New Clinical Trial: Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 in Relapsed or Refractory CLL and Lymphomas

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with mantle cell lymphoma. The study sponsor is Bristol-Myers Squibb Research & Development, and the principal investigator at Weill Cornell is John P. Leonard, 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
  • Hodgkin’s lymphoma or B-cell malignancy
  • Relapsed after, or refractory to, prior therapy for Hodgkin’s lymphoma or B-cell malignancy
  • Detailed eligibility reviewed when you contact the study team

Study Details 

This clinical trial is for men and women with relapsed or refractory lymphomas including:

  • Hodgkin
  • Follicular
  • CLL
  • DLBCL
  • Mantle cell lymphoma

The study is evaluating the experimental drug BMS-986016 (Anti-Lag-3), to demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.

The study will be conducted in 2 parts. Part A consists of a dose escalation design and Part B consists of cohort expansion in 4 disease-restricted populations. Treatment in Part B will be initiated when the maximum tolerated dose (or maximum administered dose) for Part A has been determined.

Subjects will complete up to 3 periods of the study: Screening (up to 28 days), Treatment (up to a maximum of twelve 8-week cycles of therapy), and Clinical Follow-up (135 days following last dose of study drug). Women of child bearing potential will have additional follow-up assessments through Day 165 for home pregnancy tests. Each treatment cycle comprises 4 doses of BMS-986016 administered intravenously on Days 1, 15, 29, and 43. Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

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.

Dr. Richard Furman Discusses Role of Transplantation in High-Risk CLL

As part of an expert panel hosted by OncLive, Dr. Richard Furman discussed the role of transplantation in patients with high-risk CLL.

Previous parts of the discussion can be found here.