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)
2 other identifiers
interventional
44
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2023
Typical duration for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2024
CompletedResults Posted
Study results publicly available
August 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2025
CompletedDecember 3, 2025
November 1, 2025
1.5 years
January 6, 2023
July 22, 2025
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria
CR: disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) \>=1000 per microliter (/mcL) and platelets \>=100,000/mcL. C1 extramedullary disease (EMD) status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 centimeter (cm) in greatest transverse diameter (GTD) at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters (SPD). No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases were assessed using the same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<100,000/mcL.
From InO treatment initiation on Day 1 to CR or CRi (maximum up to 30.1 weeks of treatment exposure)
Secondary Outcomes (15)
Duration of Remission (DoR)
From date of first response in responders (CR/CRi) to the date of disease progression (objective progression, relapse from CR/CRi), death due to any cause, whichever occurred first (including post-study treatment follow-up disease assessment)
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Among Who Achieved CR/CRi
From CR/CRi till MRD negativity achieved (maximum up to 30.1 weeks of treatment exposure)
Progression-free Survival (PFS)
From date of first dose to the date of disease progression (objective progression, relapse from CR/CRi), or death due to any cause, whichever occurred first
Overall Survival (OS)
From date of first dose to the date of death due to any cause or censoring, whichever occurred first
Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)
From InO treatment initiation till study completion
- +10 more secondary outcomes
Study Arms (1)
inotuzumab ozogamicin
EXPERIMENTALDose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700, China
The First Hospital of Harbin
Harbin, Heilongjiang, 150010, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, 301600, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 17, 2023
Study Start
February 24, 2023
Primary Completion
August 7, 2024
Study Completion
November 6, 2025
Last Updated
December 3, 2025
Results First Posted
August 7, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.