Trials / Completed
CompletedNCT05687032
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | inotuzumab ozogamicin | Given IV |
Timeline
- Start date
- 2023-02-24
- Primary completion
- 2024-08-07
- Completion
- 2025-11-06
- First posted
- 2023-01-17
- Last updated
- 2025-12-03
- Results posted
- 2025-08-07
Locations
16 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05687032. Inclusion in this directory is not an endorsement.