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

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ClinicalTrials.gov Identifier: NCT00346684
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : August 12, 2008
Sponsor:
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE June 29, 2006
First Posted Date  ICMJE June 30, 2006
Last Update Posted Date August 12, 2008
Study Start Date  ICMJE July 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00346684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)
Official Title  ICMJE 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.
Brief Summary First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)
Intervention  ICMJE Drug: Rituximab
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1182/blood-2011-06-361055. Epub 2011 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00346684
Other Study ID Numbers  ICMJE RIPL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Engert Universitiy of Cologne
PRS Account University of Cologne
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP