- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003341
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Berkeley, California, United States, 94704
- Alta Bates Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Palm Springs, California, United States, 92262
- Comprehensive Cancer Centers of the Desert
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Palo Alto, California, United States, 94304
- Division of Oncology
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Medical Center
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60612
- Rush Cancer Institute
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia, or multiple myeloma
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David J. Straus, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- anemia
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- 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
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved 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
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- refractory multiple myeloma
- Waldenström macroglobulinemia
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage II adult Hodgkin lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Anemia
- Plasmacytoma
- Hematinics
- Epoetin Alfa
Other Study ID Numbers
- 97-125
- MSKCC-97125
- ORTHO-PR-96-27-031
- RPCI-DS-97-38
- NCI-G98-1436
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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