A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of Lacutoclax, an oral selective BCL-2 inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lacutoclax is a potent and selective BCL-2 inhibitor with relatively weaker inhibitory activity against BCL-XL and BCL-W. Preliminary clinical data have demonstrated promising efficacy and an acceptable safety profile in patients with CLL/SLL and other B-cell non-Hodgkin lymphomas (B-NHLs). This is an open-label, single-arm, multicenter Phase II study evaluating the efficacy and safety of oral Lacutoclax tablets in patients with relapsed or refractory CLL/SLL.
Eligibility criteria
Qualifiers
Patients with confirmed R/R CLL/SLL according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
Patients who had previously received standard therapy, experienced disease progression following the most recent line of treatment (excluding intolerance), and had at least one indication for treatment prior to enrollment.
Have at least one measurable lesion.
Age ≥18 years, regardless of sex.
Disqualifiers
Known hypersensitivity to Lacutoclax or any of its excipients.
Prior treatment with a BCL-2 family inhibitor.
History of or currently suspected Richter's syndrome.
Known or suspected central nervous system (CNS) involvement.
Trial design
Treatments tested in this trial
- Lacutoclax
Treatment groups
75 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov