logo Hematology/Oncology Research Studies: Open for Enrollment Date: 10/31/18


Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

NCT#/Phase: NCT02828358
Phase 2
IRB#: 2017-090
Description: This is a COG group-wide pilot study to evaluate the tolerability of azacitidine in addition to Interfant-06 standard chemotherapy in infants with newly diagnosed ALL with KMT2A gene rearrangement (MKT2A-R). Infants with newly diagnosed B lymphoblastic leukemia of ambiguous lineage will be treated with standard Induction chemotherapy on AALL0631; infants with KMT2A-R will be non-randomly assigned to receive 4 courses of azacitidine therapy; infants with KMT2A germiline will not receive azacitidine and be removed from protocol.
Inclusion: Individuals with newly diagnosed B lymphoblastic leukemia, also termed B-precursor acute lymphoblastic leukemia or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL) in infants less than 1 year of age.
Enrollment Status: Open for enrollment
Sponsor: Children's Oncology Group
Principal Investigator(s): Carla Golden, MD
Contact(s): Christine Ho (510-428-3885 x 2609)
Diane Olzewski (510-428-3885 x 3246)
Study Link: https://clinicaltrials.gov/ct2/show/NCT02828358

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000