logo Hematology/Oncology Research Studies: Open for Enrollment Date: 10/22/18

Category: ONCOLOGY: EARLY PHASE

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