Tag: Jia Ruan MD

REDLAMP 6: Entecavir vs. Lamivudine in Preventing Hepatitis B Reactivation in Untreated DLBCL

Reactivation of the Hepatitis B virus (HBV) can be a serious and life threatening complication for lymphoma patients who receive rituximab based treatment like R-CHOP. In this video Dr. Jia Ruan explained the results from a randomized phase 3 trial published in JAMA (The Journal of the American Medical Association). In this study researchers compared the effectiveness of Entecavir and lamivudine in preventing HBV reactivation and clinically significant hepatitis in patients with DLBCL, who are receiving R-CHOP.

Previous #REDLAMP entries can be viewed on our Youtube channel.

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ASCO2015: A phase I/II Trial of the Combination of Romidepsin and Lenalidomide in Patients with Relapsed/Refractory Lymphoma and Myeloma: Activity in T-cell Lymphoma.

Picture2By Dr. Jia Ruan 

Romidepsin, a histone deacetylase inhibitor, and lenalidomide, an immunomodulatory agent, have previously shown efficacy and a lack of cumulative toxicity in the treatment of patients with relapsed/refractory lymphoma and myeloma. Results from phase I of this trial were previously reported in ASCO 2014. The maximum tolerated dose in cycle 1 for romidepsin was 14 mg/m2 IV on days 1, 8, and 15, while lenalidomide was 25 mg oral on days 1-21 of a 28-day cycle. In this trial patients were treated to progression or intolerance.  Results of patients with t-cell lymphoma were reported at the 2015 ASCO meeting.

21 patients (10 CTCL, 11 PTCL) with a median age of 64 were enrolled in this trial. 15 of these patients were treated at the maximum tolerated dose. 19 of these patients were evaluable for efficacy with an overall response rate of 53%. For patients the median time of response was 7.3 weeks, median event free survival was 15.5 weeks, and median overall survival was not reached. 10 out of 21 patients remained on therapy with 7 discontinued for disease progression, 3 for toxicity, and 1 for stem cell transplant. Side effects were generally expected and manageable.

Results from this study confirm that the romidepsin and lenalidomide combination has significant activity in relapsed and refractory T-cell lymphoma. This study demonstrated that novel biologic agent and combinations can be effective and well-tolerated treatment options for patients with T-cell lymphoma, who may be poor candidates for intensive therapy or have chemotherapy-resistant disease.

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.