Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
Condition: Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Acute Disease
Intervention: Azacitidine; Cyclophosphamide; Cytarabine; Daunorubicin; Daunorubicin Hydrochloride; Dexamethasone; Hydrocortisone Sodium Succinate; Laboratory Biomarker Analysis; Leucovorin; Leucovorin Calcium; Mercaptopurine; Methotrexate; Pegaspargase; Pharmacological Study; Prednisolone; Thioguanine; Vincristine; Vincristine Sulfate
Intervention description: Given IV; Given IV; Given IV, SC, IT; Given IV; Given IV; Given PO, NG, IV; Given IT; Correlative studies; Given PO, IV; Given PO, IV; Given PO, NG; Given IT, IV, PO; Given IV; Correlative studies; Given PO, NG; Given PO, NG; Given IV; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cortisone; Cyclophosphamide; Methotrexate; Vincristine; Azacitidine; Daunorubicin; Asparaginase; Mercaptopurine; Pegaspargase; Thioguanine; Prednisolone hemisuccinate; Prednisolone phosphate; BB 1101; Calcium; 2-Aminopurine; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Maximum age: 364 Days
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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