A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab
This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGProgress-Free Survival
Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.
Time frame: At Year 1
Overall Survival
Overall survival (OS) is defined as the time from transplantation to death
Time frame: At Year 1
Cumulative Incidence of Relapse
The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
Time frame: At Year 1
Non-relapse Mortality
NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy.
Time frame: At Year 1
Minimal Residual Disease
Minimal residual disease is a small number of cancer cells left in the body after treatment.
Time frame: At Year 1
acute graft versus host disease
assessment of acute GVHD
Time frame: At Day 100
chornic graft versus host disease
assessment of chronic GVHD
Time frame: At Year 1
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