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Global Trial in APG2575 for Patients With CLL/SLL

ConditionCLL/SLL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAscentage Pharma Group Inc.

About this trial

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months

ECOG Performance Status grade 0-2

Absolute neutrophil count ≥ 1.0 × 109/L

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • lisaftoclax +BTK inhibitor

    Drug

    lisaftolax + BTK inhibitor

  • BTK inhibitor

    Drug

    BTK inhibitor

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Arm 1Active comparator 1 intervention
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines

Time frame
12 months

Secondary outcomes

1

overall survival

To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascentage Pharma Group Inc.

Lead sponsor

Source ClinicalTrials.gov
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