Clinical trial · Interventional
Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS
Combination of Decitabine and ATO to Treat AML/MDS Expressing a Classified Type of Mutant p53
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established. Here the investigators try to evaluate the side effect and treatment potential of DAC+ATO in p53 mutated high-risk AML/MDS patients. About 200 AML/MDS patients will be sequenced for TP53 sequence before recruitment. The investigators estimated about 5 patients, based on the reported p53 mutation frequency in AML/MDS, will be p53-mutated. In the trial, the investigators will selectively recruit the mp53 AML/MDS patients that are predicted to respond to DAC+ATO regimen with highest chance (based on the relevant basic studies). The investigators designate mutant p53-based clinical trials as 'PANDA (P53 AND Arsenic)-Trials'.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aml | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloid Malignancy | — | UNRESOLVED | — |
| P53 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine plus arsenic trioxide
- description
- decitabine: 20mg/m2/d, intravenously, d1-d5, q4w arsenic trioxide: 0.16mg/kg/d, intravenously, d1-d5, q4w(maximum dose: 10mg/d)
- interventionNames
- Drug: Decitabine
- Drug: Arsenic Trioxide
Primary outcomes (1)
- measure
- side effect
- timeFrame
- during the whole treatment
- description
- evaluate the side effects of current regimen
Secondary outcomes (1)
- measure
- Overall response rate
- timeFrame
- at the end of cycle 4 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Occurrence of p53 mutants that are predicted to respond to ATO+DAC with highest chance * Patients newly diagnosed with myelodysplastic syndromes. * ECOG Performance status ≤ 3. * Aged from 18 to 75. * Active bone marrow hyperplasia indicated by morphology * Normal liver and renal function, bilirubin ≤35μmol/L, ASL/ALT lower than 2xULN, creatinine level ≤150μmol/L * Normal cardiac function * Written Informed consent. Exclusion Criteria: * Patients previously treated. * Confirmed CNS involvement. * Abnormal liver function which does not meet the inclusion criteria. * Severe cardiac diseases including myocardial infarction or heart insufficiency. * QT interval ≥450ms on ECG. * With other visceral malignancy. * Active tuberculosis or HIV(+). * Patients with pregnancy or lactation. * Allergic or significantly contraindicated to any drugs involved in intervention. * Significantly contraindicated to HMA chemotherapy. * ECOG performance status ≥3, CCI \>1, ADL \<100. * Unable to understand or follow the study protocol. * Previous intolerance or allergy history to similar drugs. * Aged \<18 yrs or \>75yrs * MDS patients previously treated with decitabine. * Participation at same time in another study in which investigational drugs are used. * Any other conditions interfering the study.
References
Publications (0)
Data not yet available