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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
University of Nebraska Identifier:
First received: December 10, 1999
Last updated: April 13, 2010
Last verified: April 2010

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 Biological: rituximab Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Study Start Date: September 1999
Study Completion Date: March 2003
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00004112

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)
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information Identifier: NCT00004112     History of Changes
Other Study ID Numbers: 447-97
P30CA036727 ( U.S. NIH Grant/Contract )
Study First Received: December 10, 1999
Last Updated: April 13, 2010

Keywords provided by University of Nebraska:
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Hormones processed this record on September 21, 2017