Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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(MDS).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiao Li
• Treatments: Azacitidine; Cytarabine; Decitabine; Homoharringtonine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.