RecruitingPhase 2NCT06886074

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

Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia


Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Enrollment

30 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 60 Years

Inclusion Criteria5

  • Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
  • MRD detectable in complete response (above the limit of quantification according to FCM)
  • Performance status 0-2 on the ECOG scale
  • No prior organ damage
  • Having a potential related or unrelated donor

Exclusion Criteria7

  • 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

Interventions

DRUGShort course of blinatumomab

Patients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion. Blinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose.


Locations(1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, Mexico

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NCT06886074


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