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

• Status: Not yet recruiting
• Trial end date: 2026-05-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Inotuzumab Ozogamicin

Criteria

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).