Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:

• Grade 3 follicular lymphoma

• Diffuse B-cell lymphoma, including diffuse large cell lymphoma with any of the following variants:

• Centroblastic

• Immunoblastic

• Plasmablastic

• Anaplastic large cell

• T-cell-rich B-cell lymphoma

• Primary effusion lymphoma

• Intravascular B-cell lymphoma

• Primary mediastinal B-cell lymphoma

• Burkitt's or Burkitt-like lymphoma

• Mantle cell lymphoma (blastoid)

• Aggressive marginal zone lymphoma (monocytoid)

• Previously untreated disease

• CD20-positive disease

• International Prognostic Index (IPI) score 0

• No bulky disease

• Largest single or conglomerate tumor < 7.5 cm in diameter

• No mucosa-associated lymphoid tissue (MALT) lymphoma

• No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Platelet count ≥ 100,000/mm^3

• WBC ≥ 2,500/mm^3

• Lactate dehydrogenase normal

• Not pregnant or lactating

• Fertile patients must use effective contraception during and for 1 year after study participation

• Negative pregnancy test

• No known hypersensitivity to the study medications

• No known HIV-positivity

• No active hepatitis infection

• No impaired left ventricular function

• No severe cardiac arrhythmias

• No other impaired organ function

• No other serious disorder

• No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No prior immunosuppressive treatment with cytostatics

• No planned radiotherapy to extranodal involvement

• No concurrent participation in other treatment studies