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

• Status: Completed
• Trial end date: 2010-08-05
• Target enrollment: 0
• Participant gender: All

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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).

• 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 non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement)

• CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed

• B-cell NHL including the following:

• Stage III follicular lymphoma

• Stage III follicular lymphoma and diffuse B-cell lymphoma

• Lymphoblastic precursor B-cell lymphoma

• Diffuse large cell B-cell lymphoma

• Centroblastic

• Immunoblastic

• Plasmablastic

• Anaplastic large cell

• T-cell-rich B-cell lymphoma

• Primary effusion lymphoma

• Intravasal B-cell lymphoma

• Primary mediastinal B-cell lymphoma

• Mantle zone lymphoma, blastoid

• Burkitt's lymphoma

• Burkitt-like lymphoma

• Aggressive marginal zone lymphoma (monocytoid)

• T-cell NHL including the following:

• Lymphoblastic precursor T-cell lymphoma

• Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS)

• Lennert's lymphoma

• T-zone lymphoma

• T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type

• Anaplastic large cell lymphoma

• ALK^+

• ALK^-

• Extranodal NK/T-cell lymphoma, nasal type

• Intestinal T/NK-cell lymphoma (with or without enteropathy)

• Hepatosplenic gamma-delta lymphoma

• Subcutaneous panniculitis-like PTCL

• Aggressive T/NK PTCL

• Anaplastic large-cell NHL, NOS

• Bone marrow involvement no more than 25%

• No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract

PATIENT CHARACTERISTICS:

Age

• 61 to 80

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• No active hepatitis infection

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• No Canadian Cardiovascular Society class III or IV angina pectoris

• No New York Heart Association class III or IV cardiac failure

• Ejection fraction at least 50%

• Fractional shortenings at least 25% by echocardiography or nuclear medicine examination

Pulmonary

• FEV1 at least 50%

• Diffusion capacity at least 50%

Other

• No uncontrolled diabetes mellitus

• No known hypersensitivity to any study medications

• No other concurrent malignancy

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study)

• No other concurrent lymphoma therapy

• No concurrent participation in another treatment study