|
Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy Clinical research trials and Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy. Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy clinical trial. Participants frequently obtain the most expert healthcare available for their Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy  Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
For Condition: Lymphoma,Multiple Myeloma,Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the effect of moderate anemia on quality of life of these patients treated with this regimen. III. Correlate changes in quality of life with changes in anemia associated with treatment with epoetin alfa in these patients. IV. Determine the effect of changing quality of life on health care resource utilization among these patients treated with epoetin alfa. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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.] --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidStraus, Study Chair, Memorial Sloan-Kettering Cancer Center
Rush Cancer Institute
Chicago, Illinois, 60612
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Division of Oncology
Palo Alto, California, 94304
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
Additional Information:
Study ID Numbers: CDR0000066316; MSKCC-97125,NCI-G98-1436,ORTHO-PR-96-27-031,RPCI-DS-97-38
Study Start Date: December 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003341
Other Leukemia Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
2. T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
3. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
4. Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation
Related Studies:
Other Leukemia Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
|
|
|
|
|
|
|
|
