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

This study has been completed.

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00346684

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 II

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Rituximab Tositumomab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

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

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

Study ID Numbers:	RIPL
Study First Received:	June 29, 2006
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00346684
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Lymphoma
LPHD
Rituximab

Study placed in the following topic categories:

Lymphatic Diseases
Antibodies
Hodgkin's disease
Immunoproliferative Disorders
Rituximab

Hodgkin lymphoma, adult
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009