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

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with Diffuse Large B-Cell Lymphoma (DLBCL) and other aggressive lymphomas including Transformed Follicular Lymphoma, and Mantle Cell or Burkitt Lymphoma, whose lymphoma either did not respond to treatment (“refractory”) or the treatment is no longer effective (“relapsed”).

The purpose of the study is to investigate whether the experimental drug MLN8237 has any treatment benefit when combined with rituximab (this combination is called MR) or when combined with rituximab and vincristine (called MRV). The study will also evaluate the safety and tolerability of the MR and MRV combinations.  

The study is divided into three parts. Participants will enroll into only one part of the study. Parts 1 and 2 are part of the Phase I trial. Part 3 is a Phase 2 study.

  • Part 1, Phase 1: MLN8237 + rituximab (MR); safety lead-in cohort
o   MLN8237 tablet by mouth twice/day Days 1-7 & rituximab as an intravenous (IV) infusion on Day 1 in a 21 Day cycle for up to 8 cycles
  •  Part 2, Phase 1: MLN8237 + rituximab and vincristine (MRV); dose escalation cohort to evaluate MRV and determine the best dose to use in the Phase 2 trial
o   MLN8237 tablet by mouth twice/day Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV Days 1 & 8 in a 21 Day cycle for up to 8 cycles
  • Part 3, Phase 2: MLN8237 + rituximab and vincristine (MRV); will evaluate how well study participants respond to treatment with the MRV combination
o   MLN8237 tablet twice/day Days 1-7 & rituximab as an IV infusion on Day 1 & vincristine IV Days 1 & 8 in a 21 Day cycle for up to 8 cycles

Following 8 cycles of treatment, study participants who respond to treatment may continue with MLN8237 single-agent therapy for up to 2 years.

Disease Status and/or Stage

Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma, Mantle Cell Lymphoma or Burkitt Lymphoma

Sponsor

Millennium

Key Eligibility

  • Men and women age 18 and older
  • Parts 1 and 2:
    • Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma, Mantle Cell or Burkitt Lymphoma
  • Part 3:
    • Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma (people with Mantle Cell or Burkitt Lymphoma are eligible for Parts 1 and 2 only)
    • For Part 3, must have received prior rituximab
  • Relapsed or refractory after at least 1 prior systemic treatment for aggressive lymphoma; relapsed following autologous stem cell transplant is allowed
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Jia Ruan, MD

Contact

Protocol ID

C14011

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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