Diffuse Large B-Cell Lymphoma Clinical Trial
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
| Verified date | November 2017 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 314 |
| Est. completion date | July 15, 2016 |
| Est. primary completion date | July 15, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | |
| China | the First Hospital of Jilin University | Changchun | |
| China | Xiangya Hospital of Centre-South University | Changsha | |
| China | Changzhou First People's Hospital | Changzhou | |
| China | Daqing Oilfield General Hospital | Daqing | |
| China | The First People's Hospital of Foshan | Foshan | |
| China | Fujian Provincial Hospital | Fuzhou | |
| China | Fuzhou General Hospital, PLA Nanjing Military Area Command | Fuzhou | |
| China | Nanfang Hospital, Southern Medical University | Guangzhou | |
| China | The affiliated Hospital of Guiyang Medical College | Guiyang | |
| China | The Second Affiliated Hospital of Zhejiang University College | Hangzhou | |
| China | Anhui Province Cancer Hospital | Hefei | |
| China | Affiliated Hospital of Inner Mongolia Medical College | Hohhot | |
| China | Shandong Cancer Hospital | Jinan | |
| China | The First Affilliated Hospital of Kunming Medical College | Kunming | |
| China | Lanzhou General Hospital, PLA Lanzhou Military Area Command | Lanzhou | |
| China | Jiangsu Cancer Hospital | Nanjing | |
| China | Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | |
| China | Shanxi Province Cancer Hospital | Taiyuan | |
| China | Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | Wuhan | |
| China | The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) | Xi'an | |
| China | Henan Cancer Hospital | Zhengzhou | |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | |
| China | Zhongshan General Hospital | Zhongshan |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Incidence of adverse events | 4.5 years | ||
| Secondary | Overall Response Rate (complete response + partial response) | 4.5 years | ||
| Secondary | Progression-free survival, defined as time from first treatment to lymphoma progression or death | 4.5 years | ||
| Secondary | Overall Survival, defined as time from 1st treatment to death of any cause | 4.5 years |
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