Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06778187

Oral-ATO for TP53-mutated Myeloid Malignancies

Led by The University of Hong Kong · Updated on 2025-06-10

30

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Oral-ATO for TP53-mutated Myeloid Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide informed consent
  • Age 18 years or older
  • Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), or chronic myelomonocytic leukemia (CMML) by WHO 2022 criteria
  • Presence of TP53 mutation
  • Previously untreated patients (Cohort A) or patients who failed one or more prior treatments (Cohort B)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Women of childbearing potential and fertile men must agree to use approved contraception from screening until 30 days after last dose of study drugs
Not Eligible

You will not qualify if you...

  • Use of an investigational agent within 14 days before starting study treatment
  • Known allergy to arsenic trioxide, ascorbic acid, venetoclax, azacitidine, decitabine, oral-decitabine-cedazuridine, or their ingredients
  • Uncontrolled active infection
  • Major surgery within 4 weeks before starting treatment or not recovered from surgery effects
  • Serious medical conditions that could affect participation, as judged by the investigator
  • Known HIV infection or active hepatitis B or C infection
  • Concurrent second active and unstable cancer (except stable non-melanoma skin cancers)
  • History of long QT syndrome or QTcF interval 480 ms or higher
  • Significant kidney or liver problems at screening unless due to hemolysis
  • Pregnant or breastfeeding women or planning pregnancy during the study
  • Unwilling or unable to follow the study protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Queen Mary Hospital, Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

H

Harinder Gill, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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