This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 20, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Diffuse Large B-Cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 4.5 years ]

Secondary Outcome Measures:
  • Overall Response Rate (complete response + partial response) [ Time Frame: 4.5 years ]
  • Progression-free survival, defined as time from first treatment to lymphoma progression or death [ Time Frame: 4.5 years ]
  • Overall Survival, defined as time from 1st treatment to death of any cause [ Time Frame: 4.5 years ]

Enrollment: 314
Study Start Date: January 2011
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Previously untreated diffuse large B-cell lymphoma or follicular lymphoma patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01340443

Beijing, China, 100071
Changchun, China, 130021
Changsha, China, 410008
Changzhou, China, 213003
Daqing, China, 163001
Foshan, China
Fuzhou, China, 110016
Fuzhou, China
Guangzhou, China, 510515
Guiyang, China
Hangzhou, China, 310009
Hefei, China, 12345
Hohhot, China
Jinan, China, 250117
Kunming, China, 650032
Lanzhou, China, 730050
Nanjing, China, 210009
Shijiazhuang, China, 050035
Taiyuan, China
Wuhan, China, 430022
Xi'an, China, 710038
Zhengzhou, China, 450008
Zhengzhou, China, 450052
Zhongshan, China, 528403
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01340443     History of Changes
Other Study ID Numbers: ML25435
Study First Received: April 20, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 19, 2017