Laboratory-Treated T-Cells in Treating Patients With Chemotherapy-Resistant or Refractory B-Cell Acute Lymphoblastic Leukemia

Inclusion Criteria

• Signed informed consent form must be obtained prior to any study procedure
• Relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) * 1st or greater bone marrow (BM) relapse OR * Any marrow relapse after allogeneic hematopoietic stem cell transplant (HSCT) and > 100 days from transplant OR * For patients with refractory disease: ** < 60 years old that have not achieved a CR after >= 2 or more chemotherapy regimens ** >= 60 years old that have not achieved a CR after 1 prior chemotherapy regimen ** Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they have failed tyrosine kinase inhibitor therapy
• Creatinine =< 1.6 mg/dl
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x upper limit of normal range
• Direct bilirubin =< 2.0 mg/dl
• Must have a minimum level of pulmonary reserve defined as =< grade 1 dyspnea and pulse oxygen > 92% on room air
• Left ventricle ejection fraction (LVEF) >= 40% confirmed by echocardiogram (ECHO)/multi gated acquisition (MUGA) scan
• Bone marrow with >= 5% lymphoblasts
• Life expectancy > 12 weeks
• An Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1
• No contraindications for leukapheresis

Exclusion Criteria

• Isolated extra-medullary disease relapse
• Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
• Uncontrolled active hepatitis B or active hepatitis C
• Human immunodeficiency virus (HIV) infection
• Active acute or chronic graft-versus-host disease (GVHD)
• Concurrent use of systemic steroids or immunosuppressant medications
• Active central nervous system (CNS) involvement by malignancy; Note: Patients with history of CNS disease that has been effectively treated will be eligible provided that treatment was > 4 weeks before enrollment
• Pregnant or nursing (lactating) women, female study participants of reproductive potential must have a negative serum or urine pregnancy test within 48 hours before infusion
• Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation