NCT03356080

DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess

Clinical Efficacy and Safety of DLAAG Protocol in the Treatment of Refractory/Relapse of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess: a Multicenter, Single-arm, Prospective Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Tong Ren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with blast excess

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Decitabine	Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
DRUG	Cytarabine	cytarabine, iv,15mg/m2 q12h, Day1-Day10
DRUG	All-transretinoic acid	All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
DRUG	G-CSF	G-CSF 300ug,sc,Day 0 until CR is achieved

Timeline

• Start date: 2017-07-07
• Primary completion: 2019-07-07
• Completion: 2020-07-07
• First posted: 2017-11-29
• Last updated: 2017-11-29

Locations

6 sites across 1 country: China