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Trial Title:
Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy
NCT ID:
NCT01151358
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
radioimmunotherapy
follicular non-Hodgkin´s lymphoma
FDG-PET
prognostic factors
multicenter study
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- other therapy modalities than standard radioimmunotherapy (e.g. consolidation)
- solely CNS-lymphoma or primary effusion lymphoma
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept. of Nuclear Medicine, Saarland University Hospital
Address:
City:
Homburg (Saar)
Zip:
66421
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Aleksandar Grgic, MD
Phone:
+49-6841-16-22201
Email:
merit@uks.eu
Facility:
Name:
Klinikum Karlsruhe, Dept. of Nuclear Medicine
Address:
City:
Karlsruhe
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Cornelia Puskas, MD
Facility:
Name:
University Clinic Kiel-Luebeck
Address:
City:
Luebeck
Zip:
23538
Country:
Germany
Status:
Active, not recruiting
Facility:
Name:
Technical University, Dept. of Nuclear Medicine
Address:
City:
Munich
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Klemens Scheidhauer, MD
Start date:
May 2008
Completion date:
December 2011
Lead sponsor:
Agency:
University Hospital, Saarland
Agency class:
Other
Source:
University Hospital, Saarland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01151358
