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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 is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 20, 2011
Last updated: November 24, 2014
Last verified: November 2014

This observational study will evaluate the safety and efficacy of MabThera/Ritux an (rituximab) plus chemotherapy as first-line treatment in patients with diffus e large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collec ted from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.

Lymphoma, B-Cell

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate (complete response + partial response) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival, defined as time from first treatment to lymphoma progression or death [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Overall Survival, defined as time from 1st treatment to death of any cause [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Chang Sha, China, 410008
Changchun, China, 130021
Changzhou City, China, 213003
Daqing City, China, 163001
Foshan, China
Fuzhou, China, 350025
Fuzhou, China
Guangzhou, China, 510515
Guiyang, China
Hangzhou, China, 310009
Hefei, China
Hohhot, China
Jiangsu, China, 210009
Jinan, China, 250117
Kunming, China, 650032
Lanzhou, China, 730050
Shijiazhuang, China, 050011
Taiyuan, China
Wuhan, China, 430022
Xi'an, China, 710038
Zhengzhou, China, 450052
Zhengzhou, China, 450008
Zhongshan, China, 528403
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01340443     History of Changes
Other Study ID Numbers: ML25435
Study First Received: April 20, 2011
Last Updated: November 24, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on November 27, 2014