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Venetoclax and Decitabin Based Conditioning Regimen Followed With Post-HSCT Decitabin Maintenance Therapy in TP53 Mutant AML/MDS Patients
Sponsor: Zhejiang University
Summary
This study aims to evaluate the effectiveness and safety of Venetoclax and Decitabin based conditioning regimen followed with post-HSCT Decitabin maintenance therapy in TP53 mutant AML/MDS Patients.
Key Details
Gender
All
Age Range
12 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2022-06-02
Completion Date
2026-03-31
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
VEN and DEC based conditioning regimen
For human leukocyte antigen (HLA) matched-donor transplantation, the regimen consisted of venetoclax 400 mg once daily on days -12 to -6, decitabine 20 mg/m² once daily on days -12 to -8, busulfan 0.8 mg/kg every 6 h on days -7 to -4, cyclophosphamide 60 mg/kg once daily on days -3 to -2, and semustine 250 mg/m² on day -1. For haploidentical HCT, the regimen consisted of venetoclax 400 mg once daily on days -14 to -8, decitabine 20 mg/m² once daily on days -14 to -10, cytarabine 2 g/m² once daily on days -9 to -8, busulfan 0.8 mg/kg every 6 h on days -7 to -5, cyclophosphamide 1.8 g/m² once daily on days -4 to -3, and semustine 250 mg/m² on day -2. Patients aged ≥50 years or with an HCT-CI score ≥3 received reduced-toxicity conditioning (RTC), consisting of venetoclax 400 mg once daily on days -12 to -6, decitabine 20 mg/m² once daily on days -12 to -8, fludarabine 30 mg/m² once daily on days -7 to -3, busulfan 0.8 mg/kg every 6 h on days -7 to -5, and semustine 250 mg/m² on day -2.
DEC
In the time window of 60-120 days after transplantation: DEC 5mg/m2/d for 5 consecutive days every 6 to 8 weeks with a total of 6 courses if there is no severe aGVHD (grade 3 or higher) and the donor chimerism rate of bone marrow blood (STR)\>95%. If the MRD turns positive, DLI can be performed.
Locations (4)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliate Hospital of Nanchang University, Nanchang
Nanchang, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China