Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

This study has been completed.
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
First received: August 19, 2010
Last updated: October 30, 2015
Last verified: October 2015
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: Allocation: Non-Randomized
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 ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: September 2015
Primary Completion Date: November 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01187303

1st Department of Medicine, Cologne University Hospital
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Principal Investigator: Andreas Engert, MD University of Cologne
  More Information

Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01187303     History of Changes
Other Study ID Numbers: Uni-Koeln-1432 
Study First Received: August 19, 2010
Last Updated: October 30, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on April 27, 2016