A phase 2 study of fixed duration therapy with pirtobrutinib and obinutuzumab in previously untreated chronic lymphocytic leukemia (POP) (DF/HCC 24-017)
This is an open-label, multicenter, single-arm phase 2 study of pirtobrutinib with obinutuzumab for participants with CLL or SLL. Eligible participants will receive 6 cycles of pirtobrutinib alone followed by an additional 6 cycles of pirtobrutinib-obinutuzumab combination therapy. All participants will stop treatment after 12 cycles in total (approximately 1 year).
If CLL progresses and requires treatment after 1-year of therapy, participants will receive retreatment with pirtobrutinib only. Participants will be followed for up to a total of 10 years. Up to 60 participants will take part in this study.
The U.S. Food and Drug Administration (FDA) has approved pirtobrutinib for continuous treatment of CLL that has relapsed or become refractory to other treatments. Pirtobrutinib is not approved for the first-line treatment of CLL/SLL nor for fixed-duration therapy. The FDA has approved obinutuzumab for the treatment of CLL.
Contact
Clinical Trials Office at [email protected] or (203) 358-8879.
Principal Investigator(s)
Steve Lo, MD
Sponsor(s)
Dana-Farber Cancer Institute
Location
Bennett Cancer Center
Stamford, CT 06902
Main: 203-358-8879