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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340443
First Posted: April 22, 2011
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
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
Actual Study Start Date: January 19, 2011
Study Completion Date: July 15, 2016
Primary Completion Date: July 15, 2016 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340443


Locations
China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
the First Hospital of Jilin University
Changchun, China, 130021
Xiangya Hospital of Centre-South University
Changsha, China, 410008
Changzhou First People's Hospital
Changzhou, China, 213003
Daqing Oilfield General Hospital
Daqing, China, 163001
The First People's Hospital of Foshan
Foshan, China
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, China, 110016
Fujian Provincial Hospital
Fuzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China, 510515
The affiliated Hospital of Guiyang Medical College
Guiyang, China
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, China, 310009
Anhui Province Cancer Hospital
Hefei, China, 12345
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, China
Shandong Cancer Hospital
Jinan, China, 250117
The First Affilliated Hospital of Kunming Medical College
Kunming, China, 650032
Lanzhou General Hospital, PLA Lanzhou Military Area Command
Lanzhou, China, 730050
Jiangsu Cancer Hospital
Nanjing, China, 210009
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, China, 050035
Shanxi Province Cancer Hospital
Taiyuan, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430022
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, China, 710038
Henan Cancer Hospital
Zhengzhou, China, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450052
Zhongshan General Hospital
Zhongshan, China, 528403
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01340443     History of Changes
Other Study ID Numbers: ML25435
First Submitted: April 20, 2011
First Posted: April 22, 2011
Last Update Posted: November 14, 2017
Last Verified: November 2017

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