New Clinical Trial: Phase 2B Open-label, Randomized Two-arm Study of Selinexor with Low Dose Dexamethasone in Patients with Relapsed/Refractory DLBCL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study sponsor is Karyopharm, and the principal investigator at Weill Cornell is Peter Martin, M.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 18 and older
  • Pathologically confirmed DLBCL whose disease is relapsed and/or refractory with documented evidence of disease progression after the most recently administered chemotherapy regimen and who in the opinion of the investigator are not candidates for high-dose chemotherapy with stem cell rescue
  • Patients must have received at least 2 but no more than 4 prior multi-agent therapies
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is for men and women with Diffuse Large B-Cell Lymphoma (DLBCL) and were previously treated for this disease.

For patients who are not cured with front-line therapy, DLBCL is a very difficult disease to manage with only limited treatment options. Selinexor has demonstrated anti-tumor activity in heavily pretreated patients with various subtypes of DLBCL. This study is designed to confirm selinexor activity with relapse and/or refractory DLBCL in patients who have had at least two but no more than four prior multi-agent therapies and are not eligible for high dose chemotherapy with stem cell rescue at the time of study entry.

This is a randomized, two-arm, multicenter, open-label Phase 2b study of the selinexor high (100 mg) and selinexor low (60 mg) doses with low dose dexamethasone given orally to patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit. Two hundred patients (100 per arm) with relapsed/refractory DLBCL who meet eligibility criteria will be enrolled and randomized in a 1:1 ratio of high (100 mg) to low (60 mg) selinexor doses.

New Clinical Trial: Nivolumab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) that have Either Failed or are Not Eligible for Autologous Stem Cell Transplant

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, that have either failed or are not eligible for Autologous Stem Cell Transplant. The study sponsor is Bristol-Myers Squibb, and the principal investigator at Weill Cornell is Dr. John Leonard. 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 equal to or greater than 18 years of age
  • A performance status of 0 or 1
  • Biopsy confirmation of relapsed, refractory DLBCL, or transformed lymphoma (TL) prior to the initiation of study drug
  • Prior treatment as defined below:
    – Subjects with relapsed or refractory DLBCL or TL after high-dose conditioning chemotherapy and ASCT, or
    – Subjects with relapsed or refractory DLBCL or TL after at least 2 prior multi-agent  chemotherapy regimens if ASCT ineligible. Ineligibility for ASCT will be determined  using local institutional criteria
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is testing a drug called Nivolumab (also known as BMS-936558, a monoclonal antibody) as therapy for subjects with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after failure of autologous stem cell transplant (ASCT). The purpose of this study is to test the effectiveness, safety, and tolerability of the investigational drug Nivolumab.

Subjects enrolled on this study will receive Nivolumab 3 mg/kg intravenously on the start of every 2 week cycle.  The study medication may be interrupted, withheld or stopped for different reasons. However, subjects will be asked to follow up periodically for two years after ending treatment.

Clinical Trial for Patients with Relapsed or Refractory DLBCL

A Phase I/II study of combination epigenetic therapy with azacitidine and vorinostat in patients with relapsed and refractory DLBCL

Update: this study is closed to enrollment. 

Researchers have begun to understand how reversible changes in expression of genes contribute to the development of cancer and allow cancer cells to become resistant to the effects of chemotherapy. These reversible changes are termed “epigenetics” since they do not involve mutations in genes themselves.

In this trial we are studying a combination of 2 drugs that may work by reversing epigenetic changes in patients with diffuse large B-cell lymphoma (DLBCL) that has not responded well to chemotherapy.