Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

a study on Acute Promyelocytic Leukemia Leukemia Promyelocytic Leukaemia Neoplasms Hematologic Disease Hematologic Neoplasms

Summary

Eligibility
for people ages 18-71 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Kiran Naqvi (uci)

Description

Summary

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.

Official Title

A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia

Keywords

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, APL, Hematology, Oncology, Leukemia, Hematologic Disease, Drug Therapy, Therapeutics, Blood Cancer, Heme Malignancy, Arsenic, low-risk APL, standard-risk APL, Leukemia, Promyelocytic, Acute, Neoplasms, Hematologic Diseases, Hematologic Neoplasms, Tretinoin, Arsenic Trioxide, QTX-2101 + ATRA, IV arsenic trioxide (ATO) + ATRA, IV ATO

Eligibility

You can join if…

Open to people ages 18-71

  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

You CAN'T join if...

  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

Locations

  • Quetzal Site 31 accepting new patients
    Irvine California 92612 United States
  • Quetzal Site 32 accepting new patients
    Orange California 92868 United States
  • Quetzal Site 7 accepting new patients
    Los Angeles California 90033 United States
  • Quetzal Site 1 accepting new patients
    Duarte California 91010 United States
  • Quetzal Site 5 accepting new patients
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Kiran Naqvi (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 53 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Quetzal Therapeutics
Links
Oral arsenic trioxide ORH-2014 pharmacokinetic and safety profile in patients with advanced hematologic disorders
ID
NCT07504458
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated