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 firstname.lastname@example.org.
- 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
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.