A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT ID: NCT05687032
Last Updated: 2025-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2023-02-24
2025-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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inotuzumab ozogamicin
Dose: 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
inotuzumab ozogamicin
Given IV
Interventions
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inotuzumab ozogamicin
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Hospital of Harbin
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05687032
Identifier Type: REGISTRY
Identifier Source: secondary_id
B1931034
Identifier Type: -
Identifier Source: org_study_id
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