Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Condition: Acute Lymphoblastic Leukemia; Adult Acute Lymphoblastic Leukemia in Complete Remission; Burkitt Leukemia; Burkitt Lymphoma; CD20 Positive; Childhood Acute Lymphoblastic Leukemia in Complete Remission; Lymphoblastic Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Methotrexate; Ofatumumab; Vincristine Sulfate
Intervention description: Given IV; Given IV; Given IV or PO; Given IV; Correlative studies; Given IV; Given IV; Given IV
Intervention MeSH terms: Cytarabine; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Ofatumumab; Antibodies, Monoclonal; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy and ofatumumab work in treating
      patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in
      chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and
      dexamethasone, 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. Immunotherapy
      with ofatumumab, may induce changes in body's immune system and may interfere with the
      ability of tumor cells to grow and spread. Giving combination chemotherapy together with
      ofatumumab may be an effective treatment for acute lymphoblastic leukemia or lymphoblastic
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of all ages with newly diagnosed, previously untreated CD-20+ acute
             lymphoblastic leukemia (ALL), or lymphoblastic lymphoma, Burkitt leukemia/lymphoma or
             having achieved complete remission (CR) with one course of induction chemotherapy

          -  Failure to one induction course of chemotherapy (these patients will be analyzed
             separately)

          -  Performance status of 0, 1, or 2

          -  Creatinine less than or equal to 3.0 mg/dL (unless considered tumor related)

          -  Bilirubin less than or equal to 3.0 mg/dL (unless considered tumor related)

          -  Adequate cardiac function defined as no clinically significant history of arrhythmia
             as determined by the principal investigator (PI) and/or the treating physician,
             history of myocardial infarction (MI) or clinically significant abnormal
             electrocardiogram (EKG), as determined by the PI and/or the treating physician, within
             3 months prior to study enrollment; cardiac function will be assessed by history and
             physical examination

          -  No active or co-existing malignancy (other than ALL or lymphoblastic lymphoma) with
             life expectancy less than 12 months due to that malignancy

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Known to be human immunodeficiency virus positive (HIV+)

          -  Philadelphia chromosome (Ph)+ 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 metastases or stable
             chronic liver disease per investigator assessment)

          -  Treatment with any known non-marketed drug substance or experimental therapy within 5
             terminal half-lives (calculated by multiplying the reported terminal half-life by 5)
             or 4 weeks prior to enrollment, whichever is longer, or currently participating in any
             other interventional clinical study

          -  History of significant cerebrovascular disease in the past 6 months or ongoing event
             with active symptoms or sequelae

          -  Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B
             surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core
             antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid
             (DNA) test will be performed and if positive the subject will be excluded; consult
             with a physician experienced in care & management of subjects with hepatitis B to
             manage/treat subjects who are anti-HBc positive

          -  Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C
             antibody (HCAb), in which case reflexively perform a HC radioimmunoblotting assay
             (RIBA) immunoblot assay on the same sample to confirm the result