Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

Study acronym: QUATRO-APL
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 28 → 33 locations
  2. Study sites: 28 to 29
  3. Study sites: 26 to 28
  4. Study sites: 24 to 26
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 8 entries
  5. Study sites: 23 to 24v14
  6. Study sites: 21 to 23v13
  7. Trial sites expanded: 18 → 21 locationsv12
  8. Study sites: 17 to 18v11
  9. Study sites: 16 to 17v10
  10. Study sites: 14 to 16v9
  11. Study sites: 12 to 14v8
  12. Study sites: 11 to 12v7
  13. Trial sites expanded: 7 → 11 locationsv6
  14. Study sites: 6 to 7v5
  15. Study sites: 4 to 6
    • Start date changed from estimate of Apr 2026 to Jun 8, 2026
    v4
  16. Re-verified, no change to tracked fieldsv3
  17. Study sites: 2 to 4
    • Start date: Mar 2026 to Apr 2026
    v2
  18. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.
Trial Details
NCT Number NCT07504458
Lead Sponsor Quetzal Therapeutics
Conditions
(from sponsor)		 Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, Acute Promyelocytic Leukemia
Related terms Hematologic Diseases, Hematologic Neoplasms, Leukemia, Leukemia, Promyelocytic, Acute, Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov