At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 44 enrolled
Drug / intervention
inotuzumab ozogamicindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
In Brief
A Phase 4 clinical trial evaluating inotuzumab ozogamicin for Acute Lymphoblastic Leukemia. Completed, enrolled 44 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedJan 2023
Enrollment StartFeb 2023
Primary CompletionAug 2024
Study CompletionNov 2025
TodayJul 2026
First PostedJan 17, 2023
Enrollment StartFeb 24, 2023
Primary CompletionAug 7, 2024
Study CompletionNov 6, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.5 years ago
Interventions
inotuzumab ozogamicindrug
Given IV