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

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00346684

RIPL

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)