New Clinical Trial: A Phase 3 Study of ACP-196 vs. Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously-treated high-risk (17p deletion or 11q deletion) CLL. The study sponsor is Acerta Pharma BV, 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 CLL with high-risk prognostic factors (17p deletion or 11q deletion)
  • At least one prior therapy
  • Detailed eligibility reviewed when you contact the study team

Study Summary

This clinical trial is for men and women with previously-treated high-risk (17p deletion or 11q deletion) CLL.

In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was awarded marketing approval in the United States for the treatment of patients with CLL who have had ≥ 1 prior therapy or 17p deletion based on high response rates with few drug-related toxicities. However, ibrutinib is not without its adverse reactions. Furthermore, subjects with 17p deletion have shown the poorest outcome on ibrutinib treatment. This study will evaluate the safety and activity of a potent, second-generation Btk inhibitor, ACP-196, versus ibrutinib in subjects with previously treated CLL with high-risk cytogenetics (such as 17p deletion). ACP-196 has been well tolerated in healthy volunteers and subjects with CLL or Richter’s syndrome. Despite poor prognostic characteristics in the CLL study population, ACP-196 has induced sustained decreases in lymphadenopathy, and based on the current existing data, provides more rapid reduction and/or resolution of lymphocytosis than ibrutinib. Additionally, no specific drug-related toxicity has been identified to date for ACP-196. The study will provide more information about whether ACP-196 can benefit subjects with high risk CLL over ibrutinib treatment in terms of safety and efficacy.

Subjects will be randomized to receive either ACP-196 orally twice daily or ibrutinib orally once daily. Both treatments are to be taken continuously throughout the study as long as they are responding to therapy and not experience unacceptable side effects. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.

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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