The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with previously-treated chronic lymphocytic leukemia (CLL) who are intolerant to ibrutinib. The study is sponsored by the Acerta Pharma BV and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at firstname.lastname@example.org.
- Men and women age 18 and older.
- Diagnosis of CLL.
- At least one prior therapy for CLL.
- Intolerant to ibrutinib.
- Detailed eligibility reviewed when you contact the study team.
Btk inhibition is an established therapeutic intervention for the treatment of CLL. In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was approved 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. This study will evaluate the safety and efficacy of the second-generation Btk inhibitor, ACP-196, in subjects who have previously discontinued ibrutinib therapy due to adverse reactions. Preliminary data to date suggests that ACP-196 is very well tolerated and has robust activity as a single agent in the treatment of subjects with relapsed/refractory CLL. Additionally, PK/PD results show the 100-mg BID regimen produces optimal target coverage over 24 hours, which may provide greater clinical benefit than the QD regimen of ibrutinib. This study will explore whether ACP-196, as an alternative Btk inhibitor, with a potentially distinct safety profile, may fill an unmet need in therapeutic options for patients who are intolerant to ibrutinib.
Subjects will receive ACP-196 orally twice daily continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Subjects who are continuing to tolerate and derive clinical benefit from treatment at the end of the trial may continue to receive their study treatment after discussion with the medical monitor. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.