Phase 3 Study of QTX-2101 for Adults with Acute Promyelocytic Leukemia

Sponsor: Quetzal Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT07504458

Provider View

This clinical trial is testing a new oral capsule treatment for adults with newly diagnosed low-risk Acute Promyelocytic Leukemia (APL). The study will evaluate how effective and safe the treatment is when combined with another medication.

Patient Parameters

Program Overview

The purpose of this Phase 3 study is to test a new oral capsule treatment for adults who have been newly diagnosed with low-risk Acute Promyelocytic Leukemia (APL). The study will look at how well the treatment works, how safe it is, and how the body processes the medication when used together with another drug called ATRA.

Eligibility Criteria

Inclusion Criteria

  • Must be between 18 and 70 years old.
  • Must have a confirmed diagnosis of Acute Promyelocytic Leukemia (APL) through genetic testing.
  • Must be classified as having low or intermediate risk APL.
  • Must be willing and able to attend all study visits, follow the treatment plan, undergo lab tests, and follow guidance on contraception and other procedures.

Exclusion Criteria

  • Have significant heart rhythm problems, such as long QT syndrome or serious arrhythmias.
  • Have leukemia that has spread to the central nervous system.
  • Have serious ongoing medical conditions or infections that are not controlled, or severe organ disease.
  • Are pregnant, breastfeeding, or not willing to use contraception.
  • Are unable to safely take the study medication due to severe nerve damage, difficulty swallowing pills, absorption issues, or allergies to the study drugs.

Locations

FACILITYZIPCITYSTATE
Quetzal Site 191010DuarteCalifornia
Quetzal Site 414203BuffaloNew York
Quetzal Site 210467The BronxNew York
Quetzal Site 322908CharlottesvilleVirginia

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