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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01340443
First received: April 20, 2011
Last updated: May 23, 2013
Last verified: May 2013
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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 |
|---|
|
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:
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: | April 2016 |
| Estimated Primary Completion Date: | April 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
Locations
| China | |
| Beijing, China, 100071 | |
| Chang Sha, China, 410008 | |
| Changchun, China, 130021 | |
| Changzhou City, China, 213003 | |
| Daqing City, China, 163001 | |
| Foshan, China | |
| Fuzhou, China | |
| Fuzhou, China, 350025 | |
| Guangzhou, China, 510515 | |
| Guiyang, China | |
| Hangzhou, China, 310009 | |
| Hefei, China | |
| Huhehaote, 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, 450052 | |
| Zhengzhou, China, 450008 | |
| Zhongshan, China | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| 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: | May 23, 2013 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular 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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013