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

History of Changes

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:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

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

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eichenauer DA, Fuchs M, Pluetschow A, Klimm B, Halbsguth T, Böll B, von Tresckow B, Nogová L, Borchmann P, Engert A. Phase 2 study of rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2011 Oct 20;118(16):4363-5. Epub 2011 Aug 9.

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

ClinicalTrials.gov processed this record on June 17, 2013

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