Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy

Follicular Lymphoma Clinical Trial

— MERIT-NHL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01151358
• Other study ID #: MERIT-NHL
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2010
• Last updated: June 25, 2010
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: University Hospital, Saarland
• Contact: Aleksandar Grgic, MD
• Phone: +49-6841-16-22201
• Email: merit[@]uks.eu
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
Germany	Dept. of Nuclear Medicine, Saarland University Hospital	Homburg (Saar)	Saarland
Germany	Klinikum Karlsruhe, Dept. of Nuclear Medicine	Karlsruhe
Germany	University Clinic Kiel-Luebeck	Luebeck
Germany	Technical University, Dept. of Nuclear Medicine	Munich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy		3 years	No
Secondary	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		3 years	No