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

• Status: Completed
• Trial end date: 2007-01-01
• 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, plus the addition of 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.

• In relapse after primary conventional chemotherapy

• Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse

• Treatment of CNS or meningeal disease (cytology-negative CSF) if present

• Treatment of CNS or meningeal disease (cytology-negative CSF) if present.

• Cumulative total doxorubicin dosage <500 mg/m2

• Performance score: 0-2

• Prior malignancies eligible if treated for cure and without active disease

• Patients must not be pregnant or nursing.

• Prior Immunotherapy is allowed

• Signed Informed Consent

• Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl

• Bilirubin <1.5 x normal, SGOT <2.5 x normal

• Serum creatinine <1.5 mg/dl

• Ejection fraction > 45% or > 40% with normal wall motion

• HIV negative

• FEV1, DLCO > 50% predicted

Exclusion Criteria:

• Pregnant or nursing