New Clinical Trial: Phase 2 Study of High Dose Chemotherapy with Autologous Stem Cell Transplant followed by Maintenance Therapy with Romidepsin for the Treatment of T-cell Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with T-cell lymphoma. The study sponsor is Memorial Sloan Kettering Cancer Center, and the principal investigator at Weill Cornell is Jia Ruan, M.D., Ph.D.. 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 16 and older.
  • T-cell non-Hodgkin lymphoma (NHL).
  • Complete or partial response to prior therapy.
  • Eligible for stem cell transplant.
  • No prior autologous or allogenic transplant.

Study Details

This clinical trial is for men and women with T-cell non-Hodgkin lymphoma. The purpose of the study is to test the benefit of a chemotherapy drug called romidepsin in men and women who have undergone autologous stem cell transplant.

Romidepsin has been FDA-approved for treating relapsed T-cell lymphoma. It is possible that in people who are at risk of their disease coming back (relapse), romidepsin could be used to prevent or delay the T-cell lymphoma from returning. The study will determine if giving romidepsin after the autologous stem cell transplant is safe and will prevent or delay the T-cell lymphoma from returning.

Participants will receive high dose chemotherapy followed by the stem cell transplant. Between 42 and 80 days after the transplant, participants will receive their first dose of romidepsin via infusion. Participants will continue to receive romidepsin every other week until 1 year after the stem cell transplant. If a participant’s disease has not progressed 1 year after the transplant, he/she will continue on romidepsin for another year.

Dr. Jia Ruan Speaks about Novel Therapeutic Combinations for Mantle Cell Lymphoma

In a segment taken from the 2014 meeting of the American Society of Hematology (ASH), Dr. Jia Ruan answered questions about the difficulties faced in treating patients with mantle cell lymphoma and the novel therapeutic combinations that could help improve treatment.

The video can be seen here.

Ibrutinib Demonstrates Continued Efficacy for CLL Patients at 3 Year Follow-up

Previous studies have demonstrated the efficacy ibrutinib (Imbruvica), an oral inhibitor of Bruton’s tyrosine kinase, has as treatment for patients with CLL. This has led to its approval by the FDA for previously treated patients with CLL and patients with CLL who have deletion 17p regardless of prior therapy. In a paper published online in Blood, a group of investigators, including Richard R. Furman, published long term follow up results from the original phase II studies of ibrutinib in patients with CLL. The paper presents results from a median three-year follow-up of 132 treatment-naive and relapsed/refractory symptomatic patients with CLL or SLL, receiving single agent ibrutinib. Longer treatment with ibrutinib was associated with improvement in response quality, durable remissions, and with diminishing toxicity and adverse side effects. For the treatment naïve group of patients, the 30 month progression free survival was 96%. For the relapsed refractory patients, the 30 month PFS was 69%, with disease progression being seen primarily in the patients with relapsed del(17)(p13.1) and/or del(11)(q22.3) disease. Findings from this study provide further evidence that ibrutinib is an effective and well tolerated long-term treatment for patients with CLL.

A full listing of available CLL trials at WCMC can be found here. Please look to this space for further developments about ibrutinib and CLL trials.