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- Pediatric Patients with High-Risk B-Cell ALL in First Complete . . .
Background: One of the key questions in trial AIEOP-BFM ALL 2017 focused on the reduction of treatment-related complications by replacing parts of the highly intensive consolidation phase by two courses of Blinatumomab (Blina) in a prospective randomized trial
- Protocol - The New England Journal of Medicine
Study Design: This is a phase 3 randomized, open label study designed to evaluate the efficacy of blinatumomab versus investigator choice of SOC chemotherapy
- Summary Table of Study Protocol
The primary study period is planned from July 2017 through September 30, 2024 Index date of transplant for patient identification will be between July 2017 through May 31, 2022 which will allow for each patient to have at least 3 years of potential follow-up
- ClinicalTrials. gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information
- The safety of blinatumomab in pediatric patients with acute . . .
Background: Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
- Blinatumomab as postremission therapy replaces consolidation and . . .
Here, we report the efficacy of a single course of blinatumomab instead of consolidation chemotherapy to eliminate minimal residual disease (MRD) and maintain stable MRD-negativity in children with primary BCP-ALL
- AIEOP-BFM ALL 2017 - amgen-oncology. at
If upcoming analyses of outcome data in trial AIEOP-BFM ALL 2017 will not show any inferiority of the EA in terms of anti-leukemia efficacy, blinatumomab replacement of some of the intensive chemotherapy blocks will become the new standard of care for treatment in newly diagnosed patients with HR B-ALL
- Blinatumomab is changing the standard of care paradigms of newly . . .
The AIEOP-BFM ALL 2017 trial (NCT03643276) was the first randomized phase III trial to evaluate a multi-agent chemotherapy regimen without or with the addition of blinatumomab in children with newly diagnosed intermediate-risk B‑ALL patients
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