Status:
UNKNOWN
Decitabine,Cytarabine and Arsenic Trioxide for Acute Myeloid Leukemia With p53 Mutations
Lead Sponsor:
Li Junmin
Conditions:
Acute Myeloid Leukemia
P53 Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective,uncontrolled and multi-institution trial.The aim is to identify if using decitabine,cytarabine and ATO as the therapy of acute myeloid leukemia(AML) with p53 mutations has better...
Detailed Description
This study is designed as a model of precision medicine. About 1500 AML patients will be applied for TP53 sequencing. The bone marrow samples will be collected and its p53 status will be Sanger sequen...
Eligibility Criteria
Inclusion
- de novo elderly AML,AML transferred from MDS,therapy related AML
- exclude acute promyelocytic leukemia(APL)
- p53 mutations determined by DNA sequencing from bone marrow
- ECOG\<3,CCI≤1,ADL≥100
- bone marrow is active
- normal hepatic function and renal function
- normal cardiac function
- obtain informed consent
Exclusion
- APL
- without p53 mutations
- previously treated elderly AML
- central nervous system is involved
- abnormal hepatic function or renal function
- severe cardiac disease,including myocardial infarction,cardiac dysfunction
- ECG:QTc\>0.44 sec in men,QTc\>0.46 sec in women
- with other malignant tumor meanwhile
- active tuberculosis or HIV-positive patients
- woman who are pregnant or breastfeeding
- allergic to any drug in protocol or with contraindications
- hypomethylation agent(HMA) is contraindicated
- ECOG≥3,CCI\>1,ADL\<100
- cannot understand or obey the protocol
- with a history of allergies or intolerability
- with a history of decitabine therapy
- participate in other clinical trials meanwhile
- any situations that hinder trial existed
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03381781
Start Date
March 1 2018
End Date
November 1 2020
Last Update
January 4 2018
Active Locations (3)
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1
Ruijin Hospital North
Shanghai, China
2
Ruijin Hospital
Shanghai, China
3
Shanghai Institute of Hematology
Shanghai, China