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

NCT ID: NCT01340443

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-19

Study Completion Date

2016-07-15

Brief Summary

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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

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Conditions

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Diffuse Large B-Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

Beijing, , China

Site Status

the First Hospital of Jilin University

Changchun, , China

Site Status

Xiangya Hospital of Centre-South University

Changsha, , China

Site Status

Changzhou First People's Hospital

Changzhou, , China

Site Status

Daqing Oilfield General Hospital

Daqing, , China

Site Status

The First People's Hospital of Foshan

Foshan, , China

Site Status

Fuzhou General Hospital, PLA Nanjing Military Area Command

Fuzhou, , China

Site Status

Fujian Provincial Hospital

Fuzhou, , China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

The affiliated Hospital of Guiyang Medical College

Guiyang, , China

Site Status

The Second Affiliated Hospital of Zhejiang University College

Hangzhou, , China

Site Status

Anhui Province Cancer Hospital

Hefei, , China

Site Status

Affiliated Hospital of Inner Mongolia Medical College

Hohhot, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

The First Affilliated Hospital of Kunming Medical College

Kunming, , China

Site Status

Lanzhou General Hospital, PLA Lanzhou Military Area Command

Lanzhou, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

Shijiazhuang, , China

Site Status

Shanxi Province Cancer Hospital

Taiyuan, , China

Site Status

Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

Wuhan, , China

Site Status

The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

Xi'an, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Zhongshan General Hospital

Zhongshan, , China

Site Status

Countries

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China

References

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Wu JQ, Song YP, Su LP, Zhang MZ, Li W, Hu Y, Zhang XH, Gao YH, Niu ZX, Feng R, Wang W, Peng JW, Li XL, Ouyang XN, Wu CP, Zhang WJ, Zeng Y, Xiao Z, Liang YM, Zhuang YZ, Wang JS, Sun ZM, Bai H, Cui TJ, Feng JF. Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study. Chin Med J (Engl). 2018 Aug 5;131(15):1767-1775. doi: 10.4103/0366-6999.237401.

Reference Type DERIVED
PMID: 30058572 (View on PubMed)

Wu J, Song Y, Su L, Xu L, Chen T, Zhao Z, Zhang M, Li W, Hu Y, Zhang X, Gao Y, Niu Z, Feng R, Wang W, Peng J, Li X, Ouyang X, Wu C, Zhang W, Zeng Y, Xiao Z, Liang Y, Zhuang Y, Wang J, Sun Z, Bai H, Cui T, Feng J. Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study. BMC Cancer. 2016 Jul 26;16:537. doi: 10.1186/s12885-016-2523-7.

Reference Type DERIVED
PMID: 27460571 (View on PubMed)

Other Identifiers

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ML25435

Identifier Type: -

Identifier Source: org_study_id