Trial Title:
A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma
NCT ID:
NCT05954910
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Polatuzumab vedotin
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Polatuzumab Vedotin
Description:
Polatuzumab vedotin will be administered at the discretion of the physician per local
clinical practice and local labeling.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Other name:
POLIVY ®
Summary:
The purpose of this study is to assess the progression free survival (PFS) in the
real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL)
participants.
Criteria for eligibility:
Study pop:
Participants who will be treated with polatuzumab (known as being recommended and having
the intention to be treated with polatuzumab at the time of signing informed consent) or
have initiated polatuzumab treatment within three months prior to enrollment and after
the indication approval will be observed in this study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Be diagnosed as DLBCL
- Cohort 1: diagnosed as unfit/frail DLBCL. The unfit/frail is defined as aged 80
years or older, or younger than 80 years but with comorbidity and not tolerant to
the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone
(CHOP) therapy according to investigator's judgment
- Cohort 2: diagnosis as DLBCL but could not be classified into unfit/frail
- Cohort 3: relapse or refractory to previous treatment
Exclusion Criteria:
- Participant who currently participates in or with plan to participate in any
interventional clinical trial
- Any other reason that, in the investigator's opinion, makes the participant
unsuitable to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing City
Zip:
100032
Country:
China
Status:
Recruiting
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Hospital of Ministry of Health; Hematology
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tongren Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Active, not recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu City
Zip:
610041
Country:
China
Status:
Withdrawn
Facility:
Name:
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Address:
City:
Chengdu City
Zip:
610072
Country:
China
Status:
Recruiting
Facility:
Name:
Zhujiang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Facility:
Name:
Guizhou Cancer Hospital
Address:
City:
Guiyang
Zip:
550004
Country:
China
Status:
Recruiting
Facility:
Name:
Hainan Cancer Hospital
Address:
City:
Haikou
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot City
Zip:
010000
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang City
Zip:
330029
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Address:
City:
Nanjing City
Zip:
210029
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing City
Zip:
211100
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning City
Zip:
530021
Country:
China
Status:
Withdrawn
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine; hemotology
Address:
City:
Shanghai City
Zip:
200025
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital of Tongji University
Address:
City:
Shanghai
Zip:
200065
Country:
China
Status:
Recruiting
Facility:
Name:
China Medical University (CMU) First Affiliated Hospital
Address:
City:
Shenyang City
Zip:
110001
Country:
China
Status:
Recruiting
Facility:
Name:
The Fourth Hospital of Hebei Medical University; Hematology department
Address:
City:
Shijiazhuang
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Shanxi Province Cancer Hospital
Address:
City:
Taiyuan City
Zip:
030013
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
Xinjiang Medical University Cancer Hospital
Address:
City:
Urumqi City
Zip:
830011
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan City
Zip:
430023
Country:
China
Status:
Recruiting
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Zip:
214023
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital; Oncology
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Start date:
August 25, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954910
