Evaluating Polatuzumab for Adult Chinese Patients with Diffuse Large B-Cell Lymphoma
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
This study is testing how well Polatuzumab works and how safe it is for adult Chinese patients with Diffuse Large B-Cell Lymphoma who may not have responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | cyclophosphamide, doxorubicin, prednisone, polatuzumab |
| Locations | 29 sites (Beijing City and 28 other locations) |
| Trial ID | NCT05954910 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and safety of Polatuzumab Vedotin in real-world clinical practice among adult Chinese patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL). It focuses on measuring progression-free survival (PFS) in different cohorts, including those who are unfit or frail, as well as patients who are relapsed or refractory to previous treatments. The study is observational and does not involve any interventional clinical trials. Participants will be monitored to gather data on their outcomes while receiving Polatuzumab in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adult patients diagnosed with DLBCL, particularly those who are unfit or frail, as well as those who have relapsed or are refractory to previous treatments.
Not a fit: Patients currently participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Polatuzumab for treating DLBCL in a real-world setting, potentially improving patient outcomes.
How similar studies have performed: While this study is observational, similar studies evaluating Polatuzumab in different populations have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing City and 28 other locations
- Peking Union Medical College Hospital — Beijing City, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Beijing Hospital of Ministry of Health — Beijing, China (Recruiting)
- Beijing Tongren Hospital, Capital Medical University — Beijing, China (Recruiting)
- The First Bethune Hospital of Jilin University — Changchun, China (Active_not_recruiting)
- Xiangya Hospital of Centre-South University — Changsha, China (Recruiting)
- Third Xiangya Hospital of Central South University — Changsha, China (Recruiting)
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu City, China (Recruiting)
- Zhujiang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
- Guizhou Cancer Hospital — Guiyang, China (Recruiting)
- Hainan Cancer Hospital — Haikou, China (Recruiting)
- Affiliated Hospital of Inner Mongolia Medical University — Hohhot City, China (Recruiting)
- Jiangxi Cancer Hospital — Nanchang City, China (Recruiting)
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) — Nanjing City, China (Recruiting)
- Jiangsu Cancer Hospital — Nanjing City, China (Recruiting)
- The Affiliated Hospital Of Qingdao University — Qingdao, China (Recruiting)
- Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai City, China (Recruiting)
- Tongji Hospital of Tongji University — Shanghai, China (Recruiting)
- China Medical University (CMU) First Affiliated Hospital — Shenyang City, China (Recruiting)
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, China (Active_not_recruiting)
- Shanxi Province Cancer Hospital — Taiyuan City, China (Recruiting)
- Tianjin Medical University General Hospital — Tianjin, China (Recruiting)
- Tianjin Cancer Hospital — Tianjin, China (Recruiting)
- Xinjiang Medical University Cancer Hospital — Urumqi City, China (Recruiting)
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan City, China (Recruiting)
- Wuxi People's Hospital — Wuxi, China (Recruiting)
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University — Xi'an, China (Recruiting)
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, China (Recruiting)
Study contacts
- Study coordinator: ML44616 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.