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

NCT06111625 | Recruiting Phase 2

• 1 other identifier: Blin-bridge 1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Lymphoid

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival of this group of patients at the end of 2 years

  2 years

Secondary Outcomes (4)

• Overall survival (OS)

  2 years

• Relapse rate

  2 years

• Cumulative incidence of acute graft versus host disease (aGVHD)

  Day +100

• Cumulative incidence of chronic graft versus host disease (cGVHD)

  2 years

Study Arms (1)

blinatumomab

EXPERIMENTAL

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.

Drug: blinatumomab

Interventions

blinatumomab DRUG

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.

blinatumomab

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with B-ALL;
• patients with age ≥ 16 years;
• Availability of both pre- and post-transplantation disease status records.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: September 10, 2023
• Primary Completion: August 31, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)