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A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
AALL2321
What is the goal of the study?
To evaluate the safety and tolerability of venetoclax in addition to a standard chemotherapy backbone and two cycles of blinatumomab in infants (aged 365 days or less at diagnosis) with newly diagnosed KMT2A-R ALL. 1.1.2 To determine in a randomized manner if the addition of venetoclax to Induction chemotherapy improves end of Induction minimal residual disease (MRD)- negative remission rates in infants with KMT2A-R ALL.
Who can participate in the study?
Patient 365 days old or younger