NCT02013102

A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Cttq · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.

Detailed description

Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Decitabine Injection	Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-17
• Last updated: 2013-12-17

Locations

1 site across 1 country: China