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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Complete Remission (CR) Rate After 6 Cycles
The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.
Time frame: Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.
1 Year Progression-Free Survival
1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).
Time frame: Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.
Autologous Stem Cell Transplant (ASCT) Rate
ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)
Time frame: All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.
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