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

Leukemia, Lymphoid Clinical Trial

Official title:

Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111625
• Other study ID #: Blin-bridge 1.0
• Status: Recruiting
• Phase: Phase 2
• Start date: September 10, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression free survival of this group of patients at the end of 2 years	2 years
Secondary	Overall survival (OS)	Overall survival of this group of patients at the end of 2 years	2 years
Secondary	Relapse rate	Relapse rate of this group of patients at the end of 2 years	2 years
Secondary	Cumulative incidence of acute graft versus host disease (aGVHD)	Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100	Day +100
Secondary	Cumulative incidence of chronic graft versus host disease (cGVHD)	Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 years	2 years