Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of immunotherapy).

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

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Histologically documented, aggressive and/or intermediate grade and high-grade B cell NHL, CD20 positive.

• Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas.

• NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score.

• Complete or partial response to first-line therapy.

• Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry.

• Cumulative total doxorubicin: <500 mg/m2

• Performance score 0-2

• Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease.

• Patients must not be pregnant or nursing.

• Informed Consent

Exclusion Criteria:

• pregnant or nursing