymphomatoid Granulomatosis
Granulomatosis, Lymphomatoid
Non-Hodgkins Lymphoma
Lymphoproliferative Disorder
Keywords
Epstein-Barr Virus
Lymphoproliferative Disorder
Viral
Immunosuppression
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
94Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1-Interferon
Experimental
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Patients continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Biological: Interferon
Procedure: Tumor biopsy
Procedure: Bone marrow biopsy
Biological: Bone marrow aspirate
Procedure: Lumber puncture
Diagnostic Test: CT
Diagnostic Test: Brain MRI
Diagnostic Test: Echocardiogram
Diagnostic Test: FDG-PET
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Experimental
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Participants who relapse or progress may crossover to receive interferon.
Drug: Rituxan and EPOCH
Procedure: Tumor biopsy
Procedure: Bone marrow biopsy
Biological: Bone marrow aspirate
Procedure: Lumber puncture
Diagnostic Test: CT
Diagnostic Test: Brain MRI
Diagnostic Test: Echocardiogram
Diagnostic Test: FDG-PET
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Interferon
Biological
For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Patients continue taking interferon for 1 year beyond complete remission (CR).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR)
Overall response rate will be classified as the following: complete remission (CR), partial remission (PR), disease progression or disease stabilization measured by the Response Criteria. CR is no evidence of active disease on restaging for at least 2 months duration. All lesions must have decreased by > 75%, be gallium or positron emission tomography (PET) negative (if obtained) and be stable for > 3 months without new lesions appearing. PR is 50% or greater decrease in the sum of the products of the diameters of all measurable lesions for at least one month. Disease progression is 25% or greater progression in the sum of the products of the diameter of any measurable lesion over one month or the appearance or any new lesion consistent with metastatic disease. Disease stabilization is no change in the sum of the products of the diameters of all measurable lesions over two months and no new lesions consistent with disease.
From study enrollment and throughout treatment, up to a maximum of 40 months for the 2 interferon groups and 8 months for the 2 EPOCH-R groups.
Progression Free Survival (PFS)
PFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm.
Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to a maximum of 27 years for the 2 interferon groups and 20 years for the 2 EPOCH-R groups.
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
OS is defined as the time from treatment start date until date of death or date last known alive. The median OS will be determined and reported along with a 95% confidence interval.
Assessed from date of study enrollment until time of death or last follow-up, whichever comes first, up to a maximum of 27 years.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA:
Patients must have a tissue-diagnosis of grade 1, 2 and/or 3 lymphomatoid granulomatosis (LYG) (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI). Final histopathologic classification and pathologic grade will be determined by Stephania Pittaluga, medical doctor (M.D.) or her designee.
Patients with any stage of disease will be eligible.
Previously untreated and treated patients are eligible.
Patients aged 12 or older will be eligible.
EXCLUSION CRITERIA:
Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive. etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (DA-EPOCH-R) chemotherapy.
Patients with significant renal (serum creatinine (Cr.) greater than 1.5 mg/dl or creatinine clearance less than 40 cc/min) or hepatic (bilirubin greater than 2.5 x upper limit of normal (ULN) dysfunction not due to tumor involvement will not be eligible to receive DA-EPOCH-R chemotherapy.
Informed consent must be obtained.
Patients who in the opinion of the principal investigator are poor psychiatric or medical risk are not eligible.
Patients who received > 450 mg/m^2 doxorubicin and have a cardiac ejection fraction on echocardiogram less than or equal to 40% on protocol entry are not eligible to received DA-EPOCH-R.
Patients with prior hepatitis B exposure may be included in the study provided that they have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels below the World Health Organizations cutoff of 100 IU/mL prior to starting therapy.
Melani C, Dowdell K, Pittaluga S, Dunleavy K, Roschewski M, Song JY, Calattini S, Kawada JI, Price DA, Chattopadhyay PK, Roederer M, Lucas AN, Steinberg SM, Jaffe ES, Cohen JI, Wilson WH. Interferon alfa-2b in patients with low-grade lymphomatoid granulomatosis and chemotherapy with DA-EPOCH-R in patients with high-grade lymphomatoid granulomatosis: an open-label, single-centre, phase 2 trial. Lancet Haematol. 2023 May;10(5):e346-e358. doi: 10.1016/S2352-3026(23)00029-7. Epub 2023 Mar 31.
