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Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 458 to 682v10
  2. Enrollment target: 284 to 458 Primary completion date: Aug 2025 to Sep 2028 · Completion date: Aug 2026 to Sep 2029 · Interventions: APG-2575 (Drug), APG-2575 (Drug), Azacitidine (Drug), Reduced-dose HHT (Drug), standard-dose HHT (Drug) to Azacitidine (Drug), Lisaftoclax (APG-2575) (Drug), Lisaftoclax (APG-2575) (Drug), Reduced-dose HHT (Drug), olverembatinib (Drug)… · 5 morev9 Show 8 more changesShow less
    • Primary completion date: Aug 2025 to Sep 2028
    • Completion date: Aug 2026 to Sep 2029
    • Interventions: APG-2575 (Drug), APG-2575 (Drug), Azacitidine (Drug), Reduced-dose HHT (Drug), standard-dose HHT (Drug) to Azacitidine (Drug), Lisaftoclax (APG-2575) (Drug), Lisaftoclax (APG-2575) (Drug), Reduced-dose HHT (Drug), olverembatinib (Drug)…
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study arms: 6 to 8
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 3 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Aug 2024 to Aug 2025 Completion date: Aug 2025 to Aug 2026v8 Show 1 more changeShow less
    • Completion date: Aug 2025 to Aug 2026
  4. Re-verified, no change to tracked fieldsv7
  5. Enrollment target: 132 to 284 Study sites: 10 to 12 · Interventions: APG-2575 (Drug), Azacitidine (Drug), reduced-dose HHT (Drug), standard-dose HHT (Drug) to APG-2575 (Drug), APG-2575 (Drug), Azacitidine (Drug), Reduced-dose HHT (Drug), standard-dose HHT (Drug) · Eligibility criteria shortened, about 192 words · 3 morev6 Show 6 more changesShow less
    • Study sites: 10 to 12
    • Interventions: APG-2575 (Drug), Azacitidine (Drug), reduced-dose HHT (Drug), standard-dose HHT (Drug) to APG-2575 (Drug), APG-2575 (Drug), Azacitidine (Drug), Reduced-dose HHT (Drug), standard-dose HHT (Drug)
    • Eligibility criteria shortened, about 192 words
    • Study title revised
    • Study arms: 4 to 6
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 9 to 10v5
  2. Primary completion date: Aug 2022 to Aug 2024 Enrollment target: 105 to 132 · Study sites: 7 to 9 · Completion date: Aug 2023 to Aug 2025 · 2 morev4 Show 5 more changesShow less
    • Enrollment target: 105 to 132
    • Study sites: 7 to 9
    • Completion date: Aug 2023 to Aug 2025
    • Eligibility criteria expanded, about 39 words
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 6 to 7v3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 6 · Start date changed from estimate of Aug 24, 2020 to Sep 28, 2020v2 Show 2 more changesShow less
    • Study sites: 3 to 6
    • Start date changed from estimate of Aug 24, 2020 to Sep 28, 2020
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.
Trial Details
NCT Number NCT04501120
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy
Enrollment 682 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov