A Study of Lacutoclax (LP-108) in Patients With Relapsed/Refractory CLL/SLL
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lacutoclax
DrugParticipants will first undergo a dose ramp-up period of at least 4 days (Cycle 0: C0D1-C0D4), followed by continuous administration at the target dose of 400 mg once daily starting from Cycle 1. Each treatment cycle will last 28 days. Treatment will continue until disease progression, unacceptable toxicity, or fulfillment of other criteria for treatment discontinuation.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: LacutoclaxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC)
Time frame
Up to approximately 28 monthsSecondary outcomes
1
ORR assessed by Investigator(INV)
Time frame
Up to approximately 28 months2
Complete response(CR) plus complete response with incomplete bone marrow recovery (CRi) rate (CRi applicable only to patients with CLL) assessed by IRC and INV, respectively
Time frame
Up to approximately 28 months3
Time to response (TTR) assessed by IRC and INV, respectively
Time frame
Up to approximately 30 months4
Duration of response (DOR) assessed by IRC and INV, respectively
Time frame
Up to approximately 30 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov