Clinical trial NCT01151358: Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follicular Lymphoma
Keywords: radioimmunotherapy
follicular non-Hodgkin´s lymphoma
FDG-PET
prognostic factors
multicenter study
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.


Eligibility 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

Primary outcomes:
measure: Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Homburg (Saar)
country: Germany
facility: Dept. of Nuclear Medicine, Saarland University Hospital
state: Saarland
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe, Dept. of Nuclear Medicine
city: Luebeck
country: Germany
facility: University Clinic Kiel-Luebeck
city: Munich
country: Germany
facility: Technical University, Dept. of Nuclear Medicine
Study officials:
affiliation: Universitaetsklinikum des Saarlandes
name: Carl-Martin Kirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: