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

3 december 2013 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Amgen

Utredare

  • Studiestol: Carol Brannan, BS, BSN, Amgen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 1999

Studieregistreringsdatum

Först inskickad

5 juli 2000

Först inskickad som uppfyllde QC-kriterierna

16 december 2003

Första postat (Uppskatta)

17 december 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 december 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 december 2013

Senast verifierad

1 juni 2002

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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