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IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma (BRP)
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.
Details
| Lead sponsor | Anne Beaven, MD |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 33 |
| Start date | Tue Nov 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Feb 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Non-Hodgkin's Lymphoma
Interventions
- Bendamustine + Rituximab + Pixantrone
- Pegfilgrastim
Countries
United States