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
18 Years
N/A
Both
Anemia, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
David J. Straus, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066316
NCT ID:
NCT00003341
Start Date:
December 1997
Completion Date:
Related Keywords:
- Anemia
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- 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
- stage III adult diffuse mixed cell lymphoma
- 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
- Anemia
- Neoplasms
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| George Washington University Medical Center | Washington, District of Columbia 20037 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Comprehensive Cancer Centers of the Desert | Palm Springs, California 92262 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Division of Oncology | Palo Alto, California 94304 |
| Rush Cancer Institute | Chicago, Illinois 60612 |
