Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Alemtuzumab; Allogeneic Hematopoietic Stem Cell Transplantation; Autologous Hematopoietic Stem Cell Transplantation; Cyclophosphamide; Cytarabine; Dasatinib; Daunorubicin Hydrochloride; Dexamethasone; Etoposide Phosphate; Filgrastim; Fludarabine Phosphate; In Vitro-Treated Peripheral Blood Stem Cell Transplantation; Laboratory Biomarker Analysis; Leucovorin Calcium; Melphalan; Mercaptopurine; Methotrexate; Pegfilgrastim; Pharmacological Study; Tacrolimus; Vincristine Sulfate
Intervention description: Given IV; Undergo peripheral blood allogeneic HCT; Undergo peripheral blood autologous HCT; Given IV; Given IV; Given PO; Given IV; Given PO or IV; Given IV; Given SC; Given IV; Undergo peripheral blood autologous or allogeneic HCT; Correlative studies; Given IV or PO; Given IV; Given PO; Given IT, IV, or PO; Given SC; Correlative studies; Given IV or PO; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Melphalan; Mechlorethamine; Nitrogen Mustard Compounds; Methotrexate; Fludarabine; Fludarabine phosphate; Etoposide; Vincristine; Daunorubicin; Dasatinib; Mercaptopurine; Alemtuzumab; Etoposide phosphate; Antineoplastic Agents, Immunological; Tacrolimus; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim; BB 1101; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II clinical trial studies how well dasatinib followed by stem cell transplant
      works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib
      may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
      Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by
      stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may
      interfere with the ability of cancer cells to grow and spread. Giving more than one drug
      (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more
      cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unequivocal histologic diagnosis of ALL

          -  Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or
             BCR-ABL positive status by molecular analysis (Q-PCR or fluorescent in situ
             hybridization [FISH]) in a Cruise Lines International Association (CLIA)-approved
             laboratory

          -  No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable
             time for the detection of t(9;22)(q34;q11) or BCR/ABL

          -  Non-pregnant and non-nursing; treatment under this protocol would expose an unborn
             child to significant risks; women and men of reproductive potential should agree to
             use an effective means of birth control and contraception should continue for three
             months after the last dose of dasatinib to allow complete clearance of drug and its
             principal metabolites from the body; in women of childbearing potential, a pregnancy
             test will be required at study entry

          -  Left ventricular ejection fraction >= lower limit of institutional normal

          -  No myocardial infarction within 6 months

          -  No ventricular tachyarrhythmia within 6 months

          -  No major conduction abnormality (unless a cardiac pacemaker is present)