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A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

NCT06319456 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2024-05-29

No results posted yet for this study

Summary

This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.

Conditions

  • CLL/SLL

Interventions

DRUG

Lisaftoclax (APG-2575)

QD, oral administration, every 28 days for a dosing cycle.

DRUG

Acalabrutinib

BID, oral administration, every 28 days for a dosing cycle.

DRUG

Fludarabine

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUG

Cyclophosphamide，CTX

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUG

Rituximab

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUG

Chlorambucil

Every 28 days for a treatment cycle, administration of 6 cycles.

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Lugui Qiu, M.D., Ph.D. · Hematology Hospital of the Chinese Academy of Medical Sciences

  • Keshu Zhou, M.D., Ph.D. · Henan Province Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-07
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319456 on ClinicalTrials.gov