The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Time frame: 2 years
100 day adverse events (AE)
non-hematologic adverse events
Time frame: Day +100
Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 month
Time frame: 6 months
Relapse rate
Relapse rate of this group of patients at the end of 2 year
Time frame: 2 years
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Time frame: 2 years
Cumulative incidence of acute graft versus host disease (aGVHD)
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time frame: Day +100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.