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.

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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