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

3. december 2013 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Lymfom

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

Studiestol: Carol Brannan, BS, BSN, Amgen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 1999

Datoer for studieregistrering

Først indsendt

5. juli 2000

Først indsendt, der opfyldte QC-kriterier

16. december 2003

Først opslået (Skøn)

17. december 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2013

Sidst verificeret

1. juni 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000067940
AMGEN-GCSF-990756
NCI-V00-1593

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .