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Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003341
  Purpose

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.


Condition Intervention Phase
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Quality of Life
Drug: epoetin alfa
Procedure: quality-of-life assessment
Phase III

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Anemia    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   275
Study Start Date:   December 1997

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003341

Locations
United States, California
Alta Bates Comprehensive Cancer Center    
      Berkeley, California, United States, 94704
Comprehensive Cancer Centers of the Desert    
      Palm Springs, California, United States, 92262
Division of Oncology    
      Palo Alto, California, United States, 94304
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital    
      Los Angeles, California, United States, 90033-0804
United States, District of Columbia
George Washington University Medical Center    
      Washington, District of Columbia, United States, 20037
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute    
      Tampa, Florida, United States, 33612-9497
United States, Illinois
Rush Cancer Institute    
      Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland    
      Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center    
      Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Taussig Cancer Center    
      Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Milton S. Hershey Medical Center    
      Hershey, Pennsylvania, United States, 17033-0850
United States, Tennessee
Vanderbilt-Ingram Cancer Center    
      Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     David J. Straus, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066316, MSKCC-97125, ORTHO-PR-96-27-031, RPCI-DS-97-38, NCI-G98-1436
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003341
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
refractory plasma cell neoplasm  
Waldenstrom 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

Study placed in the following topic categories:
Epoetin Alfa
Leukemia, Lymphoid
Hodgkin's disease
Blood Protein Disorders
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Quality of Life
Paraproteinemias
Lymphoma, B-Cell, Marginal Zone
Hemostatic Disorders
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Blood Coagulation Disorders
Anemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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