Status:
UNKNOWN
Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fl...
Detailed Description
In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feas...
Eligibility Criteria
Inclusion
- refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
- patients with HLA matched related or unrelated donor (9\~10/10) or haplo-identical related donor
Exclusion
- Patients with poor liver function (enzyme \>2N or bilirubin \>2N)
- poor renal function (Scr \>1.5N)
- poor cardiac function （EF\<45%）
- inform consent not provided
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04904237
Start Date
January 1 2021
End Date
June 1 2024
Last Update
June 1 2021
Active Locations (3)
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1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, China, 200025
2
Department of Hematology, Shanghai No6 Hospital
Shanghai, China
3
Shanghai ZhaXin Hospital
Shanghai, China