Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy (MERIT-NHL)

June 25, 2010 updated by: University Hospital, Saarland

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aleksandar Grgic, MD
  • Phone Number: +49-6841-16-22201
  • Email: merit@uks.eu

Study Contact Backup

  • Name: Anja Hoock
  • Phone Number: +49-6841-16-22201
  • Email: merit@uks.eu

Study Locations

  • Germany
      • Karlsruhe, Germany
        • Recruiting
        • Klinikum Karlsruhe, Dept. of Nuclear Medicine
        • Contact:
          • Cornelia Puskas, MD
      • Luebeck, Germany, 23538
        • Active, not recruiting
        • University Clinic Kiel-Luebeck
      • Munich, Germany
        • Recruiting
        • Technical University, Dept. of Nuclear Medicine
        • Contact:
          • Klemens Scheidhauer, MD
    • Saarland
      • Homburg (Saar), Saarland, Germany, 66421
        • Recruiting
        • Dept. of Nuclear Medicine, Saarland University Hospital
        • Contact:
          • Aleksandar Grgic, MD
          • Phone Number: +49-6841-16-22201
          • Email: merit@uks.eu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of patient- and lesion specific prognostic factors of radioimmunotherapy
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome 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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Carl-Martin Kirsch, MD, Universitaetsklinikum des Saarlandes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2010

Last Update Submitted That Met QC Criteria

June 25, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MERIT-NHL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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