Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia in Remission; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Philadelphia Chromosome
Intervention: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Inotuzumab Ozogamicin; Laboratory Biomarker Analysis; Leucovorin Calcium; Mercaptopurine; Methotrexate; Ofatumumab; Prednisone; Rituximab; Vincristine Sulfate
Intervention description: Given IV; Given IT or IV; Given IV or PO; Given IV; Given IV; Correlative studies; Given IV; Given PO; Given IT, IV or PO; Given IV; Given PO; Given IV; Given IV
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Cytarabine; Dexamethasone; Prednisone; Dexamethasone acetate; Cortisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Mercaptopurine; Ofatumumab; Inotuzumab Ozogamicin; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal; BB 1101; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work
      in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as
      cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate
      and cytarabine, work in different ways to stop the growth of tumor cells, either by killing
      the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy
      with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system
      attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
      Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute
      lymphoblastic leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed, previously untreated B-lineage ALL, or having achieved
             complete remission (CR) with one course of induction chemotherapy

          -  Patients with extramedullary disease only are eligible

          -  Failure to one induction course of chemotherapy (these patients will be analyzed
             separately)

          -  Performance status of 0-3

          -  Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)

          -  Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)

          -  Adequate cardiac function as assessed by history and physical examination

          -  No active or co-existing malignancy with life expectancy less than 12 months

          -  Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP
             must agree to use contraception during the study, if sexually active

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Known to be human immunodeficiency virus (HIV)-positive

          -  Philadelphia chromosome (Ph)-positive ALL

          -  Active and uncontrolled disease/infection as judged by the treating physician

          -  Unable or unwilling to sign the consent form

          -  Subjects who have current active hepatic or biliary disease (with exception of
             patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable
             chronic liver disease per investigator assessment)

          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
             antiviral treatment such as, but not limited to, chronic renal infection, chronic
             chest infection with bronchiectasis, tuberculosis and active hepatitis C