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Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

This study is currently recruiting participants.
Verified January 2013 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01187303
First received: August 19, 2010
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

Drug Information available for: Ofatumumab
U.S. FDA Resources

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
  Eligibility

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

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

Contacts
Contact: Michael Fuchs GHSG@uk-koeln.de

Locations
Germany
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
Investigators
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
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013