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Trial Title:
Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
NCT ID:
NCT06111625
Condition:
Leukemia, Lymphoid
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
blinatumomab
Description:
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.
Arm group label:
blinatumomab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Ji, MD
Phone:
86-28-85422370
Email:
jieji@scu.edu.cn
Start date:
September 10, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06111625
