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Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

3. desember 2013 oppdatert av: Amgen

Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the rate of complete response and partial response in patients with intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival, time to response, and time to disease progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to the number of risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60), tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1), performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond receive 2 more courses. Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as described above). Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alabama
      • Montgomery, Alabama, Forente stater, 36106
        • Montgomery Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Burbank, California, Forente stater, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Rancho Mirage, California, Forente stater, 92270
        • Cancer and Blood Institute of the Desert
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Southeast Florida Hematology-Oncology Group
      • Miami, Florida, Forente stater, 33176
        • Oncology-Hematology Group of South Florida
      • Miami Beach, Florida, Forente stater, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Pensacola, Florida, Forente stater, 32501
        • Hematology-Oncology Associates, PA
    • Kansas
      • Hutchinson, Kansas, Forente stater, 67502
        • Hutchinson Clinic, P.A.
    • Kentucky
      • Crestview Hills, Kentucky, Forente stater, 41017
        • Hematology/Oncology Care Inc.
    • Maine
      • Scarborough, Maine, Forente stater, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Associates in Oncology and Hematology
    • Massachusetts
      • Peabody, Massachusetts, Forente stater, 01960
        • North Shore Cancer Center
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeland Medical Center - St. Joseph
    • Missouri
      • Rolla, Missouri, Forente stater, 65401
        • Bond Clinic
      • Saint Louis, Missouri, Forente stater, 63136
        • Midwest Hematology Oncology Consultants, Ltd.
    • New Jersey
      • Morristown, New Jersey, Forente stater, 07962
        • Hematology Oncology Associates
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • New Mexico Oncology-Hematology
    • New York
      • Bronx, New York, Forente stater, 10466
        • Our Lady of Mercy Medical Center
      • Brooklyn, New York, Forente stater, 11235
        • HemOnCare, P.C.
    • North Carolina
      • Hickory, North Carolina, Forente stater, 28603
        • N.W. Carolina Oncology & Hematology, P.A.
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Oncology/Hematology Care, Inc.
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38163
        • University of Tennessee, Memphis
    • Utah
      • Salt Lake City, Utah, Forente stater, 84124
        • Intermountain Hematology/Oncology Associates, Inc.
    • Vermont
      • Colchester, Vermont, Forente stater, 05446
        • Vermont Center for Cancer Medicine, Inc.
    • Virginia
      • Richmond, Virginia, Forente stater, 23226
        • Hematology & Oncology Associates of Virginia

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 intermediate or high grade non-Hodgkin's lymphoma Stage II, III, or IV disease B-cell where lymphoid cells are CD20 or CD19 positive No mantle cell, lymphoblastic, or peripheral T-cell non-Hodgkin's lymphoma Measurable or evaluable disease No prior treatment for lymphoma No known CNS metastases 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 60-100% Life expectancy: At least 12 weeks Hematopoietic: Unless documented bone marrow disease: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of severe heart disease, cardiomyopathy, or congestive heart failure LVEF normal by MUGA or echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection as defined by: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, urinary tract infection) OR Fever with a clinical site of infection identified OR Microbiologically documented infection, including, but not limited to, bacteremia or septicemia No known HIV positivity No known sensitivity to E. coli derivatives (e.g., asparaginase, human insulin, human growth hormone, interferon alfa-2b) No other prior malignancy within the past 5 years except surgically cured basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychiatric, addictive, or other disorder that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic therapy except epoetin alfa No white blood cell transfusions Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational therapy No prophylactic antibiotics

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

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

Sponsor

Amgen

Etterforskere

  • Studiestol: Carol Brannan, BS, BSN, Amgen

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 1999

Datoer for studieregistrering

Først innsendt

5. juli 2000

Først innsendt som oppfylte QC-kriteriene

16. desember 2003

Først lagt ut (Anslag)

17. desember 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. desember 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. desember 2013

Sist bekreftet

1. juni 2002

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000067940
  • AMGEN-GCSF-990756
  • NCI-V00-1593

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. .

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