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

Diffuse Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954910
• Other study ID #: ML44616
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: ML44616 https://forpatients.roche.com/
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Polatuzumab Vedotin
Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.

Locations

Country	Name	City	State
China	Beijing Hospital of Ministry of Health; Hematology	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing
China	Peking University Third Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing City
China	The First Bethune Hospital of Jilin University	Changchun
China	Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital	Chengdu City
China	Zhujiang Hospital, Southern Medical University	Guangzhou
China	Guizhou Cancer Hospital	Guiyang
China	Affiliated Hospital of Inner Mongolia Medical University	Hohhot City
China	Jiangxi Cancer Hospital	Nanchang City
China	Jiangsu Cancer Hospital	Nanjing City
China	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning City
China	Tongji Hospital of Tongji University	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine; hemotology	Shanghai City
China	China Medical University (CMU) First Affiliated Hospital	Shenyang City
China	The Fourth Hospital of Hebei Medical University; Hematology department	Shijiazhuang
China	Shanxi Province Cancer Hospital	Taiyuan City
China	Tianjin Cancer Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Xinjiang Medical University Cancer Hospital	Urumqi City
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Wuxi People's Hospital	Wuxi
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Henan Cancer Hospital; Oncology	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		At 24 months
Primary	Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		Baseline up to end of study (EOS) (approximately 38 months)
Secondary	Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		At 24 months
Secondary	Cohorts 1, 2 and 3: Time to Next Treatment (TTNT)		From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months)
Secondary	Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		Baseline up to EOS (approximately 38 months)
Secondary	Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		Baseline up to EOS (approximately 38 months)
Secondary	Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		Baseline up to EOS (approximately 38 months)
Secondary	Cohorts 1, 2 and 3: Duration of Response (DoR)		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)
Secondary	Cohorts 1 and 2: Disease Free Survival (DFS)		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)
Secondary	Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma		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)
Secondary	Cohorts 1, 2 and 3: Overall Survival (OS)		From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months)
Secondary	Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to EOS (approximately 38 months)