Clinical study protocol of demethylating drugs combined with arsenic trioxide in the treatment of p53 mutation-positive myelodysplastic syndromes and AML with less than 30% blasts

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048993

Enrollment

Unknown

Registered

2021-07-19

Start date

2021-07-09

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Interventions

experimental group:Demethylating drugs + ATO regimen

control group:Demethylating drugs

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed MDS or AML patients with a proportion of less than 30% of blast cells confirmed by bone marrow morphology and immunology (Except t(8,21),t(15,17),inv(16) low-risk group newly diagnosed AML), or patients with relapsed/refractory MDS or AML confirmed by bone marrow morphology and flow cytometry; 2. Significant mutation of TP53 in prognostic gene detection, and the mutation frequency is greater than 10%; 3. ECOG score=<3 points and aged 18-75 years (including 18 years old and 75 years old); 4. Bone marrow morphology suggests active bone marrow hyperplasia; 5. Normal liver and kidney function, blood bilirubin <=35µmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine <=150µmol/L; 6. Normal cardiac function; 7. Obtain informed consent signed by the patient or family member.

Exclusion criteria

Exclusion criteria: 1. Patients with clear central nervous system involvement; 2. ECG results: QT interval greater than 450 milliseconds; 3. Suffering from malignant tumors of other organs at the same time; 4. Active tuberculosis patients and HIV-positive patients; 5. Pregnant or lactating patients; 6. Allergies or obvious contraindications to any of the drugs involved in the program; 7. There are obvious contraindications to HMA chemotherapy drugs; 8. Patients with CCI>1 (comorbidity index) and ADL<100 (daily life scale); 9. Inability to understand or comply with the research protocol; 10. Past history of intolerance or allergy to similar drugs; 11. MDS patients who have received demethylating drugs in the past; 12. Participate in other clinical investigators at the same time; 13. Any other circumstance that prevents the conduct of the study.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate;Duration of Response;Relapse Free Survival;	—

Secondary

Measure	Time frame
Overall Survival;Early Death Rate;Drug Toxicity and Safety;The Clearance Rate of TP53 Positive Frequency;	—

Countries

China

Contacts

Public ContactWu Yu

West China Hospital, Sichuan University

wu_yu@scu.edu.cn+86 18980601973

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026