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

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT06319456
Phase
PHASE3
Status
Recruiting
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Conditions

  • CLL/SLL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lisaftoclax (APG-2575) — DRUG
    QD, oral administration, every 28 days for a dosing cycle.
  • Acalabrutinib — DRUG
    BID, oral administration, every 28 days for a dosing cycle.
  • Fludarabine — DRUG
    Every 28 days for a treatment cycle, administration of 6 cycles.
  • Cyclophosphamide，CTX — DRUG
    Every 28 days for a treatment cycle, administration of 6 cycles.
  • Rituximab — DRUG
    Every 28 days for a treatment cycle, administration of 6 cycles.
  • Chlorambucil — DRUG
    Every 28 days for a treatment cycle, administration of 6 cycles.

Study Details

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.

Key Dates

First listed
Mar 20, 2024
Start date
Apr 7, 2024
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lisaftoclax (APG-2575) combined with Acalabrutinib
    Lisaftoclax (APG-2575) 600 mg daily plus acalabrutinib 100 mg twice daily for a fixed duration of treatment up to 18 cycles.
  • Active Comparator: Immunochemotherapy regimens
    FCR: Fludarabine: intravenously infused at 25 mg/m2 /d on Days 1 to 3 of Cycles 1-6 cyclophosphamide: intravenously infused at 250 mg/m2 /d on Days 1 - 3 of Cycles 1 - 6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. F or R-Clb: Chlorambucil: orally administrated at 0.5 mg/kg on Days 1 and 15 of Cycles 1-6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6.

Primary Outcome Measure

Progress Free Survival (PFS) [ Time Frame: Up to 1 year ]

Central Contacts

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