Key inclusion criteria:

          -  Signed informed consent/assent must be obtained for this study prior to participation
             in the study.

          -  Patients for whom the final manufactured tisagenlecleucel product does not meet the
             commercial release specifications.

          -  Not excluded from commercial manufacturing under the Health Authority-approved
             tisagenlecleucel prescribing information for their respective country/region.

          -  OOS material has not been deemed to pose an undue safety risk to the patient.

          -  Patient is suffering from a serious or life-threatening disease or condition.

          -  Repeat leukapheresis is not clinically appropriate per the investigator assessment.

        Key exclusion criteria:

          -  Patients meeting any of the following criteria are not eligible for inclusion in this
             study:

          -  Human immunodeficience virus (HIV) positive patients.

          -  Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus
             (HCV).

          -  Patients with primary central nervous system (CNS) lymphoma.

          -  History of hypersensitivity to any drugs or metabolites of similar chemical classes as
             tisagenlecleucel.

          -  Uncontrolled active infection or inflammation.

          -  Any medical condition identified by the investigator that may impact the assessment of
             the safety or efficacy outcomes in relation to study treatment.

          -  Pregnant or nursing (lactating) women.