Clinical trial NCT05954910: 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
Official title: The Effectiveness and Safety of Polatuzumab in Real-World Clinical Practice Among Chinese Adult Patients With Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Registry Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: At 24 months
measure: Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to end of study (EOS) (approximately 38 months)
Secondary outcomes:
measure: Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: At 24 months
measure: Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)
timeFrame: From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months)
measure: Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to EOS (approximately 38 months)
measure: Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to EOS (approximately 38 months)
measure: Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: Baseline up to EOS (approximately 38 months)
measure: Cohorts 1, 2 and 3: Duration of Response (DoR)
timeFrame: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 38 months)
measure: Cohorts 1 and 2: Disease Free Survival (DFS)
timeFrame: From the date of the first occurrence of a documented CR, to the date of relapse or death from any cause, whichever occurs first (up to approximately 38 months)
measure: Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
timeFrame: From the start of polatuzumab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 38 months)
measure: Cohorts 1, 2 and 3: Overall Survival (OS)
timeFrame: From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months)
measure: Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: Up to EOS (approximately 38 months)
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
city: Chengdu City
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
city: Haikou
country: China
facility: Hainan Cancer Hospital
city: Hohhot City
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
city: Nanchang City
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital Of Qingdao University
city: Shanghai City
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Shenyang City
country: China
facility: China Medical University (CMU) First Affiliated Hospital
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan City
country: China
facility: Shanxi Province Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Urumqi City
country: China
facility: Xinjiang Medical University Cancer Hospital
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: