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Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma, Follicular
Conditions: Keywords
radioimmunotherapy, follicular non-Hodgkin´s lymphoma, FDG-PET, prognostic factors, multicenter study
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
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.
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Locations
Dept. of Nuclear Medicine, Saarland University Hospital
Homburg (Saar), Saarland, Germany
Klinikum Karlsruhe, Dept. of Nuclear Medicine
Status: Recruiting
Contact: Aleksandar Grgic, MD - +49-6841-16-22201 - merit@uks.eu
Karlsruhe, Germany
University Clinic Kiel-Luebeck
Status: Recruiting
Contact: Cornelia Puskas, MD
Luebeck, Germany
Technical University, Dept. of Nuclear Medicine
Status: Active, not recruiting
Munich, Germany
Status: Recruiting
Contact: Klemens Scheidhauer, MD
Start Date
May 2008
Completion Date
December 2011
Sponsors
University Hospital, Saarland
Source
University Hospital, Saarland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page