MedTrace Logo

Oral-ATO for TP53-mutated Myeloid Malignancies

NCT06778187 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-10

No results posted yet for this study

Summary

This is an open-label, phase 2 study of oral arsenic trioxide (Arsenol ®) in combination with ascorbic acid and investigator choice of low-intensity therapy in patients with previously untreated or relapse/refractory TP53-mutated acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), chronic myelomonocytic leukemia (CMML).

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Neoplasm
  • Chronic Myelomonocytic Leukemia
  • TP53 Gene Mutation
  • Arsenic Trioxide

Interventions

DRUG

Oral arsenic trioxide

Patients will be treated in 28-day cycles. Each cycles will comprise: Oral arsenic trixoide (10mg/day or 0.15mg/kg/day in patients \< 50kg) from Days 1-14 PLUS: * Oral ascorbic acid (1000mg/day) from Days 1-14 * Azacitidine (75mg/m2/day s.c. or i.v.) from days 1-7; OR Decitabine (20mg/m2/day i.v.) from days 1-5; OR Oral-decitabine-cedazuridine (1 tablet/day) from days 1-5. * Venetoclax (100mg-400mg/day) from Days 1-14 (if used)

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Harinder Gill, MD · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2027-02-28
Completion
2028-02-29

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778187 on ClinicalTrials.gov