Mantle Cell Lymphoma Clinical Trial
Official title:
A Multicenter, Phase 1-2 Study of MLN8237, an Oral Aurora A Kinase Inhibitor, in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab and Vincristine
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.
The drug tested in this study was called alisertib. Alisertib was tested to treat people who
have relapsed or refractory diffuse large B-cell lymphoma or other aggressive B-cell
lymphomas. This study looked at safety, any anti-tumor effect, and it also determined a
recommended dose of alisertib plus rituximab and alisertib plus rituximab and vincristine to
take into further studies. Pharmacokinetic blood samples were studied to characterize any
effects on the concentration of each of the drugs when administered together .
The study enrolled 45 patients. Participants received the following treatments:
Phase 1
- Alisertib 50 mg + rituximab in the Safety Lead-in
- Alisertib 30 mg + rituximab + vincristine in the Dose Escalation
- Alisertib 40 mg + rituximab + vincristine in the Dose Escalation
- Alisertib 50 mg + rituximab + vincristine in the Dose Escalation
All participants were asked to take one alisertib table twice a day for 7 days in each cycle
for up to 8 cycles along with rituximab on Day 1 of each cycle; some patients also received
vincristine on Day 1 and Day 8 of each cycle. All participants with documented disease
response or stabilization could continue with alisertib single-agent therapy for an
additional 2 years or more.
This multi-center trial was conducted in the USA. The overall time to participate in this
study was up to 5.2 years. Participants made multiple visits to the clinic, plus a final
visit 30 days after receiving their last dose of study drug for a follow-up assessment.
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