Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2018-02-01
• 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 hydrochloride, 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy 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; Lenograstim; 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 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 or 1 (age-adjusted)

• Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0

• No mucosa-associated lymphoid tissue (MALT) lymphoma

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

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Platelet count ≥ 100,000/mm³

• WBC ≥ 2,500/mm³

• No known hypersensitivity to the study medications

• No known HIV-positivity

• No active hepatitis infection

• Not pregnant or lactating

• Negative pregnancy test

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

• No impaired left ventricular function

• No severe cardiac arrhythmias

• No other impaired organ function

• No other serious disorder

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No prior immunosuppressive treatment with cytostatics

• No concurrent participation in other treatment studies