Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
Polatuzumab vedotin will be administered at a dose of 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle. Bendamustine will be administered at a dose 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle. Rituximab will be administered at a dose 375 mg/m2 i.v. on day 1 of each cycle. Each cycle is 21 days long Response rate by RECIST 1.1 is definied as the primary study endpoint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
* Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle * Bendamustine 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle * Rituximab 375 mg/m2 i.v. on day 1 of each cycle * Each cycle is 21 days long * Up to 6 cycles per patients planned
AKH Vienna, Division of Oncology Department of Medicine I
Vienna, Austria
RECRUITINGObjective response rate
Objective response rate according to RECIST 1.1
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]
Survival
Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS)
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]
Safety / Toxicity
Safety / Toxicity according to Adverse Events
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]
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