Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

3 dicembre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Linfoma

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Investigatori

Cattedra di studio: Carol Brannan, BS, BSN, Amgen

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 1999

Date di iscrizione allo studio

Primo inviato

5 luglio 2000

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2003

Primo Inserito (Stima)

17 dicembre 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 dicembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 dicembre 2013

Ultimo verificato

1 giugno 2002

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CDR0000067940
AMGEN-GCSF-990756
NCI-V00-1593

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .