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A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study sites: 7 to 9v8
  2. Phase: Phase 1/2 to Phase 1v7 Show 8 more changesShow less
    • Primary endpoints: 7 to 6
    • Enrollment target: 122 to 100
    • Study completion date: Apr 1, 2027 to May 1, 2027
    • Interventions: APL-4098 (Drug), Azacitidine and APL-4098 (Drug) to APL-4098 (Drug), Azacitidine and APL-4098 (Drug), Azacitidine and Venetoclax and APL-4098 (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 10 to 1
    • Study arms: 4 to 3
    • Study title shortened, about 2 words
  3. Study sites: 6 to 7v6
  4. Primary endpoints: 8 to 7
    • Enrollment target: 112 to 122
    • Study sites: 4 to 6
    v5
  5. Study sites: 1 to 4v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2024 to Jun 4, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).
Trial Details
NCT Number NCT06372717
Lead Sponsor Apollo Therapeutics Ltd
Conditions
(from sponsor)		 Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia (AML)
Related terms Anemia, Refractory, with Excess of Blasts, GATA2 Deficiency, Leukemia, Myeloid, Acute
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov