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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 71 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures

Exclusion Criteria

  1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG 2. Participants who have central nervous system leukemia 3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe 4. Participants who are pregnant, breastfeeding, or unwilling to use contraception 5. 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Quetzal Site 1
Duarte, California 91010
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 7
Los Angeles, California 90033
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 5
Stanford, California 94305
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 4
Buffalo, New York 14203
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 2
The Bronx, New York 10467
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 6
Houston, Texas 77030
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

Quetzal Site 3
Charlottesville, Virginia 22908
Contact:
Quetzal Therapeutics Investigator
+13126800501
ClinicalTrials@QuetzalTx.com

More Details

Status
Recruiting
Sponsor
Quetzal Therapeutics

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.