TP53-mutated acute myeloid leukemia: how can we improve outcomes?
David A Sallman, Maximilian Stahl
https://pubmed.ncbi.nlm.nih.gov/39236289Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06778187
A Phase 2 Study of Oral Arsenic Trioxide (Arsenol 44)-Based Low-intensity Treatment for Previously Untreated or Relapsed/Refractory TP53-mutated Myeloid Malignancies
Led by The University of Hong Kong · Updated on 2025-06-10
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral arsenic trioxide (Arsenol 44) combined with ascorbic acid and low-intensity therapies for people with TP53-mutated myeloid malignancies, including acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), and chronic myelomonocytic leukemia (CMML). This phase 2 open-label study includes patients who are either newly diagnosed or have relapsed or refractory disease after prior treatments. Participants will receive treatment in 28-day cycles. Each cycle includes oral arsenic trioxide given daily from days 1 to 14, along with oral ascorbic acid during the same days. They will also receive one of several low-intensity therapies: azacitidine (injection or intravenous) for 7 days, decitabine (intravenous) for 5 days, or oral-decitabine-cedazuridine tablets for 5 days. Venetoclax may also be added for 14 days if selected by the investigator. During the study, researchers will monitor participants closely for side effects and treatment responses over 24 months. This includes tracking adverse events, blood and molecular responses, and tolerability of the combination therapy. The study aims to assess safety and effectiveness to inform potential future randomized trials. Participation involves regular visits for treatment, assessments, and laboratory tests throughout the treatment cycles and follow-up periods.
CONDITIONS
Brief Title
Oral-ATO for TP53-mutated Myeloid Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
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 for Cohort A or relapsed/refractory after 1 or more prior treatments for Cohort B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential and fertile men must agree to use approved contraception from screening until 30 days after last dose of study drugs
You will not qualify if you...
- Use of an investigational agent within 14 days before starting study treatment
- Known hypersensitivity to arsenic trioxide, ascorbic acid, venetoclax, azacitidine, decitabine, oral-decitabine-cedazuridine, or their excipients
- Uncontrolled, active infection
- Major surgery within 4 weeks before starting study drug or incomplete recovery from surgery side effects
- Any serious medical condition that could affect participation
- Known HIV infection or active hepatitis B or C infection
- Concurrent second active and non-stable malignancy (except stable non-melanoma skin cancers)
- Known history of long QT syndrome or QTcF 64 480 ms
- Significant renal or hepatic insufficiency at screening
- Pregnant or lactating females or planning pregnancy during the study
- Unwilling or unable to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral arsenic trioxide combined with ascorbic acid and investigator-chosen low-intensity therapy in 28-day cycles. Treatment includes oral arsenic trioxide and ascorbic acid for the first 14 days of each cycle, plus one of several hypomethylating agents from days 1-7 or 1-5, and venetoclax if used for 14 days.
Visits aligned with each 28-day treatment cycle
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
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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