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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01340443
First received: April 20, 2011
Last updated: August 1, 2016
Last verified: August 2016
  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 ] [ 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: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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 ClinicalTrials.gov identifier: NCT01340443

Locations
China
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
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01340443     History of Changes
Other Study ID Numbers: ML25435 
Study First Received: April 20, 2011
Last Updated: August 1, 2016
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2016