T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Exclusion Criteria

• •Karnofsky/Lansky performance status \<60.
• •Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
• •Patients with active HIV, hepatitis B or hepatitis C infection.
• •Females who are pregnant
• •Karnofsky/Lansky performance status \<60.
• •Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
• •Patients will be excluded if they have isolated extra-medullary relapse of ALL
• •Females who are pregnant.
• •Patients with active (grade 2-4) acute graft versus host disease (GVHD), chronic GVHD or an overt autoimmune disease (e.g. hemolytic anemia) following allo-HSCT requiring glucocorticosteroid treatment (\>0.5 mg/kg/day prednisone or its equivalent) as treatment.
• •Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) within 7 days of treatment or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of treatment. Prophylactic intrathecal medication is not a reason for exclusion.
• •o If the LP is traumatic (containing RBCs) and cannot be repeated the Steinherz/Bleyer ratio will be used to determined unequivocal evidence of CSF leukemia at the discretion of the treating physician.
• •Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the treating investigator would pose an unacceptable risk to the subject.
• •Prior neurologic toxicity to previous immunotherapy
• •Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patient's ability to endure known side effects of cytokine release syndrome or neurologic toxicity
• •Recent prior therapy: Systemic chemotherapy less than 2 weeks prior to infusion or apheresis (6 weeks for clofarabine or nitrosoureas for apheresis) or radiation therapy less than or equal to 3 weeks prior to apheresis. Exceptions:
• •oThere is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such.
• •oSubjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment.
• •oSubjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment.
• •oSubjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met. Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
• •Rapidly progressive disease that in the estimation of the treating physician would compromise ability to complete study therapy.