Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma

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.

This was a PII single-arm design to determine whether the regimen looked promising for further study.

Primary Objective

• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.

Secondary Objectives

• To assess safety.
• To estimate the rate of complete remission (CR), unconfirmed CR (CRu), partial remission (PR), stable disease (SD) and progressive disease (PD).
• To estimate the rate of successful stem cell mobilization after RB/RC in responding patients.
• To estimate the proportion of patients who can successfully complete the regimen and proceed to autologous stem cell transplantation (ASCT).
• To estimate the rate of neutrophil and platelet engraftment after ASCT.
• To estimate the CR/CRu and PR rate for patients with blastoid variant MCL.
• To estimate the rate of minimal residual disease (MRD)-negativity at treatment completion.

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