Trial intelligence / Profile preview

Lacutoclax in Relapsed or Refractory CLL/SLL

NCT07609823Phase 2

Key facts

Status
Recruiting
Start
Jul 2026
Primary completion
Mar 2028
Countries
1
Conditions
chronic lymphocytic leukemia (CLL)small lymphocytic lymphoma (SLL)
01

Overview

Phase 2, open-label, single-arm trial of lacutoclax in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), sponsored by Lupeng Pharmaceutical. Primary endpoint: Overall Response Rate assessed by Independent Review Committee. Started Jul 2026; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Lacutoclax

    All participants will receive oral Lacutoclax tablets once daily with dose escalation to a target dose of 400 mg.

03

Who it enrols

Adult patients with relapsed/refractory CLL/SLL who have progressed after prior standard therapy, with measurable disease, ECOG <=2, and adequate organ function. Excludes patients with prior BCL-2 inhibitor treatment, Richter's syndrome, CNS involvement, or recent stem cell transplant/CAR-T therapy.

04

Endpoints

Primary

  • Overall Response Rate assessed by Independent Review Committee

Secondary

  • Overall Response Rate assessed by Investigator

  • Complete response plus complete response with incomplete bone marrow recovery rate

  • Time to response

  • Duration of response

  • Time to first 50% reduction in absolute lymphocyte count or normalization of ALC

  • Progression-free survival

  • Overall Survival

  • Adverse events

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