Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01151358

Acronym

MERIT-NHL

Enrollment

150

Registered

2010-06-28

Start date

2008-05-31

Completion date

2011-12-31

Last updated

2010-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Keywords

radioimmunotherapy, follicular non-Hodgkin´s lymphoma, FDG-PET, prognostic factors, multicenter study

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy	3 years

Secondary

Measure	Time frame
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

Countries

Germany

Contacts

Primary ContactAleksandar Grgic, MD

merit@uks.eu+49-6841-16-22201

Backup ContactAnja Hoock