drugset / Trial / NCT05687032

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

NCT05687032

Phase 4 Completed 44 enrolled Pfizer
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-24
Primary completion
2024-08-07
Completion
2025-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Inotuzumab Ozogamicin Monoclonal antibody 0.5 mg/m2 Intravenous