Azacitidine & Combo Chemo in Treating Infants W/ALL & KMT2A

A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A(MLL) Gene Rearrangement

January 17, 2018

  • Clinical Trial Information

    Trial Contact: Leffin, Melissa; El-Shami, Jessica; Francois, Laetitia Claire; Spinelli, Jennifer

  • IRB No: AALL15P1

    Protocol Abbrev: AALL15P1

    Principal Investigator: Vincent F. Giusti, MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: AALL15P1

    Treatment: azacitidine, combination chemotherapy

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT02828358

  • Objective

    This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.

  • Key Eligibility

    Inclusion Criteria:
    •  Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic
    •  Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment

    Exclusion Criteria:
    •  Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
    •  Patients with Down syndrome
    •  Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
    •  With the exception of steroid pretreatment or the administration of intrathecal methotrexate per protocol dosing, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1