Spots Global Cancer Trial Database for Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

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Trial Identification

Brief Title: Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

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

Study ID: NCT01661881

Conditions

Mantle Cell Lymphoma

Interventions

Rituximab

Bendamustine

Cytarabine

Study Description

Brief 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.

Detailed Description: 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.