Dr. Sarah Rutherford Describes Recently Opened Trial for Selinexor and RICE Chemotherapy in relapsed/refractory DLBCL

In this video Dr. Sarah Rutherford discusses a trial for men and women with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), who were not cured by initial treatment with R-CHOP or a similar chemotherapy.

The purpose of this study is to determine the maximum tolerated dose of selinexor when given in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) in patients with relapsed or refractory aggressive B-cell lymphomas. This is an open-label, phase 1 trial with a standard dose escalation schema.

Tumor biopsies and peripheral blood will be taken pre- and post-treatment with selinexor to examine the study’s biologic objectives.

Key Eligibility

  • Men and woman greater than or equal to 18 years of age
  • Confirmed diffuse large B-cell lymphoma, double/triple hit lymphoma, indolent lymphomas transformed to DLBCL or other aggressive B-cell lymphoma, and follicular lymphoma grade 3B
  • Treatment with at least two cycles of one prior anthracycline-based regimen administered with curative intent
  • Detailed eligiblity reviewed when you contact the study team

If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of DLBCL trials at Weill Cornell Medicine can be found on our clinical trials listing.

New Clinical Trial: Phase 2 Study of the Oral Selective Inhibitor of Nuclear Export Selinexor in Patients with Refractory and/or Relapsed Richter’s Transformation

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with refractory and/or relapsed Richter’s Transformation. The study sponsor is Karyopharm Therapeutics, and the principal investigator at Weill Cornell is Richard Furman 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.
  • Diagnosis of DLBCL in the setting of Richter’s Transformation from CLL.
  • Relapsed or refractory after receiving at least 1, and no more than 2, prior chemo-immunotherapy regimens.
  • Detailed eligibility reviewed when you contact the study team.

Study Details

This clinical trial is for men and women with refractory and/or relapsed Richter’s Transformation (RT).

Patients with RT currently have limited treatment options with few options having shown durability. Selinexor has shown tolerability and clinical efficacy in Phase 1 clinical trials in CLL and lymphoma patients. This study will provide information about whether selinexor will be tolerable and effective in subjects with RT.

Subjects will receive selinexor orally, twice weekly (e.g. Monday and Wednesday or Tuesday and Thursday). There is no maximum treatment duration, and subjects will receive selinexor continuously as long as they are responding to therapy and not experiencing unacceptable side effects. After discontinuing treatment, follow-up information will be collected every 3 months throughout the study at clinic visits or through telephone calls.

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.