NCT02779569

A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)

Prospective, Open, Multi-center, Double Arm Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS

Detailed description

To develop a highly effective and safe protocol, a multi-center, prospective clinical trial was conducted in China, with aims to evaluate the grade III and IV hematologic toxicity and clinical efficacy of subcutaneous injection of ultra-low-dose decitabine (5 to 7 mg/m2) for treatment of myelodysplastic syndrome (MDS), while decitabine at a dose of 20 mg/m2 as a control.

Conditions

• Myelodysplastic Syndromes (MDS)

Interventions

Type	Name	Description
DRUG	decitabine

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-03-01
• Completion: 2019-08-01
• First posted: 2016-05-20
• Last updated: 2017-11-08

Locations

6 sites across 1 country: China