QTX-2101 + ATO for Acute Promyelocytic Leukemia

(QUATRO-APL Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Quetzal Therapeutics

Disqualifiers: Heart rhythm problems, CNS leukemia, serious medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Informed Consent

I am between 18 and 70 years old.

I have APL confirmed by genetic testing.

Exclusion Criteria

I am able to safely take the study medication by mouth.

Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG

I do not have any serious ongoing medical conditions or uncontrolled infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive induction therapy with QTX-2101 and ATRA to achieve molecular complete remission

Up to 60 days

Consolidation Therapy

Participants undergo 3 cycles of consolidation therapy with QTX-2101 and ATRA

3 cycles of 8 weeks each

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• ATRA
• QTX-2101

How Is the Trial Designed?

Group I: QTX-2101 Experimental Treatment 1 Intervention

QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral)

Group II: IV ATO Active Control 1 Intervention

IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral)

Who Is Running the Clinical Trial?

Quetzal Therapeutics

Lead Sponsor