Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Burkitt-Like Lymphoma With 11q Aberration
About this trial
This is an interventional treatment trial for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Eligibility Criteria
Inclusion Criteria:
- Patients aged 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 tyrosine kinase inhibitors (TKIs) and still eligible; these patients are defined as having at least one of the below comorbidities:
- Eastern Cooperative Oncology Group (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., carbon monoxide diffusing capability test [DLCO] =< 65% or forced expiratory volume in 1 second [FEV1] =< 65%)
- Creatinine clearance < 45 mL/min, and
Hepatic disorder with total bilirubin > 1.5 x upper limit of normal
- If they achieved complete remission (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
- Zubrod performance status 0-3
- Bilirubin =< 1.95 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 3 x upper limit of normal (ULN) unless considered due to tumor
- Estimated creatinine clearance >= 50 mL/min/1.73 m^2
- 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 involvement of any age are eligible
Exclusion Criteria:
- Newly diagnosed Burkitt's leukemia or lymphoma, T-cell ALL or lymphoblastic lymphoma
- Patient with active heart disease (New York Heart Association [NYHA] class >= 3 as assessed by history and physical examination)
- Patients with a cardiac ejection fraction (as measured by either multigated acquisition scan [MUGA] or echocardiogram) < 40% are excluded
- Patients with active hepatitis are excluded
- Pregnant or breast-feeding women are excluded
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (inotuzumab ozogamicin, combination chemotherapy)
Arm II (inotuzumab ozogamicin, combination chemotherapy)
Arm III (inotuzumab ozogamicin, combination chemotherapy)
See Detailed Description Arm I
See Detailed Description Arm II
See Detailed Description Arm III