This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Blinatumomab will be administered as a continuous intravenous (CIV) infusion at a constant flow rate over four weeks followed by a two-week infusion free interval.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGSafety evaluation including cytokine release syndrome
The incidence of treatment-emergent and treatment-related adverse events
Time frame: At the latest possible timepoint prior to the initiation of transplant conditioning or after 30 days of Blinatumomab treatment
Complete MRD response status after 1 cycle of blinatumomab
Time frame: 28 Days
Hematologic Relapse-Free Survival (RFS)
Time frame: 24 Months
Overall Survival (OS)
Time frame: 24 Months
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