Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Inclusion Criteria:

REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

   - Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO
   criteria) are eligible. Patients with Burkitt type ALL are NOT eligible

   - Patients who have BCR-ABL fusion transcript determined by fluorescence in situ
   hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or
   t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for
   enrollment on studies that incorporate imatinib during induction; please note: flow
   cytometry is to be performed at the local reference lab and must include assessment of
   CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity

   - No prior therapy except for limited treatment (< 7 days) with corticosteroids or
   hydroxyurea and a single dose of intrathecal cytarabine

   - No prior therapy for acute leukemia except emergency therapy (corticosteroids or
   hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due
   to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange
   transfusion is recommended to reduce the WBC

   - Single-dose intrathecal cytarabine is allowed prior to registration or prior to
   initiation of systematic therapy for patient convenience; systemic chemotherapy must
   begin within 72 hours of this intrathecal therapy

   - Patients receiving prior steroid therapy are eligible for study; the dose and duration
   of previous steroid therapy should be carefully documented on case report forms

   - Not pregnant and not nursing; for women of childbearing potential only, a negative
   urine or serum pregnancy test done =< 7 days prior to registration is required

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

   - Patients with down syndrome are excluded from this study

   - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of
   normal (ULN), unless suspected leukemic involvement of the liver

   - Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic
   involvement of the liver

   - Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault

RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)

   - Completion of remission induction therapy

   - Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater
   than 25% lymphoblasts) will not be eligible to be randomized

      - Rating: M0, M1; Blast Cells (%): 0-5.0

      - Rating: M2; Blast Cells (%): 5.1-25.0

      - Rating: M3; Blast Cells (%): > 25-50

      - Rating: M4; Blast Cells (%): > 50.0

      - The term "blast cell" includes any cell that cannot be classified as a more
      mature normal element, and includes "leukemic cells," pathologic lymphocytes, and
      stem cells

   - No ascites, effusions or significant edema

   - Absolute neutrophil count (ANC) >= 1,000/mm^3

   - Platelet count >= 100,000/mm^3

   - Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known
   Gilbert's syndrome

   - Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

   - Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V)

   - Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy
   (Course V)

   - Patient is in complete continuous first remission at entry into A041501-HO1

   - Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of
   therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75
   mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX
   dosing based on laboratory or clinical parameters is acceptable)

   - Patient is able and willing to use the Medication Event Monitoring System (MEMS)
   TrackCap (e.g. not using a pillbox)