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

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00346684
First received: June 29, 2006
Last updated: August 11, 2008
Last verified: August 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00346684     History of Changes
Other Study ID Numbers: RIPL
Study First Received: June 29, 2006
Last Updated: August 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014