Category: Clinical Trials

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: Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with mantle cell lymphoma. The study sponsor is Acerta Pharma BV, 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 greater than or equal to 18 years of age
  • Patient has confirmed Mantle Cell Lymphoma (MCL)
  • The disease has relapsed after or been refractory to at least 1 prior therapy for MCL
  • Detailed eligibility reviewed when you contact the study team

Study Details

The purpose of this study is to determine the activity of ACP-196 in subjects with relapsed or refractory MCL as measured by response rate, duration of response, progression-free survival, and time-to-next treatment.

The design and conduct of this study is supported by an understanding of the natural history and current therapies for subjects with lymphoid cancers; knowledge of the activity and safety of the first-generation Btk inhibitor (eg, ibrutinib) in subjects with hematologic cancers; and the available nonclinical and clinical information regarding ACP-196.

This study is a multicenter, open-label, randomized, parallel group study. No placebo will be administered during this study. Twenty subjects, 10 refractory and 10 relapsed, will be enrolled and will take 100 mg of ACP-196 twice per day.

This clinical trial is a Phase 2, multicenter, open-label study. Subjects will be enrolled and will take 100 mg of ACP-196 twice per day (BID) continuously for approximately 14 months. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Dr. Peter Martin Explains a Trial Testing the Combination of Ibrutinib + Palbociclib for Patients with Previously Treated Mantle Cell Lymphoma

In this video Dr. Peter Martin explains the benefits of a recently opened phase I trial of ibrutinib plus palbociclib for patients with previously treated mantle cell lymphoma (MCL). The trial will evaluate the safety and activity of the combination. This is a Weill Cornell Medical College investigator-initiated clinical trial, sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute.

If you’re interested in participating in this trial please call 646-962-2074 for more information.