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Blinatumomab bridging therapy in high-risk B-Acute Lymphoblastic Leukemia - phase 2 study
Children’s Wisconsin is currently enrolling patients up to 25 years old on a phase 2 study using blinatumomab as a bridging therapy to stem cell transplant. Dr Michael Burke is the Primary Investigator and Study Chair. This study will be testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to stem cell transplant to improve post-transplant outcomes. We anticipate enrolling 35 participants in the next 3 years.
This study will determine the effectiveness of delivering 1 to 2 cycles of blinatumomab (Days 1-28) as bridging therapy in children, adolescent and young adults with relapse or persistent minimal residual disease (MRD) B-ALL. Eligible patients will receive 1 or 2, 28-day cycles of blinatumomab prior to proceeding to hematopoietic stem cell transplantation (HCT). Centralized MRD assessment will be performed after completion of the 28-days of blinatumomab using both flow cytometry (University of Washington, Brent Wood, MD) and High-Throughput Deep Sequencing (HTS) MRD technologies (Adaptive Technologies, Seattle, WA). Subjects who achieve flow cytometry negative MRD (<0.01%) after a single cycle of blinatumomab can proceed directly to HCT whereas subjects who remain MRD positive by flow cytometry may receive a 2nd cycle of blinatumomab. Subjects who remain MRD positive by flow cytometry after a 2nd cycle of blinatumomab will come off study.
ClinicalTrials.gov identifier (NCT number): NCT04556084
For more information contact: Amberley Kemic | Clinical Research RN | 414-266-2038
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"The steady improvement in survival for children with cancer is a direct result of their enrollment onto clinical trials; without which we would remain decades behind in terms of scientific advances in pediatric cancer." ~Michael J. Burke, MD