RecruitingPhase 3

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

United States150 participantsStarted 2026-04

Plain-language summary

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.

Who can participate

Age range18 Years – 71 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Informed Consent
✓. Participants must be between 18 and under 71 years of age
✓. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
✓. Participants must be classified as low- or intermediate-risk APL
✓. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures

Exclusion criteria

✕. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
✕. Participants who have central nervous system leukemia
✕. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe
✕. Participants who are pregnant, breastfeeding, or unwilling to use contraception
✕. Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA

What they're measuring

Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIII

Timeframe: Up to 1 cycle of consolidation therapy (each cycle is 8 weeks)

Molecular complete remission (molecular CR) rate

Timeframe: Up to 60 days of induction and 3 8-week cycles of consolidation treatment

Trial details

NCT IDNCT07504458

SponsorQuetzal Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Acute Promyelocytic Leukemia (APL) trials