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A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 4, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 3 to 1v16
  2. Enrollment target: 36 to 78 Primary completion date: May 31, 2024 to May 31, 2026 · Completion date: May 31, 2025 to May 31, 2027 · Eligibility criteria shortened, about 421 words · 3 morev15 Show 6 more changesShow less
    • Primary completion date: May 31, 2024 to May 31, 2026
    • Completion date: May 31, 2025 to May 31, 2027
    • Eligibility criteria shortened, about 421 words
    • Study description shortened, about 57 words
    • Study arms: 2 to 3
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: May 31, 2023 to May 31, 2024 Completion date: May 31, 2024 to May 31, 2025v14 Show 1 more changeShow less
    • Completion date: May 31, 2024 to May 31, 2025
  4. 2 versions Re-verified since May 31, 2022, no change to tracked fieldsv12-v13
  5. Eligibility criteria expanded, about 24 words Site contacts updated at 1 of 3 sites · Study description shortened, about 4 wordsv11 Show 2 more changesShow less
    • Site contacts updated at 1 of 3 sites
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 2 to 3v10
  2. Site contacts updated at 1 of 2 sitesv9
  3. Study sites: 1 to 2v8
  4. Start date changed from estimate of Jun 14, 2021 to Jul 12, 2021v7
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: May 31, 2021 to Jun 14, 2021v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: May 31, 2021 to Jun 14, 2021
  6. Start date: Apr 30, 2021 to May 31, 2021 Primary completion date: Apr 30, 2023 to May 31, 2023 · Completion date: Apr 30, 2024 to May 31, 2024v5 Show 2 more changesShow less
    • Primary completion date: Apr 30, 2023 to May 31, 2023
    • Completion date: Apr 30, 2024 to May 31, 2024
  7. Start date: Mar 31, 2021 to Apr 30, 2021 Primary completion date: Mar 31, 2023 to Apr 30, 2023 · Completion date: Mar 31, 2024 to Apr 30, 2024v4 Show 2 more changesShow less
    • Primary completion date: Mar 31, 2023 to Apr 30, 2023
    • Completion date: Mar 31, 2024 to Apr 30, 2024
  8. Phase: Phase 1 to Phase 2 Primary completion date: Aug 1, 2021 to Mar 31, 2023 · Start date: Dec 1, 2020 to Mar 31, 2021 · Primary endpoints revised (2) · 5 morev3 Show 8 more changesShow less
    • Primary completion date: Aug 1, 2021 to Mar 31, 2023
    • Start date: Dec 1, 2020 to Mar 31, 2021
    • Primary endpoints revised (2)
    • Completion date: Dec 15, 2021 to Mar 31, 2024
    • Interventions: APG2575 400mg (Drug), APG2575 600mg (Drug), APG2575 800mg (Drug) to APG-115 (Drug), APG-2575 (Drug)
    • Eligibility criteria expanded, about 85 words
    • Study description expanded, about 74 words
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  9. Start date: Aug 1, 2020 to Dec 1, 2020v2
  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 goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.
Trial Details
NCT Number NCT04496349
Lead Sponsor Ascentage Pharma Group Inc.
Conditions T-Prolymphocytic Leukemia, Non-Hodgkins Lymphoma
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov