Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
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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