Follicular LymphomaNCT02536664
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
An observational study of Follicular Lymphoma, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Rituximab
- How many people
- 505 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician
Who may be able to join
- Age over 18 years
- Previously untreated, relapsed or refractory CD 20-positive FL
- Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
- To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
- No ineligibility for rituximab
Who cannot join
- Not Applicable (NA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RIM - Rituximab in Maintenance
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
- Conditions
- Follicular Lymphoma
- Being tested
- Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called MabThera®
| Study group | Role | What they receive |
|---|---|---|
| First-line Stratum | Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. Receives: Drug: Rituximab | |
| Relapsed/Refractory Stratum | Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Alive and Free From Progressive Disease
Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Measured: 2 years
Secondary outcomes (6)
Median Progression Free Survival (PFS) Time
PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.
Measured: 2 years
Percentage of Participants Who Were Alive
Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.
Measured: 2 years
Median Overall Survival (OS) Time
Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.
Measured: 2 years
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Measured: 2 years
Percentage of Participants With Best Overall Response
The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Measured: 2 years
Percentage of Participants With Initiation of New Therapy
Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular 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
- 505 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
- NCT02536664
- Sponsor's protocol ID
- ML22283
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2015
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIM - Rituximab in Maintenance
- ClinicalTrials.gov ID
- NCT02536664
- Acronym / sponsor ID
- ML22283
- Conditions
- Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line Stratum | – | Drug: RituximabParticipants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. |
| Relapsed/Refractory Stratum | – | Drug: RituximabParticipants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician
Key inclusion criteria (5 listed)
- Age over 18 years
- Previously untreated, relapsed or refractory CD 20-positive FL
- Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
- To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
- No ineligibility for rituximab
Key exclusion criteria (1 listed)
- Not Applicable (NA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: MabThera® | Drug | First-line Stratum, Relapsed/Refractory Stratum |
Primary outcome
Percentage of Participants Who Were Alive and Free From Progressive Disease
Time frame: 2 years
Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
6 secondary outcomes
Median Progression Free Survival (PFS) Time
Time frame: 2 years
Percentage of Participants Who Were Alive
Time frame: 2 years
Median Overall Survival (OS) Time
Time frame: 2 years
Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
Time frame: 2 years
Percentage of Participants With Best Overall Response
Time frame: 2 years
Percentage of Participants With Initiation of New Therapy
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Follicular Lymphoma, run by Hoffmann-La Roche at 1 site in Germany.
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 5 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 18 Apr 2023. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Were Alive and Free From Progressive Disease (time frame: 2 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 18 Apr 2023.