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Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004112
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus rituximab is more effective than combination chemotherapy alone for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's lymphoma that has not been treated previously.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: rituximab
Drug: vincristine sulfate
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Prednisone    Vincristine sulfate    Vincristine    Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 1999

Detailed Description:

OBJECTIVES: I. Determine whether the addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) increases the failure-free survival of patients with newly diagnosed, previously untreated, aggressive B-cell non-Hodgkin's lymphoma. II. Determine whether the addition of rituximab changes the toxicity profile attributed to CHOP chemotherapy in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, histology (diffuse small cleaved cell, diffuse mixed, and diffuse large cell vs immunoblastic large cell, mantle cell, and marginal zone), and risk group (low vs intermediate vs high). Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on day 1, followed by cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone for 5 consecutive days beginning on day 3. Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone daily for 5 consecutive days beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients will be followed for 3 years.

PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this study within 3 years.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, aggressive (stage II-IV) B-cell non-Hodgkin's lymphoma, including but not limited to: Mantle cell Diffuse large cell Diffuse mixed cell Anaplastic large cell (B-cell type) Diffuse small cleaved cell Marginal zone lymphoma No prior T-cell lymphoma CD20 positive

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement) Hepatic: Unless due to NHL: Bilirubin less than 3.0 mg/dL Alkaline phosphatase less than 3 times upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other serious disease or medical condition that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids (unless for prevention of nausea or vomiting) Nonsteroidal hormones for nonlymphoma related conditions allowed (e.g., insulin for diabetes) Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004112

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
United States, Nebraska
University of Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198-3330

Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)

Investigators
Study Chair:     Julie M. Vose, MD     University of Nebraska    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067336, UNMC-447-97, UCLA-HSPC-9812071, NCI-G99-1601
First Received:   December 10, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00004112
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II adult diffuse small cleaved cell lymphoma  
stage II adult diffuse mixed cell lymphoma  
stage II adult diffuse large cell lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage IV adult diffuse small cleaved cell lymphoma  
stage IV adult diffuse mixed cell lymphoma  
stage IV adult diffuse large cell lymphoma  
stage III mantle cell lymphoma  
stage IV mantle cell lymphoma  
anaplastic large cell lymphoma
stage II mantle cell lymphoma
stage II small lymphocytic lymphoma
stage II marginal zone lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Prednisone
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Vincristine
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Mantle cell lymphoma
Doxorubicin
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Large-Cell, Anaplastic
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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