Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

1. juli 2013 oppdatert av: Memorial Sloan Kettering Cancer Center

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

275

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Støttende omsorg
Tildeling: Randomisert
Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: David J. Straus, MD, Memorial Sloan Kettering Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 1997

Primær fullføring (Faktiske)

1. september 2003

Studiet fullført (Faktiske)

1. september 2003

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

24. april 2003

Først lagt ut (Anslag)

25. april 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. juli 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2013

Sist bekreftet

1. juli 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

97-125
MSKCC-97125
ORTHO-PR-96-27-031
RPCI-DS-97-38
NCI-G98-1436

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .