This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.
This study is a single-center, prospective, single-arm Phase I clinical trial. Since July 2023, 12 patients with high-risk acute B-lymphoblastic leukemia who underwent allogeneic hematopoietic stem cell transplantation were enrolled at the Department of Hematology, the PLA General Hospital . Patients were enrolled after 45d for MSD-HSCT, and after 60d for URD/Haplo donor-HSCT. The maintenance regimen combined blinatumomab (9 µg/day × 7 days) and donor lymphocyte infusion (DLI, CD3+ cells 1× 10⁵/kg). The first cycle was given within the first 3 months after allogeneic HCT and then at approximately 6, 9, and 12 months following transplant. The safety and efficacy of this regimen were analyzed. Patients were premedicated with dexamethasone prior to the start of each cycle. The study was approved by the Ethics Committee of the PLA General Hospital.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
blinatumomab 9ug d1-7, 28ug d8-14
CD3+cell 1×10\^5/kg
Chinese PLA General Hospital
Beijing, China
RECRUITING1 year progression-free-survival
the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.
Time frame: 1 year
1 year aGVHD rate
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) The cumulative incidences of aGvHD was defined as the number and the ratio of the participants with aGVHD.
Time frame: 100 days after transplantation
1 year cGVHD rate
Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) cGvHD was diagnosed and graded according to the 2014 National Institutes of Health (NIH) consensus criteria: mild, moderate or severe respectively.
Time frame: 365 days after transplantation
Nonrelapse mortality (NRM)
Defined as the proportion of subjects who died due to causes other than malignancy relapse
Time frame: 365 days after transplantation
Overall survival (OS)
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause
Time frame: 365 days after transplantation
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