Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Recruiting
Phase 3
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 71
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Quetzal Therapeutics · Industry
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About This Trial
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 Locations
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Eligibility Criteria
Inclusion Criteria:
1. Informed Consent
2. Participants must be between 18 and under 71 years of age
3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
4. Participants must be classified as low- or intermediate-risk APL
5. Participants m…
Contacts
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