To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Blinatumomab will be bridged to conventional BUCY conditioning regimen.
Control group will be given conventional BUCY conditioning regimen.
The first affiliated hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall survival (OS)
The time from randomization to death from any cause.
Time frame: From the 1st day to the 720th days after enrollment.
The proportion of patients with negative minimal residual disease (MRD)
Negative MRD is defined as below 10-4 by flow cytometry.
Time frame: From the 1st day to the 720th days after enrollment.
Progression-Free Survival (PFS)
It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.
Time frame: From the 1st day to the 720th days after enrollment.
Cumulative incidence of relapse (CIR)
From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.
Time frame: From the 1st day to the 720th days after enrollment.
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