An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL
1 other identifier
observational
314
1 country
24
Brief Summary
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2011
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2016
CompletedNovember 14, 2017
November 1, 2017
5.5 years
April 20, 2011
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
4.5 years
Secondary Outcomes (3)
Overall Response Rate (complete response + partial response)
4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death
4.5 years
Overall Survival, defined as time from 1st treatment to death of any cause
4.5 years
Study Arms (1)
Cohort
Eligibility Criteria
Previously untreated diffuse large B-cell lymphoma or follicular lymphoma patients
You may qualify if:
- Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma
- Treatment with MabThera/Rituxan as per locally approved China package insert
- Documented patient with medical records
You may not qualify if:
- Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071, China
the First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital of Centre-South University
Changsha, 410008, China
Changzhou First People's Hospital
Changzhou, 213003, China
Daqing Oilfield General Hospital
Daqing, 163001, China
The First People's Hospital of Foshan
Foshan, China
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, 110016, China
Fujian Provincial Hospital
Fuzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
The affiliated Hospital of Guiyang Medical College
Guiyang, China
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, 310009, China
Anhui Province Cancer Hospital
Hefei, 12345, China
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, China
Shandong Cancer Hospital
Jinan, 250117, China
The First Affilliated Hospital of Kunming Medical College
Kunming, 650032, China
Lanzhou General Hospital, PLA Lanzhou Military Area Command
Lanzhou, 730050, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, 050035, China
Shanxi Province Cancer Hospital
Taiyuan, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Zhongshan General Hospital
Zhongshan, 528403, China
Related Publications (2)
Wu JQ, Song YP, Su LP, Zhang MZ, Li W, Hu Y, Zhang XH, Gao YH, Niu ZX, Feng R, Wang W, Peng JW, Li XL, Ouyang XN, Wu CP, Zhang WJ, Zeng Y, Xiao Z, Liang YM, Zhuang YZ, Wang JS, Sun ZM, Bai H, Cui TJ, Feng JF. Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study. Chin Med J (Engl). 2018 Aug 5;131(15):1767-1775. doi: 10.4103/0366-6999.237401.
PMID: 30058572DERIVEDWu J, Song Y, Su L, Xu L, Chen T, Zhao Z, Zhang M, Li W, Hu Y, Zhang X, Gao Y, Niu Z, Feng R, Wang W, Peng J, Li X, Ouyang X, Wu C, Zhang W, Zeng Y, Xiao Z, Liang Y, Zhuang Y, Wang J, Sun Z, Bai H, Cui T, Feng J. Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study. BMC Cancer. 2016 Jul 26;16:537. doi: 10.1186/s12885-016-2523-7.
PMID: 27460571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 22, 2011
Study Start
January 19, 2011
Primary Completion
July 15, 2016
Study Completion
July 15, 2016
Last Updated
November 14, 2017
Record last verified: 2017-11