Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma

• Presenting with at least one of the following:

• Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by immunophenotyping

• Positive for cyclin D1 by immunostaining

• Presence of t(11,14) by cytogenetic analysis

• Molecular evidence of bcl-1/IgH rearrangement

• Stage I-IV disease

• Stage III or IV if nodular histology mantle cell lymphoma present

• Any stage for other mantle cell histologies

• No mantle zone histology

• No active CNS disease

• No symptomatic meningeal lymphoma

• No known CNS parenchymal lymphoma

• Lumbar puncture showing mantle cell lymphoma allowed

• Bidimensionally measurable disease greater than 1 cm

• Nonmeasurable disease includes the following:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Inflammatory breast disease

• Lymphangitis cutis/pulmonis

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Lesions in a previously irradiated area

PATIENT CHARACTERISTICS:

Age:

• 18 to 69

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all of the following criteria:

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

• AST no greater than 3 times ULN

• Liver biopsy shows no greater than grade 2 fibrosis and no cirrhosis

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• LVEF at least 45% by MUGA or echocardiogram

Other:

• No known hypersensitivity to murine products

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 1 prior dose of rituximab

Chemotherapy:

• No more than 1 prior cycle of chemotherapy

• At least 3 weeks since prior chemotherapy

• No other concurrent chemotherapeutic agents

Endocrine therapy:

• No chronic use of oral corticosteroids for ongoing medical condition

• No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g., insulin for diabetes)

• Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage, carmustine pneumonitis, or as an anti-emetic allowed

Radiotherapy:

• No prior radiotherapy for mantle cell lymphoma

• Concurrent palliative radiotherapy allowed

• Concurrent cranial radiotherapy for asymptomatic meningeal lymphoma allowed

Surgery:

• At least 2 weeks since prior major surgery