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.