Clinical Trial: MLN8237 in Relapsed/Refractory Aggressive B-Cell Lymphoma Treated With Rituximab & Vincristine

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and other aggressive lymphomas including Transformed Follicular Lymphoma, and Mantle Cell or Burkitt Lymphoma. The study sponsor is Millennium Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Jia Ruan. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

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
Study Details

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.   Continue reading “Clinical Trial: MLN8237 in Relapsed/Refractory Aggressive B-Cell Lymphoma Treated With Rituximab & Vincristine”

New Clinical Trial: Alisertib (MLN8237) or Investigator’s Choice for Relapsed/Refractory Peripheral T-Cell Lymphoma

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator’s Choice (Selected Single Agent) in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for people with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL). The sponsor is Millennium Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Jia Ruan. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Study Details

The purpose of the study is to assess how well people with PTCL respond to treatment with the experimental drug Alisertib (also known as MLN8237) as compared to other PTCL treatments.

Study participants will be randomly assigned to receive Alisertib or one of the following drugs used to treat PTCL: pralatrexate, romidepsin or gemcitabine.

Alisertib has been developed to interfere with cell division, which is required for normal and cancer cell growth. By blocking an enzyme that cells need to reproduce, alistertib may slow the growth of cancer cells.

Key Eligibility

  • PTCL relapsed or refractory to at least 1 prior systemic, cytoxic therapy for PTCL
  • Must have received convential therapy (not experimental) as prior therapy

Treatment Plan

Study participants will be randomly assigned to one of two study arms:

  • Arm A: Alisertib tablet twice daily by mouth for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle for up to 32 cycles of treatment (2 years)
  • Arm B: Single-arm comparator. Participants will be assigned by the investigator to receive 1 of the following for up to 2 years:
    • Pralatrexate via infusion once weekly for 6 weeks in 7-week cycles. Cycles repeated every 7 weeks
    • Romidepsin via infusion on Days 1, 8 and 15 of a 28-day cycle. Cycles repeated every 28 days
    • Gemcitabine via infusion on Days 1, 8 and 15 of a 28-day cycle. Cycles repeated every 28 days

ASH 2011: New Treatment for T-Cell Lymphoma

By Jia Ruan, MD

Update: The below mentioned trials are closed to enrollment. 

The peripheral T-cell lymphomas (PTCL) are a heterogeneous group of lymphoid diseases that constitute less than 15 percent of all non-Hodgkin lymphomas in adults in North America. The most common subtypes are 1) Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS); 2) Anaplastic large cell lymphoma, primary systemic type (ALCL); and 3) Angioimmunoblastic T-cell lymphoma (AITL).  The PTCLs are generally aggressive, and tend to run a more relapsing and less favorable clinical course compared to B-cell NHLs.  Relapsed and refractory diseases are common. Novel and target therapies are in much need.

At the recent Annual Society of Hematology (ASH) meeting, Dr. Friedberg of the University of Rochester reported the result of a phase 2 trial of Alisertib (MLN8237), a potent inhibitor of aurora A kinase, in patients with relapsed aggressive non-Hodgkin’s lymphoma (NHL). Aurora kinases regulate mitosis during cell division. Inhibition of aurora A kinase can lead to mitotic errors and premature cell death. Alisertib is taken orally twice daily for 7 days on 21-day cycles. This phase 2 study enrolled a total of 48 patients, including 8 patients with peripheral T-cell lymphoma. The overall response rate was 32%.  Response in T-cell NHL was the most impressive at 57%: four out of eight patients responded, and the some of the responses were durable. The response rates in DLBCL and MCL were modest around 20%. Treatment-related side effects were generally tolerable and included low blood counts, fever, fatigue and inflammation in mouth. Based on these results, additional clinical trials (phase II sponsored by SWOG / NCI and phase III sponsored by Millennium) with this orally available compound are moving forward in T-cell lymphoma. Both of these studies will be available soon at Weill Cornell Medical College  (click here to read about the SWOG/NCI trial and click here to read about the Millennium trial on clinicaltrials.gov).

Dr. Advani of Stanford University discussed the updated results of an international phase 2 study of Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large cell lymphoma Continue reading “ASH 2011: New Treatment for T-Cell Lymphoma”