Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2013-04-01
• 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. 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 if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: EBMT Solid Tumors Working Party
• Collaborator: Lymphoma Trials Office
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Melphalan; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)

• No evidence of transformation to high grade or diffuse large B-cell NHL

• CD20 positive with no evidence of transformation

• Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen

• Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy

• Platelet count greater than 100,000/mm^3 after induction chemotherapy and before randomization

• No CNS involvement

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin normal

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

• Alkaline phosphatase no greater than 2 times ULN

• Hepatitis B negative

• Hepatitis C negative

Renal:

• Creatinine no greater than 2 times ULN

• BUN no greater than 2 times ULN

Cardiovascular:

• No inadequate cardiac function

Pulmonary:

• No inadequate pulmonary function

Other:

• Not pregnant or nursing

• HIV negative

• No other uncontrolled serious medical conditions

• No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• More than 12 months since prior CD20 therapy, including rituximab

• No prior peripheral blood stem cell transplantation

Chemotherapy:

• See Disease Characteristics

• No more than 3 prior chemotherapy regimens for NHL

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to greater than 30% of bone marrow

Surgery:

• Not specified