All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame
Clinical data will be available during the study and indefinitely.
Access Criteria
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
Periods
Title
Milestones
Reasons Not Completed
Initial Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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
Jan 27, 2021
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
Non-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
Arm 1-Interferon
IFN
Rituxan and EPOCH
Drug
For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Tumor bx
Bone marrow biopsy
Procedure
Baseline.
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
BM biopsy
Bone marrow aspirate
Biological
Baseline.
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
BM aspirate
Lumber puncture
Procedure
Baseline.
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
LP
CT
Diagnostic Test
Arm 1: At baseline, then every 4 weeks until on stable dose of interferon or a maximum of 6 monthly scans, then every 3 months while receiving interferon, and following completion of interferon. In surveillance, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year and yearly thereafter for 2 years. Arm 2: At baseline, following cycle 4, and following cycle 6 of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). In surveillance, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year and yearly thereafter for 2 years.
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Computed tomography
Brain MRI
Diagnostic Test
Arm 1: At baseline, then every 4 weeks until on stable dose of interferon or a maximum of 6 monthly scans, then every 3 months while receiving interferon, and following completion of interferon. In surveillance, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year and yearly thereafter for 2 years (patients with central nervous system (CNS) disease only).
Arm 2: At baseline, following cycle 4, and following cycle 6 of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). In surveillance, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year and yearly thereafter for 2 years (patients with CNS disease only).
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Brain magnetic resonance imaging
Echocardiogram
Diagnostic Test
For participants receiving > 450 mg/m^2 doxorubicin.
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Echo
FDG-PET
Diagnostic Test
Arm 1: Baseline and following completion of interferon. Arm 2: Baseline and following completion of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R).
Arm 1-Interferon
Arm 2-Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab (EPOCH-R)
Fluorodeoxyglucose positron emission tomography
Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months.
FG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
FG002
Participants Enrolled But Not Treated
Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.
FG003
Participant Treated With Rituximab and Radiation Only
Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) therapy.
FG00060 subjects
FG00128 subjects
FG0025 subjects
FG0031 subjects
Participants Eligible for Cross-over to EPOCH-R
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Participants Eligible for Cross-over to Interferon
FG0000 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
Participants Did Not Cross Over to Interferon or EPOCH Therapy After Initial Treatment
FG00036 subjects
FG00118 subjects
FG0020 subjectsDid not receive initial therapy with interferon or EPOCH-R.
FG0030 subjectsDid not receive initial therapy with interferon or EPOCH-R.
COMPLETED
FG00029 subjects
FG00123 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00031 subjects
FG0015 subjects
FG0025 subjects
FG0031 subjects
Type
Comment
Reasons
Disease progression
FG00021 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
Complicating disease/intercurrent illness
FG0006 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Received alternative treatment
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Refused further treatment
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Did not receive protocol treatment
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0030 subjects
Received treatment with whole brain radiation therapy (WBRT) + Rituximab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Cross-Over After Initial Treatment
Type
Comment
Milestone Data
STARTED
FG00024 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
Participants Eligible for Cross-over Treated With EPOCH-R
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Participants Eligible for Cross-over Treated With Interferon
FG0000 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG00014 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00010 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Disease progression
FG0004 subjects
FG0012 subjects
FG0020 subjects
FG003
Baseline data collected for 5 participants who were enrolled and not treated are reported here.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
BG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
BG002
Participants Enrolled But Not Treated
Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.
BG003
Participant Treated With Rituximab and Radiation Only
Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) therapy.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00128
BG0025
BG0031
BG00494
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0001
BG0011
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046.6± 13.88
BG00147.42± 12.76
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00114
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00060
BG00128
BG002
Baseline Histologic Grade of Lymphomatoid Granulomatosis (LYG)
Grade 1 LYG is rare atypical lymphoid cells, Epstein Barr virus-encoded ribonucleic acid (EBER)(+) cells, typically <5 cells/high-power field (HPF), and focal to absent necrosis. Grade 2 LYG has a greater number of large atypical lymphoid cells, EBER+ cells between 5-20 and occasionally up to 50 cells/HPF, and often extensive necrosis. Grade 3 LYG has a greater number of large atypical lymphoid cells, EBER+ cells typically >50 and often >100 cells/HPF, and often extensive necrosis. Not applicable (NA) = These were not graded due to having an alternative diagnosis other than LYG.
