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Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346684
First Posted: June 30, 2006
Last Update Posted: August 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Cologne
  Purpose
First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab

Condition Intervention Phase
Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD) Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Study Start Date: July 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
  • clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR > 50mm/h)
  • age 18 - 75
  • WHO performance status 0-3
  • normal organ function
  • written informed consent

Exclusion Criteria:

  • classical Hodgkin´s lymphoma
  • composite lymphoma
  • leucocytes < 3000/µl
  • thrombocytes < 100.000/µl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346684


Locations
Germany
University of Cologne
Cologne, Germany, 50931
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert Universitiy of Cologne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00346684     History of Changes
Other Study ID Numbers: RIPL
First Submitted: June 29, 2006
First Posted: June 30, 2006
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by University of Cologne:
Lymphoma
LPHD
Rituximab

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents