Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement


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Trial ID: NCT02828358


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.

Official Title

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

Stanford Investigator(s)


Inclusion Criteria:

   - Infants must be > 36 weeks gestational age at the time of enrollment

   - 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 or intrathecal cytarabine, 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


drug: Azacitidine

drug: Cyclophosphamide

drug: Cytarabine

drug: Daunorubicin Hydrochloride

drug: Dexamethasone

drug: Hydrocortisone Sodium Succinate

other: Laboratory Biomarker Analysis

drug: Leucovorin Calcium

drug: Mercaptopurine

drug: Methotrexate

drug: Pegaspargase

other: Pharmacological Study

drug: Prednisolone

drug: Thioguanine

drug: Vincristine Sulfate

drug: Daunorubicin

drug: Leucovorin

drug: Vincristine


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nancy Sweeters

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