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

This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.

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 standard treatment with at least one tyrosine kinase inhibitor.Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.ECOG performance status 0-2.Adequate renal and hepatic function, and negative pregnancy test for women of childbearing 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-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).