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 currently recruiting participants.
Verified August 2012 by Hoffmann-La Roche

First Received on April 20, 2011.  
Last Updated on August 15, 2012  
History of Changes
This Clinical Trial Sponsored By: Hoffmann-La Roche
Information provided by (Responsible Party): Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01340443
 

Purpose for Clinical Trial

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
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:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures For Clinical Trial:

  • Safety: Incidence of adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts

Cohort

  Eligibility

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340443

Contacts
Contact: Please reference Study ID Number: ML25435 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
China
Recruiting
Beijing, China, 100071
Recruiting
Chang Sha, China, 410008
Recruiting
Changchun, China, 130021
Recruiting
Changzhou City, China, 213003
Recruiting
Daqing City, China, 163001
Recruiting
Foshan, China
Recruiting
Fuzhou, China
Recruiting
Fuzhou, China, 350025
Recruiting
Guangzhou, China, 510515
Recruiting
Guiyang, China, 550004
Recruiting
Hangzhou, China, 310006
Recruiting
Hefei, China
Recruiting
Huhehaote, China
Recruiting
Jinan, China, 250117
Recruiting
Kunming, China, 650032
Recruiting
Lanzhou, China, 730050
Recruiting
Nanjing, China, 210009
Recruiting
Shijiazhuang, China, 50011
Recruiting
Taiyuan, China
Recruiting
Wuhan, China, 430022
Recruiting
Xi’an, China, 710038
Recruiting
Zhengzhou, China, 450052

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