Study of Lisaftoclax for CLL/SLL

This study is testing a drug called lisaftoclax for people with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). You may be able to join if you are 18 to 85 years old and your CLL/SLL has come back or not responded to at least one previous treatment. The main goals are to find out how safe lisaftoclax is, what side effects it might cause, and the highest dose that can be given safely. The study will look at lisaftoclax by itself and in combination with other treatments like rituximab or acalabrutinib. The study plans to enroll 144 participants. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 144 participants. It will involve a ramp-up period, dose escalation, and dose expansion for lisaftoclax as a single agent and in combination with other drugs.
What's involved
You would take lisaftoclax daily, starting with a lower dose that gradually increases over several days. The ramp-up period will vary from 3 to 8 days depending on your assigned maximum dose.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints, dose-limiting toxicity (DLT) and maximally tolerated dose (MTD), will be measured at 42 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04215809

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Ascentage Pharma Group Inc.
~144 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:Lisaftoclax

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Toxicity Endpoint: dose limiting toxicity (DLT)
Measured over 42 days
+1 more outcome measured
CLL/SLL
9 sites across 8 states
Ohio2
California1
Florida1
Massachusetts1
North Carolina1
Washington1
Queensland1
Victoria1
  • Yifan Zhai, MD, PhD · STUDY_CHAIR · Ascentage Pharma Group Inc.

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  • Primary Toxicity Endpoint: dose limiting toxicity (DLT)42 days

    DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0

  • Maximally tolerated dose (MTD)42 days

    MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment