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

3 december 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Onderzoekers

  • Studie stoel: Carol Brannan, BS, BSN, Amgen

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 1999

Studieregistratiedata

Eerst ingediend

5 juli 2000

Eerst ingediend dat voldeed aan de QC-criteria

16 december 2003

Eerst geplaatst (Schatting)

17 december 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

4 december 2013

Laatste update ingediend die voldeed aan QC-criteria

3 december 2013

Laatst geverifieerd

1 juni 2002

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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