drugset / Trial / NCT03855371

Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS

NCT03855371

Phase 1 Unknown 5 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

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'.

Timeline

Start
2018-01-10
Primary completion
2023-07
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject arsenic trioxide Small molecule 0.16 mg/kg Intravenous