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

Completed

• Conditions: Diffuse Large B-Cell Lymphoma

• Registration Number: NCT01340443
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-19
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-22
• Primary Completion: 2016-07-15
• Study Completion: 2016-07-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

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Exclusion Criteria

• Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	4.5 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival, defined as time from 1st treatment to death of any cause	4.5 years
Overall Response Rate (complete response + partial response)	4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death	4.5 years

Trial Locations

Locations (24)

Xiangya Hospital of Centre-South University; 🇨🇳 Changsha, China

Lanzhou General Hospital, PLA Lanzhou Military Area Command; 🇨🇳 Lanzhou, China

the First Hospital of Jilin University; 🇨🇳 Changchun, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, China

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA); 🇨🇳 Beijing, China

The Second Affiliated Hospital of Zhejiang University College; 🇨🇳 Hangzhou, China

The affiliated Hospital of Guiyang Medical College; 🇨🇳 Guiyang, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, China

Changzhou First People's Hospital; 🇨🇳 Changzhou, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China

Fuzhou General Hospital, PLA Nanjing Military Area Command; 🇨🇳 Fuzhou, China

Anhui Province Cancer Hospital; 🇨🇳 Hefei, China

Affiliated Hospital of Inner Mongolia Medical College; 🇨🇳 Hohhot, China

The First Affilliated Hospital of Kunming Medical College; 🇨🇳 Kunming, China

Shanxi Province Cancer Hospital; 🇨🇳 Taiyuan, China

Shandong Cancer Hospital; 🇨🇳 Jinan, China

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province); 🇨🇳 Shijiazhuang, China

Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology; 🇨🇳 Wuhan, China

The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital); 🇨🇳 Xi'an, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

Zhongshan General Hospital; 🇨🇳 Zhongshan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China