Trial Title:
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT ID:
NCT05687032
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Inotuzumab Ozogamicin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
inotuzumab ozogamicin
Description:
Given IV
Arm group label:
inotuzumab ozogamicin
Other name:
Besponsa
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100091
Country:
China
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Facility:
Name:
Guangzhou First People's Hospital
Address:
City:
Guangzhou
Zip:
510180
Country:
China
Facility:
Name:
NanFang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510700
Country:
China
Facility:
Name:
The First Hospital of Harbin
Address:
City:
Harbin
Zip:
150010
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Wuhan Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Zip:
210008
Country:
China
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Facility:
Name:
The first Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical College
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
301600
Country:
China
Start date:
February 24, 2023
Completion date:
November 7, 2025
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687032
https://pmiform.com/clinical-trial-info-request?StudyID=B1931034
