Non Hodgkin Lymphoma Clinical Trial
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
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.
Full 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.
Eligibility Criteria
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
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There are 18 Locations for this study
Berkeley California, 94704, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Palm Springs California, 92262, United States
Palo Alto California, 94304, United States
Washington District of Columbia, 20037, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Hershey Pennsylvania, 17033, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
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