Status:
Recruiting
Disease Site:
Leukemia
Phase:
Phase III
Official Title:
LOXO-BTK-20022 Phase III Open-Label, Randomized Study of Fixed Duration Pirtobrutinib Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT ID:
NCT#04965493
Link to Full Details:
Description:
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- CLL/SLL by local laboratory report (see protocol for specific criteria)
- Requirement for treatment consistent with iwCLL 2018 criteria (see protocol for specific criteria)
- Known 17p status by FISH (wildtype for 17p locus or positive for 17p deletion)
- Treatment with at least 1 line of therapy that may include a covalent BTK inhibitor. There is no limit on prior number of lines of treatment
Exclusion Criteria:
- Known or suspected Richter’s Transformation to DLBCL, prolymphocytic leukemia, Hodgkin lymphoma
- Known or suspected CNS involvement