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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
University of Nebraska
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IV mantle cell lymphoma
stage II adult diffuse small cleaved cell lymphoma
stage IV diffuse small lymphocytic/marginal zone lymphoma
stage II adult diffuse mixed cell lymphoma
anaplastic large cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage III mantle cell lymphoma
stage II adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage II diffuse small lymphocytic/marginal zone lymphoma
stage III diffuse small lymphocytic/marginal zone lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
stage II mantle cell lymphoma
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: prednisone
 Drug: rituximab
 Drug: vincristine
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) With or Without Rituximab in Patients with Newly Diagnosed, Previously Untreated, Aggressive B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: September 1999

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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY 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

--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

--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

Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

Study chairs or principal investigators

Julie M. Vose,  Study Chair,  University of Nebraska   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067336; UNMC-447-97; NCI-G99-1601; UCLA-HSPC-9812071
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004112
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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