AALL15P1, A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement
Study ID: STU 112017-024
infants with newly diagnosed B lymphoblastic leukemia or acute leukemia of ambiguous lineage will be treated with standard induction chemotherapy based on aaLL0631 induction, with pegaspargase. Following induction, infants with KMT2a-R will be non-randomly assigned to receive four courses of azacitidine therapy, as epigenetic priming, prior to each major block of post-induction chemotherapy. infants with KMT2a germline (non-rearranged) leukemia will not receive azacitidine and will be removed from protocol therapy following remission assessment at the completion of induction.