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

Part of paid clinical trials in Duarte, California.

Sponsor
Quetzal Therapeutics
Study ID
NCT07504458
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acute Promyelocytic Leukaemia
  • Acute Promyelocytic Leukemia
  • Acute Promyelocytic Leukemia (APL)
  • Acute Promyelocytic Leukemia With PML-RARA
  • Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

Eligibility Criteria

Sex
ALL
Age
18 Years - 71 Years
Healthy Volunteers
Not accepted

Interventions

  • QTX-2101 + ATRA — DRUG
    The experimental regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, QTX-2101 is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.
  • IV arsenic trioxide (ATO) + ATRA — DRUG
    The comparator regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, IV ATO is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle.

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: QTX-2101
    QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)
  • Active Comparator: IV ATO
    IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)

Primary Outcome Measure

Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII [ Time Frame: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Quetzal Site 1DuarteCalifornia91010
Quetzal Therapeutics Investigator
[email protected]
+13126800501
Quetzal Site 5StanfordCalifornia94305
Quetzal Therapeutics Investigator
[email protected]
+13126800501
Quetzal Site 4BuffaloNew York14203
Quetzal Therapeutics Investigator
[email protected]
+13126800501
Quetzal Site 2The BronxNew York10467
Quetzal Therapeutics Investigator
[email protected]
+13126800501
Quetzal Site 6HoustonTexas77030
Quetzal Therapeutics Investigator
[email protected]
+13126800501
Quetzal Site 3CharlottesvilleVirginia22908
Quetzal Therapeutics Investigator
[email protected]
+13126800501

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