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

New Weill Cornell Study: Aurora Kinase A Inhibitor MLN8237 in Peripheral T-Cell non-Hodgkin Lymphoma

Update: this study is closed to enrollment. 
The Weill Cornell Lymphoma Program is now enrolling people in a new clinical trial for patients with peripheral T-cell lymphoma, a type of non-Hodgkin lymphoma that generally has a poor outcome with conventional chemotherapy.

The purpose of this study is to determine the effect of the experimental drug MLN8237 on patients with relapsed or refractory peripheral T-cell lymphoma. MLN8237 is an Aurora Kinase A inhibitor that has been developed to interfere with cell division, which is required for cancer to grow. It has been shown to have anti-cancer activity in laboratory studies as well as in patients who have non-Hodgkin lymphoma including peripheral T-cell lymphoma in earlier phase I/II studies.

MLN8237 is available as a tablet. Patients will take MLN8237 on Days 1-7, twice a day with 8 ounces of water. Patients will continue with this treatment every 3 weeks for up to a year as long as their disease does not get worse. Whether patients remain on study treatment or not, the study physician will follow their health status for a maximum of 2 years from study enrollment.

Key eligibility:

  • Relapsed/refractory peripheral T-cell non-Hodgkin lymphoma
  • Must have received at least one course of prior systemic therapy which may include chemotherapy, antibody therapy or immunotherapy
  • May have received prior radiation in combination with systemic therapy
  • Must not have received a previous allogeneic stem cell transplant or be within 90 days of autologous stem cell transplant
  • Detailed eligibility reviewed when you contact the study team

For more information about the study, call June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

The physician leading the study at Weill Cornell is Dr. Jia Ruan. Click here to read Dr. Ruan’s clinical and research profile.

Click here to view all current lymphoma clinical trials at Weill Cornell Medical College.