drugset / Trial / NCT04604691

Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD)

NCT04604691

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.

Timeline

Start
2022-02-18
Primary completion
2023-03
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody Intravenous