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

Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346684
• Other study ID #: RIPL
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2006
• Last updated: August 11, 2008
• Start date: July 2006

Study information

• Verified date: August 2008
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany,