Phase II Study of Age‐Adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)
Study End points Primary efficacy end point of the study is the proportion of CR defined
according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety
end point is the occurrence of any of the stop treatment criteria or of any episode of
relevant toxicity, as above defined.
Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular
response is the proportion of patients with molecular rearrangements at baseline that become
negative during treatment, measured by qualitative and quantitative PCR.
OS is measured from enrollment until death from any cause. PFS is measured from the time of
enrollment until disease progression, relapse or death from any cause. DOR is measured from
the first assessment that documents response (CR or PR) to the date of disease relapse or
progression. Minimum follow up required for all patients will be 24 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
complete remission rate at the end of treatment
The primary objective is to determine the activity [complete remission rate (CR) according to Cheson 2007 criteria]
Italy: Ministry of Health