Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested
to treat people who have relapsed or refractory non-Hodgkin's lymphoma (NHL). The study
looked at anti-tumor activity in participants who received alisertib.
The study enrolled 48 patients. Participants were categorized as per disease subtypes into
five subtypes: Large B-Cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma,
Burkitts lymphoma and aggressive T-Cell lymphoma (Note: There were no participants enrolled
with Precursor B-lymphoblastic Leukemia/Lymphoma). Participants received:
• Alisertib 50 mg BID on Days 1 to 7
All participants took alisertib capsules approximately every 12 hours each day for 7 days
followed by a 14-day rest period in a 21-days cycle. MLN8237 was supplied in capsules of 5 or
25 mg strength.
This multi-center trial was conducted in United States. The overall time to participate in
this study was until there is evidence of disease progression or unacceptable
treatment-related toxicity. If the participant would derive benefit from continued alisertib
treatment beyond 24 months, the Sponsor was consulted for approval of further treatment.
Participants made multiple visits to the clinic, with imaging assessments every 12 weeks.
Participants discontinuing treatment prior to disease progression continue with clinic
visits, chemistry and hematology lab testing, and tumor assessments every 12 weeks up to 12
months after last dose of study drug for follow-up assessments.
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