A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Inclusion Criteria:

• Male or female participants, age 18 years or older at screening.

• Relapsed or refractory CD22-positive ALL.

• Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standardtreatment with at least one tyrosine kinase inhibitor.

• Patients in Salvage 1 with late relapse should be deemed poor candidates forreinduction with initial therapy.

• Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts bymorphologic assessment.

• ECOG performance status 0-2.

• Adequate renal and hepatic function, and negative pregnancy test for women ofchildbearing potential.

Exclusion Criteria:

• Subjects with isolated extramedullary relapse or active central nervous system (CNS)leukemia.

• Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22immunotherapy within 4 months, or active graft versus host disease (GvHD) at studyentry.

• Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstructionsyndrome (SOS).