Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blinatumomab.
- Who it may be relevant to
- Registry conditions: Leukemia, Lymphoid. Basic parameters: 16 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden
Overview
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.
Interventions
- Drug blinatumomab
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.
Primary outcome measures
- Progression free survival (PFS) [Time frame: 2 years]
Secondary outcome measures (4)
- Overall survival (OS) [Time frame: 2 years]
- Relapse rate [Time frame: 2 years]
- Cumulative incidence of acute graft versus host disease (aGVHD) [Time frame: Day +100]
- Cumulative incidence of chronic graft versus host disease (cGVHD) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- patients diagnosed with B-ALL;
- patients with age ≥ 16 years;
- Availability of both pre- and post-transplantation disease status records.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT06111625 · Blin-bridge 1.0