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Protocol Summary


Protocol No.
PSCI-17-080
Prinicipal Investigator
McGregor, Lisa
Phase
Pilot
Age Group
Children
Scope
National
Secondary Protocol No.
AALL15P1
Title
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
Objective
Primary Aims
To evaluate the tolerability of azacitidine in addition to Interfant-06 standard chemotherapy in infants with newly diagnosed ALL with KMT2A gene rearrangement (KMT2A-R).

Secondary Aims
To evaluate the biologic activity of azacitidine by pharmacodynamic assessment of global DNA methylation in peripheral blood mononuclear cells (PBMCs) of infants treated with azacitidine.
Applicable Disease Sites
Leukemia, other
Status
Open
Participating Institutions
Hershey Medical Center