CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML
Status:
Recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after HLA
matched HSCT in high risk and refractory AML patients as compared with fludarabine based
conditioning regimen(FBA).
Study design: open-labed, prospective, multicenter, randomized control study Number of
subjects: 60 each group
Treatment:
CBA group: CBA as HSCT conditioning which including cladribine 5mg/m2 day -6 to day -2 ,
busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.
FBA group: FBA as HSCT conditioning which including fludarabine 30mg/m2 day -6 to day -2,
busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators:
Changhai Hospital Chengdu PLA General Hospital Fujian Medical University Union Hospital Tang-Du Hospital Tongji Hospital Wuhan Union Hospital, China Xiangya Hospital of Central South University