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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: blinatumomabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

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

Time frame
2 years

Secondary outcomes

1

Overall survival (OS)

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

Time frame
2 years
2

Relapse rate

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

Time frame
2 years
3

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

Time frame
Day +100
4

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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