Status:
WITHDRAWN
Decitabine and Arsenic Trioxide for Myelodysplastic Syndrome(MDS)
Lead Sponsor:
Li Junmin
Conditions:
Myelodysplastic Syndromes
P53 Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a prospective,controlled and multi-institution trial.The aim is to identify if using decitabine and Arsenic Trioxide(ATO) as the therapy of Myelodysplastic Syndrome(MDS) has better relapse fre...
Detailed Description
300 MDS patients will be recruited for trial. They will be randomly administrated with ATO + decitabine (n=200) or decitabine alone (n=100). The RSF, CR ratio, overall survival will be compared betwee...
Eligibility Criteria
Inclusion
- de novo MDS
- The Revised International Prognostic Scoring System(IPSS-R) is intermediate,poor or very poor
- 18-75years old(including 18-year-old and 75-year-old patients)
- ECOG\<3,CCI≤1,ADL≥100
- bone marrow is active
- normal hepatic function and renal function
- normal cardiac function
- obtain informed consent
Exclusion
- previously treated MDS patients
- 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 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03377725
Start Date
March 20 2018
End Date
March 31 2018
Last Update
August 16 2023
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