Count of Participants
Participants
Title
Denominators
Categories
Grade 1
Title
Measurements
BG00022
BG001
Prior Therapy
Categories of therapy are not mutually exclusive.
Count of Participants
Participants
Title
Denominators
Categories
None
Title
Measurements
BG00016
BG00113
BG002
Disease Sites
Other = sinus/nasal cavity, prostate, eyelid/conjunctiva, muscle, pancreas, vertebrae, vocal cord, parotid gland, and stomach). Categories are not mutually exclusive.
Count of Participants
Participants
Title
Denominators
Categories
Lung
Title
Measurements
BG00060
BG00128
Elevated lactate hydrogenase (LDH)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG00031
BG00112
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance status 0 is normal activity, fully active, able to carry on all pre-disease performance without restriction. 1 is symptoms but ambulatory, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. 2 is in bed <50% of the time, ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours. 3 is in bed >50% of the time, capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 is 100% bedridden. Performance status 5 is dead.
Count of Participants
Participants
Title
Denominators
Categories
0-1
Title
Measurements
BG00047
BG001
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
Overall Response Rate (ORR)
Overall response rate will be classified as the following: complete remission (CR), partial remission (PR), disease progression or disease stabilization measured by the Response Criteria. CR is no evidence of active disease on restaging for at least 2 months duration. All lesions must have decreased by > 75%, be gallium or positron emission tomography (PET) negative (if obtained) and be stable for > 3 months without new lesions appearing. PR is 50% or greater decrease in the sum of the products of the diameters of all measurable lesions for at least one month. Disease progression is 25% or greater progression in the sum of the products of the diameter of any measurable lesion over one month or the appearance or any new lesion consistent with metastatic disease. Disease stabilization is no change in the sum of the products of the diameters of all measurable lesions over two months and no new lesions consistent with disease.
9/94 participants were not analyzed because 5 were enrolled and not treated,3 participants died prior to restaging scans, and 1 was treated with rituximab and radiation only.
Posted
Number
95% Confidence Interval
percentage of participants
From study enrollment and throughout treatment, up to a maximum of 40 months for the 2 interferon groups and 8 months for the 2 EPOCH-R groups.
ID
Title
Description
OG000
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
OG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
OG002
Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab
All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).
OG003
Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon
All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.
Units
Counts
Participants
OG00058
OG00127
OG00221
OG003
Title
Denominators
Categories
Complete Remission
Title
Measurements
OG00053.45(40.80 to 65.67)
OG00151.85(33.99 to 69.26)
OG00257.14(36.55 to 75.53)
Primary
Progression Free Survival (PFS)
PFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm.
6/94 participants were not analyzed because 5 were enrolled and not treated, and 1 was treated with rituximab and radiation only.
Posted
Median
95% Confidence Interval
years
Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to a maximum of 27 years for the 2 interferon groups and 20 years for the 2 EPOCH-R groups.
ID
Title
Description
OG000
Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
Secondary
Overall Survival (OS)
OS is defined as the time from treatment start date until date of death or date last known alive. The median OS will be determined and reported along with a 95% confidence interval.
6/94 participants were not analyzed because 5 were enrolled and not treated and 1 was treated with rituximab and radiation only.
Posted
Median
95% Confidence Interval
years
Assessed from date of study enrollment until time of death or last follow-up, whichever comes first, up to a maximum of 27 years.
ID
Title
Description
OG000
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
OG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
5 participants who were followed and not treated on study were followed for survival and mortality.
Posted
Count of Participants
Participants
Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months.
ID
Title
Description
OG000
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
Time Frame
All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months.
Description
All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
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
Participants Treated With Initial Interferon Therapy
Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).
29
60
21
60
57
60
EG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
15
28
20
28
28
28
EG002
Participants Enrolled But Not Treated
Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.
