Actively Recruiting

Phase 2
Age: 16Years - 60Years
All Genders
NCT06886074

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

Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2025-03-20

30

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
  • Detectable measurable residual disease (MRD) in complete response above the limit of quantification
  • Performance status 0 to 2 on the ECOG scale
  • No previous organ damage
  • Having a potential related or unrelated donor for transplantation
Not Eligible

You will not qualify if you...

  • Performance status greater than 2 on the ECOG scale
  • Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) greater than 3 points
  • Patients who do not wish to participate in the clinical study
  • Active central nervous system infiltration (CNS3)
  • Active extramedullary disease
  • Previous treatment with blinatumomab
  • No related or unrelated donors available

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

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Research Team

A

Andres Gomez-De Leon, Professor of Hematology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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