Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Eligibility Criteria

• 1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.
• 2. Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.
• 1. ECOG performance status ≥ 2
• 2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
• 3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)
• 4. Creatinine clearance \< 45 mL/min, and
• 5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal
• 1. If they achieved CR, they are assessable only for event-free and overall survival, or
• 2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
• 3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.
• 4. Zubrod performance status 0-3.
• 5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL.
• 6. Provision of written informed consent.
• 7. Patients in first remission are eligible.
• 8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.
• 1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
• 2. Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination).
• 3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded.
• 4. Patients with active hepatitis are excluded.
• 5. Pregnant or breast-feeding women are excluded.