Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Inclusion Criteria

• Signed informed consent.
• Age ≥ 18 years.
• Subject with CD19-expressing B-ALL.
• Adequate organ function.
• Patients considered in any of the following settings are eligible:
• Untreated first or second relapse
• Refractory to primary induction therapy
• Refractory to first salvage therapy or
• Relapse after allogenic stem cell transplant.

Exclusion Criteria

• Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis
• Presence of extra-medullary disease.
• History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.
• History of Veno-occlusive Disease (VOD).
• Active neurological autoimmune or inflammatory disorders.
• Active acute Graft-versus-Host Disease (GvHD), grade 2-4. Other protocol-defined Inclusion/Exclusion may apply.