Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to improve upon standard of care in newly diagnosed, untreated MCL patients who were transplant-eligible using drugs already established as active in MCL. The combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with tolerable toxicity.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Massachusetts General Hospital
• Treatments: Bendamustine Hydrochloride; Cytarabine; Rituximab

Criteria

Inclusion Criteria:

• Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's Hospital or Massachusetts General Hospital

• Measurable disease

• Candidate for ASCT

Exclusion Criteria:

• Prior anti-lymphoma therapy

• Pregnant or breastfeeding

• Hypersensitivity to rituximab

• Uncontrolled intercurrent illness

• Receiving other study agents

• HIV positive on combination antiretroviral therapy