Clinical trial NCT01340443: An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Previously untreated diffuse large B-cell lymphoma or follicular lymphoma patients

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 4.5 years
Secondary outcomes:
measure: Overall Response Rate (complete response + partial response)
timeFrame: 4.5 years
measure: Progression-free survival, defined as time from first treatment to lymphoma progression or death
timeFrame: 4.5 years
measure: Overall Survival, defined as time from 1st treatment to death of any cause
timeFrame: 4.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: Fuzhou General Hospital, PLA Nanjing Military Area Command
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guiyang
country: China
facility: The affiliated Hospital of Guiyang Medical College
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College
city: Hefei
country: China
facility: Anhui Province Cancer Hospital
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical College
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Kunming
country: China
facility: The First Affilliated Hospital of Kunming Medical College
city: Lanzhou
country: China
facility: Lanzhou General Hospital, PLA Lanzhou Military Area Command
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
city: Wuhan
country: China
facility: Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhongshan
country: China
facility: Zhongshan General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Wu 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.