Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

Phase 2

Recruiting

• Conditions: Leukemia, Lymphoid
• Interventions: Drug: blinatumomab

• Registration Number: NCT06111625
• Lead Sponsor: Sichuan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blinatumomab	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years	Progression free survival of this group of patients at the end of 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China