RecruitingPhase 2NCT06778187

Oral-ATO for TP53-mutated Myeloid Malignancies

A Phase 2 Study of Oral Arsenic Trioxide (Arsenol ®)-Based Low-intensity Treatment for Previously Untreated or Relapsed/Refractory TP53-mutated Myeloid Malignancies


Sponsor

The University of Hong Kong

Enrollment

30 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing oral arsenic trioxide combined with other drugs as a treatment for blood cancers — specifically acute myeloid leukemia (AML), a type of bone marrow cancer called myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) — that have a specific mutation in the TP53 gene. This mutation makes these cancers particularly hard to treat. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with AML, MDS, or CMML with a confirmed TP53 mutation - You are either newly diagnosed (Cohort A) or have already received at least one prior treatment that did not work (Cohort B) - You are able to perform basic daily activities (ECOG performance status 0–2) - You are willing to use effective contraception during treatment **You may NOT be eligible if...** - You have certain heart problems (such as prolonged QT interval) - You have severe liver or kidney problems - You are pregnant or breastfeeding - You have active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral 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)


Locations(1)

Queen Mary Hospital, Hong Kong

Hong Kong, Hong Kong

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NCT06778187


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