QTX-2101 (oral arsenic) plus ATRA for adults with low- or intermediate-risk APL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 3 study enrolls adults with newly diagnosed low- or intermediate-risk APL confirmed by t(15;17) or PML-RARA. Participants will receive either an oral capsule formulation of arsenic (QTX-2101) plus ATRA or standard IV arsenic trioxide (ATO) plus ATRA according to protocol dosing schedules. The study will track remission rates, safety events, and the pharmacokinetics of the oral formulation with regular clinic visits, laboratory tests, and ECG monitoring. The goal is to determine whether the oral option can match the effectiveness and safety of IV ATO while offering more convenient administration.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham (UAB)
  Birmingham, Alabama, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCI Health - UCI Medical Center
  Orange, California, United States Recruiting
• Stanford University School of Medicine
  Stanford, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.