Tag: follicular lymphoma

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.

Dr. Peter Martin Explains a Recently Opened Trial Testing the Combination of Azacitidine Plus R-CHOP

In his words, Dr. Peter Martin, explains a recently opened phase 1 trial testing the combination of azacitidine plus R-CHOP in patients with high risk previously untreated diffuse large B-cell lymphoma (DLBCL) or grade 3B follicular lymphoma.

 

New Clinical Trial: An Open-label, Phase 1 Study of ACP-196 in Patients with Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular lymphoma (FL). The study sponsor is Acerta Pharma BV, and the principal investigator at Weill Cornell is Dr. Peter Martin. 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
  • Confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to >  or = 1 prior therapy for FL and which requires treatment
  • Detailed eligibility will be reviewed when you contact the study team

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and activity of 2 different schedules of ACP-196 administration in subjects with FL.

Clinical Studies have shown that targeting the B-cell receptor (BCR) signaling pathway by inhibiting Bruton tyrosine kinase (Btk) produces significant clinical benefit in patients with non-Hodgkin lymphoma including FL. Ibrutinib, a first generation Btk inhibitor, has been approved for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). In addition, in a first-in-human study of ibrutinib, 6 of 16 subjects (38%) with FL had an objective response.  Acerta Pharma BV has developed a novel second generation Btk inhibitor, ACP-196, that achieves significant oral bioavailability and potency in preclinical models. ACP-196 monotherapy is currently in Phase 1 studies in subjects with CLL and in healthy volunteers.

This study is a multicenter, open-label, randomized, parallel group study. No placebo will be administered during this study. Twenty subjects will be equally randomized (1:1 ratio) into 2 cohorts. In each cohort, subjects will take 200mg of ACP-196 per day, but with different schedules of administration:

  • Cohort 1: ACP-196 100 mg/twice daily for 28 days (= 1 cycle)
  • Cohort 2: ACP-196 200 mg/once daily for 28 days (= 1 cycle)

Treatment with ACP-196 may be continued for more than 28 days until disease progression or an unacceptable drug-related toxicity occurs. Dose modification provisions are provided in the study protocol. All subjects who discontinue study drug will have a safety follow-up visit 30 (+/- 7) days after the last dose of the study drug unless they have started another cancer therapy within that time frame.