Leukemia, Lymphoid
Conditions
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.
Interventions
DRUGblinatumomab
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.
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. patients diagnosed with B-ALL; 2. patients with age ≥ 16 years; 3. Availability of both pre- and post-transplantation disease status records.
Exclusion criteria
1. administration of blinatumomab therapy for more than 14 days; 2. patients with leukemia burden ≥ 10% before initiation of treatment; 3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction; 4. patients with central nervous system leukemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | Progression free survival of this group of patients at the end of 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed