Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL

Last updated: March 18, 2025
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoproliferative Disorders

Platelet Disorders

Leukemia

Treatment

Short course of blinatumomab

Clinical Study ID

NCT06886074
HE25-00007
  • Ages 16-60
  • All Genders

Study Summary

Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT

Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia

  • MRD detectable in complete response (above the limit of quantification according toFCM)

  • Performance status 0-2 on the ECOG scale

  • No prior organ damage

  • Having a potential related or unrelated donor

Exclusion

Exclusion Criteria:

  • Performance status on the ECOG scale >2

  • HCT-CI >3 points

  • Patients who do not wish to participate in clinical study.

  • Active central nervous system infiltration (CNS3)

  • Active extramedullary disease

  • Having previously received blinatumomab

  • Absence of related or unrelated donors

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Short course of blinatumomab
Phase: 2
Study Start date:
January 02, 2025
Estimated Completion Date:
June 30, 2027

Study Description

During the proposed treatment, blinatumomab therapy will be assigned as follows:

Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.

The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.

Connect with a study center

  • Hospital Universitario Dr. Jose E. Gonzalez

    Monterrey, Nuevo Leon 64460
    Mexico

    Active - Recruiting

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