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

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• Patient with active heart disease (NYHA class > 3 as assessed by history and physical examination).
• Patients with active hepatitis are excluded.

Laborértékek

• Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 40% are excluded.

Egyéb

• Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
• Pregnant or breast-feeding women are excluded.

• 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.
• 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.
  • These patients are defined as having at least one of the below comorbidities:
  • ECOG performance status ≥ 2
  • Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
  • Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)
  • Creatinine clearance < 45 mL/min, and
  • Hepatic disorder with total bilirubin > 1.5 x upper limit of normal
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  • If they achieved CR, they are assessable only for event-free and overall survival, or
  • If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
• 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.
• Zubrod performance status 0-3.
• 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.
• Provision of written informed consent.
• Patients in first remission are eligible.
• 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.