Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden
Sichuan University
20 participants
Sep 10, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.
Eligibility
Inclusion Criteria3
- patients diagnosed with B-ALL;
- patients with age ≥ 16 years;
- Availability of both pre- and post-transplantation disease status records.
Exclusion Criteria4
- administration of blinatumomab therapy for more than 14 days;
- patients with leukemia burden ≥ 10% before initiation of treatment;
- patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;
- patients with central nervous system leukemia.
Interventions
Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06111625