NCT06778187 Oral-ATO for TP53-mutated Myeloid Malignancies
| NCT ID | NCT06778187 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-02-07 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Willing and able to provide informed consent 2. Age ≥18 years 3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3) 4. Presence of TP53 mutation 5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine/decitabine/oral-decitabine-cedazuridine. Exclusion Criteria: Inclusion Criteria 1. Willing and able to provide informed consent 2. Age ≥18 years 3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3) 4. Presence of TP53 mutation 5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine/decitabine/oral-decitabine-cedazuridine. Exclusion Criteria 1. Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of oral arsenic trioxide 2. Known hypersensitivity to arsenic trioxide, ascorbic acid, venetoclax or azacitidine/decitabine/oral-decitabine-cedazuridine or their excipients. 3. Uncontrolled, active infection 4. Major surgery within 4 weeks of starting the study drug, or not recovered from side effects of surgery 5. Any other serious medical conditions that could compromise study participation, in the opinion of the investigator 6. Known HIV infection or known, active hepatitis B or hepatitis C infection 7. Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible) 8. Known history of long QT syndrome (LQTS) or corrected QT interval by Fridericia formula (QTcF) ≥ 480 ms 9. Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local laboratory parameters: 1. Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation or eGFR; using CKD-EPI) \< 40 mL/min 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x the local upper limit of normal 10. Pregnant or lactating females, or females planning to become pregnant at any time during the study 11. Unwilling or unable to comply with the study protocol
Contact & Investigator
Harinder Gill, MD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06778187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06778187 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06778187 currently recruiting?
Yes, NCT06778187 is actively recruiting participants. Contact the research team at gillhsh@hku.hk for enrollment information.
Where is the NCT06778187 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06778187 clinical trial?
NCT06778187 is sponsored by The University of Hong Kong. The principal investigator is Harinder Gill, MD at The University of Hong Kong. The trial plans to enroll 30 participants.
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