Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. Patients underwent myeloablative conditioning therapy consisting of fludarabine-and-busulfan-based regimen. Peripheral stem cells from HLA-matched sibling donors (MSD), matched unrelated donors (MUD), or haploidentical donors (HID) were reinfused two days after conditioning. Follow-up examinations were scheduled at +1, +2, +3, +4, +6, +9, +12, +18, and +24 months post-transplant. |
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.
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [2 years]
Progression free survival of this group of patients at the end of 2 years
Secondary Outcome Measures
- Overall survival (OS) [2 years]
Overall survival of this group of patients at the end of 2 years
- Relapse rate [2 years]
Relapse rate of this group of patients at the end of 2 years
- Cumulative incidence of acute graft versus host disease (aGVHD) [Day +100]
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
- Cumulative incidence of chronic graft versus host disease (cGVHD) [2 years]
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 years
Eligibility Criteria
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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610044 |
Sponsors and Collaborators
- Sichuan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Blin-bridge 1.0