Epoetin Alfa in Treating Anemia in Patients With Lymphoma... | NCT00003341 | Trialant
NCT00003341
Sponsor
Memorial Sloan Kettering Cancer Center
Status
Completed
Last Update Posted
Jul 3, 2013Estimated
Enrollment
275Estimated
Phase
Phase 3
Conditions
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
epoetin alfa
quality-of-life assessment
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00003341
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
97-125
Secondary IDs
ID
Type
Description
Link
MSKCC-97125
ORTHO-PR-96-27-031
RPCI-DS-97-38
NCI-G98-1436
Brief Title
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
Official Title
The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial
Acronym
Not provided
Organization
Memorial Sloan Kettering Cancer CenterOTHER
Status Module
Record Verification Date
Jul 2013
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
Dec 1997
Primary Completion Date
Sep 2003Actual
Completion Date
Sep 2003Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Apr 24, 2003
First Posted Date
Apr 25, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
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
Jul 1, 2013
Last Update Posted Date
Jul 3, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Memorial Sloan Kettering Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best time for giving epoetin alfa during chemotherapy is not yet known.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are receiving chemotherapy.
Detailed Description
OBJECTIVES:
Determine the hematologic response and transfusion requirements of patients with malignant lymphoma, chronic lymphocytic leukemia, or multiple myeloma with chemotherapy related moderate anemia treated with epoetin alfa.
Determine the effect of moderate anemia on quality of life of these patients treated with this regimen.
Correlate changes in quality of life with changes in anemia associated with treatment with epoetin alfa in these patients.
Determine the effect of changing quality of life on health care resource utilization among these patients treated with epoetin alfa.
OUTLINE: This is a randomized, open label, multicenter study.
Patients are evaluated for anemia during their prescribed chemotherapy regimens at either 3 or 4 week intervals beginning week 3 or 4. Patients with hemoglobin levels of 10.0-12.0 g/dL are randomized to 1 of 2 treatment arms. Patients with hemoglobin levels greater than 12.0 g/dL are not randomized until their hemoglobin levels decrease to 12.0 g/dL or below.
Arm I: Patients immediately receive epoetin alfa subcutaneously each week.
Arm II: Patients are observed for 6-8 weeks and then hemoglobin levels are reevaluated. Patients whose hemoglobin levels decrease below 9.0 g/dL receive epoetin alfa subcutaneously each week. Patients whose hemoglobin levels are at least 9.0 g/dL are observed for another 3-4 weeks and then hemoglobin levels are reevaluated.
Patients receive epoetin alfa treatment for up to 15 or 16 weeks.
Qualify of life questionnaires are completed every 3 or 4 weeks until week 30 or 32.
Patients are followed through week 36.
PROJECTED ACCRUAL: A total of 275 patients (at least 130 per treatment arm) will be accrued for this study.
Conditions Module
Conditions
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
Waldenström macroglobulinemia
stage II multiple myeloma
stage III multiple myeloma
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
Low grade, intermediate grade, or high grade (diffuse large cell immunoblastic only) NHL OR
Histologically confirmed Hodgkin's disease with prior chemotherapy
Evaluable lesion
Must be scheduled for at least 1 myelosuppressive cytotoxic regimen (experimental chemotherapy regimens allowed) for at least 4-6 months
No anemia predominantly due to factors other than cancer or chemotherapy (i.e.,iron or folate deficiencies, hemolysis, or gastrointestinal bleeding) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 70-100%
Life expectancy:
At least 6 months
Hematopoietic:
Transferrin saturation at least 20%
Ferritin at least 50 ng/mL OR
Adequate iron stores in bone marrow
If transferrin saturation is less than 20% or ferritin is less than 50 ng/mL, investigator may utilize bone marrow evaluation results to determine whether iron stores are adequate
Hemoglobin at least 10.0 g/dL
Hepatic:
Not specified
Renal:
Not specified
Cardiovascular:
No uncontrolled hypertension
Other:
HIV negative
No active, unresolved infection
No hypersensitivity to mammalian cell derived products
Must be able to read and understand English at a 6th grade level consistent with comprehending the quality of life questionnaires
No other malignancy within past 5 years, except basal cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent epoetin alfa independent of protocol
No concurrent interferons and interleukins (occasional short term use may be permitted on a case by case basis)
No prior peripheral blood stem cell transplantation
Chemotherapy:
See Disease Characteristics
At least 2 weeks since prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy
Surgery:
Not specified
Other:
At least 30 days since prior nonchemotherapy experimental agents
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
David J. Straus, MD
Memorial Sloan Kettering Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alta Bates Comprehensive Cancer Center
Berkeley
California
94704
United States
USC/Norris Comprehensive Cancer Center and Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
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
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
anemia
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Los Angeles
California
90033-0804
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
90095-1781
United States
Comprehensive Cancer Centers of the Desert
Palm Springs
California
92262
United States
Division of Oncology
Palo Alto
California
94304
United States
George Washington University Medical Center
Washington D.C.
District of Columbia
20037
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
33612-9497
United States
Rush Cancer Institute
Chicago
Illinois
60612
United States
University of Chicago Cancer Research Center
Chicago
Illinois
60637-1470
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland