Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

This study is currently recruiting participants.
Verified January 2013 by University of Cologne
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
First received: August 19, 2010
Last updated: January 25, 2013
Last verified: January 2013

The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).

Condition Intervention Phase
Relapsed NLPHL
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of response [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ofatumumab
    300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • relapsed nodular lymphocyte predominant hodgkin lymphoma
  • age 18 - 75
  • review of diagnosis by experienced pathologist
  • no major organ dysfunction

Exclusion Criteria:

  • classical hodgkin lymphoma
  • CD20 antibody treatment within the last 6 months prior enrollment
  • chronic or current infectious disease requirering systemic antibiotics
  • other past or current malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187303

Contact: Michael Fuchs GHSG@uk-koeln.de

1st Department of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Michael Fuchs       GHSG@uk-koeln.de   
Principal Investigator: Andreas Engert, MD         
Sponsors and Collaborators
University of Cologne
Principal Investigator: Andreas Engert, MD University of Cologne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01187303     History of Changes
Other Study ID Numbers: Uni-Koeln-1432
Study First Received: August 19, 2010
Last Updated: January 25, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014