IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma
Status:
Completed
Trial end date:
2017-02-17
Target enrollment:
Participant gender:
Summary
This is a phase I trial of the combination of bendamustine, rituximab and pixantrone in
patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will be
used to determine the maximum tolerated dose (MTD) of the combination. A static dose of
bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each
cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in
sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be
determined based on DLTs that occur during the first 2 cycles of the drug combination.
Phase II did not proceed as planned due to withdrawal of pixantrone from the US.