Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Thank you

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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
George Washington University Medical CenterWashington, District of Columbia  20037
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Division of OncologyPalo Alto, California  94304
Rush Cancer InstituteChicago, Illinois  60612