MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine
Status:
Completed
Trial end date:
2016-10-05
Target enrollment:
Participant gender:
Summary
This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib
(MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The
study has three parts as follows:
Phase 1, Part 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab.
Phase 1, Part 2: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab +
Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma
(including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2.
Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or
refractory DLBCL or TFL at recommended Phase 2 dose.
Note that in 2013 Sponsor decision was taken to not initiate the phase 2 portion of the
trial, which would have investigated the triplet at the recommended phase 2 dose identified
in part 2. This decision was based on reprioritization within the company and not on any
clinical or safety outcomes observed.