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

NCT ID: NCT00004112

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-01
• Study Completion Date: 2003-03-01

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

rituximab

Intervention Type: BIOLOGICAL

CHOP regimen

Cyclophosphamide, vincristine and doxorubicin as a drip into the bloodstream (intravenously) and prednisolone (steroid) as tablets taken with or after food.

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Other Intervention Names

Rituxan; cyclophosphamide, vincristine, doxorubicin, prednisolone; chemotherapy; Lipodox, Lipodox 50, and Doxil; Prednisone Intensol, Deltasone, Rayos, steroid; Oncovin

Eligibility Criteria

Inclusion Criteria

• 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
• CD20 positive
• 19 years old and over
• WHO 0-2
• Karnofsky 70-100%
• Life expectancy at least 6 months
• Absolute neutrophil count greater than 1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement)
• Bilirubin less than 3.0 mg/dL
• Alkaline phosphatase less than 3 times upper limit of normal (ULN)
• SGOT less than 3 times ULN
• Fertile patients must use effective contraception
• HIV negative
• Nonsteroidal hormones for non-lymphoma related conditions allowed (e.g., insulin for diabetes)

Exclusion Criteria

• No prior T-cell lymphoma
• Not pregnant or nursing
• No other serious disease or medical condition that would interfere with compliance
• No other concurrent chemotherapy
• No concurrent corticosteroids (unless for prevention of nausea or vomiting)
• No concurrent radiotherapy No other concurrent investigational agents

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie M Vose, MD

Role: STUDY_CHAIR

University of Nebraska

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

P30CA036727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCLA-HSPC-9812071

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G99-1601

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0447-97-FB

Identifier Type: -

Identifier Source: org_study_id