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<p><strong>Primary Objective</strong>: To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments</p>
<p><strong>Secondary Objective(s)</strong>: To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT.</p>
<p><strong>Hypotheses</strong>: A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated.</p>
<p><strong>Study Endpoints</strong>: – Incidence of treatment-emergent and treatment-related adverse events – Incidence of CR within 2 cycles of blinatumomab – MRD remission within 2 cycles of blinatumomab – RFS – OS – Incidence of alloHSCT – 100-day mortality after alloHSCT</p>
<p><strong>Study Design</strong>: Multi-center, open-label, single-arm expanded access protocol</p>