Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy

NCT ID: NCT01151358

Last Updated: 2010-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Follicular Lymphoma

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Saarland

Principal Investigators

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Carl-Martin Kirsch, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum des Saarlandes

Locations

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Dept. of Nuclear Medicine, Saarland University Hospital

Homburg (Saar), Saarland, Germany

Site Status RECRUITING

Klinikum Karlsruhe, Dept. of Nuclear Medicine

Karlsruhe, , Germany

Site Status RECRUITING

University Clinic Kiel-Luebeck

Lübeck, , Germany

Site Status ACTIVE_NOT_RECRUITING

Technical University, Dept. of Nuclear Medicine

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Aleksandar Grgic, MD

Role: CONTACT

+49-6841-16-22201

Anja Hoock

Role: CONTACT

+49-6841-16-22201

Facility Contacts

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Aleksandar Grgic, MD

Role: primary

+49-6841-16-22201

Cornelia Puskas, MD

Role: primary

Klemens Scheidhauer, MD

Role: primary

Other Identifiers

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MERIT-NHL

Identifier Type: -

Identifier Source: org_study_id

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