5 participants were followed and not treated on study were followed for survival and mortality.
1
5
0
5
0
5
EG003
Participant Treated With Rituximab and Radiation Only
Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide/prednisone/vincristine/cyclophosphamide/doxorubicin/rituximab therapy.
0
1
0
1
1
1
EG004
Participants Treated With Cross-over EPOCH-R
Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
14
24
15
24
24
24
EG005
Participants Treated With Cross-over Interferon
Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.
6
10
6
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ALT, SGPT (serum glutamic pyruvic transaminase)
Hepatobiliary disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected1 at risk
EG004
Adult Respiratory Distress Syndrome (ARDS)
Respiratory, thoracic and mediastinal disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
CNS cerebrovascular ischemia
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac Arrhythmia - Other (Specify, __): sinus bradycardia
Cardiac disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Coagulation - Other (Specify, __): HPS
Blood and lymphatic system disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Confusion
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Death not associated with CTCAE term::Death NOS
General disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Death not associated with CTCAE term::Disease progression NOS
General disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnea (shortness of breath)
Respiratory, thoracic and mediastinal disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Infections and infestations
CTC v2.0
Systematic Assessment
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
EG00018 events10 affected60 at risk
EG00134 events14 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
General disorders
CTC v2.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal - Other (Specify, __): Worsening GERD
Gastrointestinal disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
CTC v2.0
Systematic Assessment
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
EG0001 events1 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
CTC v2.0
Systematic Assessment
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Bronchus
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
CTC v2.0
Systematic Assessment
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Lung (pneumonia)
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
CTC v2.0
Systematic Assessment
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Urinary tract NOS
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection - Other (Specify, __): Thyroid
Infections and infestations
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
Infections and infestations
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Infections and infestations
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
Infections and infestations
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Infections and infestations
CTC v2.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with unknown ANC::Lung (pneumonia)
Infections and infestations
CTC v2.0
Systematic Assessment
EG0002 events2 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Infection with unknown ANC::Rectum
Infections and infestations
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Leukocytes (total WBC)
Blood and lymphatic system disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Neuropathy: motor
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophils/granulocytes (ANC/AGC)
Blood and lymphatic system disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0012 events2 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Pain::Bone
Musculoskeletal and connective tissue disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Pain::Chest wall
Musculoskeletal and connective tissue disorders
CTC v2.0
Systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Potassium, serum-low (hypokalemia)
Metabolism and nutrition disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Seizure
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0004 events3 affected60 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Somnolence/depressed level of consciousness
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Syncope (fainting)
Nervous system disorders
CTC v2.0
Systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Thrombosis/thrombus/embolism
Cardiac disorders
CTC v2.0
Systematic Assessment
EG0004 events4 affected60 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected5 at risk
EG003
Thrombotic microangiopathy
Cardiac disorders
CTC v2.0
Systematic Assessment
(e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS])
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
OG002
Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab
All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).
OG003
Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon
All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.
Units
Counts
Participants
OG00060
OG00128
OG00224
OG00310
Title
Denominators
Categories
Title
Measurements
OG0001.01(0.61 to 6.54)
OG0010.69(0.45 to 8.43)
OG0020.23(0.14 to 0.49)
OG0030.53(0.33 to NA)Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).
OG002
Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab
All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).
OG003
Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon
All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.
Units
Counts
Participants
OG00060
OG00128
OG00224
OG00310
Title
Denominators
Categories
Title
Measurements
OG00012.22(7.29 to NA)Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).
OG0019.84(3.35 to NA)Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).
OG0028.43(2.66 to NA)Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).
OG00312.13(2.89 to NA)Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).
OG001
Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response.
Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles.
Participants who relapse or progress may crossover to receive interferon.
OG002
Participants Enrolled But Not Treated
Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.
5 participants were followed and not treated on study were followed for survival and mortality.
OG003
Participant Treated With Rituximab and Radiation Only
Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide/prednisone/vincristine/cyclophosphamide/doxorubicin/rituximab therapy.
OG004
Participants Treated With Cross-over Interferon
Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.
OG005
Participants Treated With Cross-over EPOCH-R
Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).