Status:
UNKNOWN
Mutant p53-based Personalized Trial Using Decitabine and Arsenic Trioxide on AML/MDS
Lead Sponsor:
Ruijin Hospital
Conditions:
P53 Mutation
Myeloid Malignancy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 an...
Detailed Description
TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established. In two independent clinical trials reported recently, DNA...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03855371
Start Date
January 10 2018
End Date
July 1 2024
Last Update
November 4 2022
Active Locations (1)
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1
Hematological department, Shanghai Institute of Hematology, Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025