Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
ConditionLeukemia, Lymphoid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorSichuan University
About this trial
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 criteria
Qualifiers
patients diagnosed with B-ALL;
patients with age ≥ 16 years;
Availability of both pre- and post-transplantation disease status records.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- blinatumomab
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov