Diffuse Large B-Cell LymphomaNCT01340443
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 24 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- How many people
- 314 participants
- Where
- 24 sitesChina
- Study dates
- 19 Jan 2011to 15 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Previously untreated diffuse large B-cell lymphoma or follicular lymphoma patients
Who may be able to join
- 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
Who cannot join
- Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071
the First Hospital of Jilin University
Changchun, 130021
Xiangya Hospital of Centre-South University
Changsha, 410008
Changzhou First People's Hospital
Changzhou, 213003
Daqing Oilfield General Hospital
Daqing, 163001
The First People's Hospital of Foshan
Foshan
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, 110016
Fujian Provincial Hospital
Fuzhou
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
The affiliated Hospital of Guiyang Medical College
Guiyang
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, 310009
Anhui Province Cancer Hospital
Hefei, 12345
Affiliated Hospital of Inner Mongolia Medical College
Hohhot
Shandong Cancer Hospital
Jinan, 250117
The First Affilliated Hospital of Kunming Medical College
Kunming, 650032
Lanzhou General Hospital, PLA Lanzhou Military Area Command
Lanzhou, 730050
Jiangsu Cancer Hospital
Nanjing, 210009
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, 050035
Shanxi Province Cancer Hospital
Taiyuan
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038
Henan Cancer Hospital
Zhengzhou, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Zhongshan General Hospital
Zhongshan, 528403
About this study
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
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.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: 4.5 years
Secondary outcomes (3)
Overall Response Rate (complete response + partial response)
Measured: 4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death
Measured: 4.5 years
Overall Survival, defined as time from 1st treatment to death of any cause
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study start19 Jan 2011
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340443
- Sponsor's protocol ID
- ML25435
- Status last verified
- Nov 2017
- First submitted
- 20 Apr 2011
- Last updated
- 14 Nov 2017
- Results posted
- No
Publications
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.
PubMed 30058572Wu 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.
PubMed 27460571
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01340443
- Acronym / sponsor ID
- ML25435
- Conditions
- Diffuse Large B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2011 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously untreated diffuse large B-cell lymphoma or follicular lymphoma patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety: Incidence of adverse events
Time frame: 4.5 years
3 secondary outcomes
Overall Response Rate (complete response + partial response)
Time frame: 4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death
Time frame: 4.5 years
Overall Survival, defined as time from 1st treatment to death of any cause
Time frame: 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 30058572Wu 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.
- Derived from this study: PubMed 27460571Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.