Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek
• Treatments: Antibodies; Antibodies, Monoclonal; Carmustine; Cytarabine; Dexamethasone; Etoposide; Ifosfamide; Melphalan; Methotrexate; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL)

• Diffuse large cell B-cell lymphoma

• Grade III follicular center-cell lymphoma

• Primary mediastinal B-cell lymphoma

• CD20 positive

• First relapse after doxorubicin containing regimen

• Documented remission of at least 3 months after first-line chemotherapy

• No Epstein-Barr virus post-transplantation lymphoproliferative disorder

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No hepatic dysfunction

• Bilirubin less than 2.5 times upper limit of normal (ULN)

• Transaminases less than 2.5 times ULN

Renal:

• No renal dysfunction

• Creatinine less than 2.0 mg/dL OR

• Creatinine clearance greater than 40 mL/min

Cardiovascular:

• No severe cardiac dysfunction

• No New York Heart association class II-IV heart disease

Pulmonary:

• No severe pulmonary dysfunction

• Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement

Other:

• No active uncontrolled infection

• HIV negative

• No intolerance to exogenous protein administration

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 month since prior immunotherapy

Chemotherapy:

• See Disease Characteristics

• At least 1 month since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior radiotherapy

Surgery:

• Not specified