Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mantle Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 69 years
- Gender
- Both males and females
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 est...
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.
Tracking Information
- NCT #
- NCT01661881
- Collaborators
- Massachusetts General Hospital
- Investigators
- Study Chair: Philippe Armand, MD, PhD Dana-Farber Cancer Institute
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