Diffuse Large B-Cell LymphomaNCT01724294
An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 1 site in Romania.
Trial summary
This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP… 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
- 113 participants
- Where
- 1 siteRomania
- Study dates
- Dec 2012to Apr 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: Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP
Who may be able to join
- Adult patients, >18 years of age
- Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP
Who cannot join
- Prior chemotherapy treatment for diffuse large B-cell lymphoma
- Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP
This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year 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.
Treatment patterns in clinical practice: Number of treatment cycles received
Measured: approximately 4 years
Secondary outcomes (3)
Event-free survival
Measured: approximately 4 years
Response rates
Measured: approximately 4 years
Safety: Incidence of adverse events
Measured: approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 113 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
- NCT01724294
- Sponsor's protocol ID
- ML28497
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP
- ClinicalTrials.gov ID
- NCT01724294
- Acronym / sponsor ID
- ML28497
- Conditions
- Diffuse Large B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Nov 2012 (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 multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year 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
- Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP
Key inclusion criteria (2 listed)
- Adult patients, >18 years of age
- Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP
Key exclusion criteria (2 listed)
- Prior chemotherapy treatment for diffuse large B-cell lymphoma
- Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
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
Treatment patterns in clinical practice: Number of treatment cycles received
Time frame: approximately 4 years
3 secondary outcomes
Event-free survival
Time frame: approximately 4 years
Response rates
Time frame: approximately 4 years
Safety: Incidence of adverse events
Time frame: approximately 4 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
1 site 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 1 site in Romania.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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 was stopped early. Results are not available in the source record.
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?
Treatment patterns in clinical practice: Number of treatment cycles received (time frame: approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.