This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.
The experimental group included high risk T-ALL/LBL patients after allo-HSCT, who received relapse prevention treatment with demethylating agents such as azacitidine or decitabine, combined with venetoclax. The historical control consisted of high-risk T-ALL/LBL patients who received allo-HSCT but did not receive any prophylactic treatment from multiple centers, and their basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data to compare the advantages and disadvantages of the experimental regimen with the control group. The primary endpoint was the relapse-free survival(RFS) rate after prophylaxis, while secondary endpoints included cumulative incidence of relapse (CIR), overall survival (OS), and the GVHD-relapse-free survival (GRFS). This study aims to provide a effective and safer prophylaxis treatment for high-risk T-LBL/ALL patients after all-HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
59
Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle
decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.
venetoclax, 400mg/d, days 1-7 of each 28-day cycle
Shanghai General Hospital
Shanghai, China
RECRUITINGRFS
1-year relapse-free survival
Time frame: 1 year
RFS
2-year relapse-free survival
Time frame: 2 year
CIR
1-year cumulative incidence of relapse
Time frame: 1 year
CIR
2-year cumulative incidence of relapse
Time frame: 2 year
OS
1-year overall survival
Time frame: 1 year
OS
2-year overall survival
Time frame: 2 year
GRFS
1-year graft-versus-host disease (GVHD)-free/relapse-free survival (GRFS) rates
Time frame: 1 year
GRFS
2-year graft-versus-host disease (GVHD)-free/relapse-free survival (GRFS) rates
Time frame: 2 year
cGVHD
1-year cumulative incidence of cGVHD
Time frame: 1 year
cGVHD
2-year cumulative incidence of cGVHD
Time frame: 2 year
adverse events
adverse events during research
Time frame: at the end of every cycle (each cycle is 28 days)
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