Follicular LymphomaMERIT-NHLNCT01151358
Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy
An observational study of Follicular Lymphoma, run by University Hospital, Saarland at 4 sites in Germany.
Trial summary
MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 150 participants
- Where
- 4 sitesGermany
- Study dates
- May 2008to Dec 2011
- 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 who suffer from a relapsed and/or refractory follicular non-Hodgkin´s lymphoma (FL) or patients with partial remission after induction chemotherapy of FL
Who may be able to join
- standard radioimmunotherapy with 90-yttrium-labeled anti-CD20-antibodies in treatment of relapsed and/or refractory follicular NHL or partial remission after induction chemotherapy
- finding of at least one image-guided measurable lymphoma lesion
- existence of FDG-PET- and CT-image data of at most 8 weeks before treatment
- signed patient´s agreement for RIT registry and MERIT-NHL
Who cannot join
- other therapy modalities than standard radioimmunotherapy (e.g. consolidation)
- solely CNS-lymphoma or primary effusion lymphoma
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 3 recruiting
- Recruiting
Dept. of Nuclear Medicine, Saarland University Hospital
Homburg (Saar), Saarland, 66421
Aleksandar Grgic, MD, +49-6841-16-22201, merit@uks.eu
- Recruiting
Klinikum Karlsruhe, Dept. of Nuclear Medicine
Karlsruhe
Cornelia Puskas, MD
- Active, not recruiting
University Clinic Kiel-Luebeck
Lübeck, 23538
- Recruiting
Technical University, Dept. of Nuclear Medicine
Munich
Klemens Scheidhauer, MD
About this study
Official title: Multicenter Prospective Evaluation of Patient- and Lesion Specific Prognostic Factors for Standard RadioImmunoTherapy With 90-Yttrium-labeled Anti-CD20 in Follicular Non-Hodgkin´s Lymphoma
MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive.
Based on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.
- Conditions
- Follicular Lymphoma
- Keywords
- radioimmunotherapy, follicular non-Hodgkin´s lymphoma, FDG-PET, prognostic factors, multicenter study
- Medical subject headings
- Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy
Measured: 3 years
Secondary outcomes (1)
Detection of diagnostical relevance of FDG-PET- and CT-image data findings in staging and re-staging of follicular non-Hodgkin´s lymphoma as well as in documentation of patient´s outcome after standard radioimmunotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Investigators
- Carl-Martin Kirsch, MD, Principal investigator, Universitaetsklinikum des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151358
- Sponsor's protocol ID
- MERIT-NHL
- Acronym
- MERIT-NHL
- Status last verified
- Jun 2010
- First submitted
- 24 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Evaluation of Patient- and Lesion Specific Prognostic Factors for Standard RadioImmunoTherapy With 90-Yttrium-labeled Anti-CD20 in Follicular Non-Hodgkin´s Lymphoma
- ClinicalTrials.gov ID
- NCT01151358
- Acronym / sponsor ID
- MERIT-NHL / MERIT-NHL
- Conditions
- Follicular Lymphoma
- Keywords
- radioimmunotherapy, follicular non-Hodgkin´s lymphoma, FDG-PET, prognostic factors, multicenter study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 28 Jun 2010 (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.
MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive.
Based on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffer from a relapsed and/or refractory follicular non-Hodgkin´s lymphoma (FL) or patients with partial remission after induction chemotherapy of FL
Key inclusion criteria (4 listed)
- standard radioimmunotherapy with 90-yttrium-labeled anti-CD20-antibodies in treatment of relapsed and/or refractory follicular NHL or partial remission after induction chemotherapy
- finding of at least one image-guided measurable lymphoma lesion
- existence of FDG-PET- and CT-image data of at most 8 weeks before treatment
- signed patient´s agreement for RIT registry and MERIT-NHL
Key exclusion criteria (2 listed)
- other therapy modalities than standard radioimmunotherapy (e.g. consolidation)
- solely CNS-lymphoma or primary effusion 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
Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy
Time frame: 3 years
1 secondary outcome
Detection of diagnostical relevance of FDG-PET- and CT-image data findings in staging and re-staging of follicular non-Hodgkin´s lymphoma as well as in documentation of patient´s outcome after standard radioimmunotherapy
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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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.
Carl-Martin Kirsch, MD principal investigator
Universitaetsklinikum des Saarlandes
4 sites 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 University Hospital, Saarland at 4 sites 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 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandar Grgic, MD (+49-6841-16-22201, merit@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy (time frame: 3 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 28 Jun 2010.