Status:
UNKNOWN
Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Lead Sponsor:
Xiao Li
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
16-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(...
Detailed Description
Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatmen...
Eligibility Criteria
Inclusion
- Age rang from 16 to 80 years;
- diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow);
- a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG);
- no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases;
- adequate hepatic (serum bilirubin level \<2×upper normal limit) and renal (serum creatinine \<2×upper normal limit) function tests.
Exclusion
- Female with pregnancy;
- a performance of 4-5 according to ECOG score;
- HIV positive;
- uncontrolled severe fungal infection or tuberculosis;
- with other progressive malignant diseases.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01417767
Start Date
September 1 2011
End Date
September 1 2013
Last Update
September 9 2016
Active Locations (1)
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1
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China, 200233