Status:
RECRUITING
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Acute Lymphoblastic Leukemia
Measurable Residual Disease (MRD)
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06886074
Start Date
January 2 2025
End Date
June 1 2027
Last Update
March 20 2025
Active Locations (1)
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1
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460