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NCT Number: NCT06111625

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

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.

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Key information

Conditions

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

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location status: Recruiting

Location contact

Jie Ji, MD

CONTACT

[email protected]

86-28-85422370

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 2 years

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

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 2 years

    Overall survival of this group of patients at the end of 2 years

  2. Relapse rate

    Time frame: 2 years

    Relapse rate of this group of patients at the end of 2 years

  3. Cumulative incidence of acute graft versus host disease (aGVHD)

    Time frame: Day +100

    Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100

  4. Cumulative incidence of chronic graft versus host disease (cGVHD)

    Time frame: 2 years

    Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 years

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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