This study is a single center, single arm, prospective, phase II clinical study to evaluate the efficacy and safety of Venatoclax combined with reduced intensity conditioning regimen allo-HSCT in the treatment of high-risk myeloid malignancies in the elderly patients.
Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d\~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d\~-2d (5d), Cytarabine: 1g/m2/d, - 6d\~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d\~-5d (2d), total body irradiation(TBI): 3 Gray, - 1d. Primary end point: 1 year and 2 year progression free survival (PFS) after transplantation. Secondary end point: incidence of acute GVHD within 180 days after transplantation; cumulative rate of relapse, overall survival(OS), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), non-relapse mortality(NRM), and incidence of chronic GVHD at 1 and 2 years after transplantation; The reactivation rate of cytomegalovirus(CMV) and Epstein-Barr virus (EBV) within 1 year after transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Eligible patients will receive Venetoclax plus RIC regimen allogeneic transplantation. The treatment regimen is: Venetoclax 100mg/d - 10d, 200mg/d - 9d (first use and NR or untreated MDS), 400mg/d, - 8d\~ - 2d (7d); Fludarabine: 30mg/m2/d, - 6d\~-2d (5d), Cytarabine: 1g/m2/d, - 6d\~-2d (5d) Busulfan: 3.2mg/m2/d, - 6d\~-5d (2d), TBI: 3 Gray, - 1d.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPFS
Progression free survival for all patients enrolled
Time frame: 1- year PFS
PFS
Progression free survival for all patients enrolled
Time frame: 2- year PFS
OS
Overall survival for all patients enrolled
Time frame: 1- year OS
OS
Overall survival for all patients enrolled
Time frame: 2- year OS
aGVHD rate
The incidence rate of acute GVHD after transplantation
Time frame: 180 days after transplantation
cGVHD rate
The incidence rate of chronic GVHD after transplantation
Time frame: 1 year after transplantation
cGVHD rate
The incidence rate of chronic GVHD after transplantation
Time frame: 2 years after transplantation
Relapse rate
Cumulative relapse rate after transplantation
Time frame: 1 year after transplantation
NRM
Non relapse mortality after transplantation
Time frame: 2 years after transplantation
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GVHD-free relapse-free survival(GRFS)
Time from transplantation to the diagnosis of chronic GVHD or relapse
Time frame: 2 years after transplantation
Reactivation rate of EBV and CMV
Reactivation rate of Epstein-Barr virus and cytomegalovirus after transplantation
Time frame: 1 year after transplantation
Reactivation rate of EBV and CMV
Reactivation rate of Epstein-Barr virus and cytomegalovirus after transplantation
Time frame: 2 years after transplantation