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Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01187303
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

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

Condition or disease Intervention/treatment Phase
Relapsed NLPHL Drug: Ofatumumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Study Start Date : May 2011
Primary Completion Date : November 2013
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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


Intervention Details:
    Drug: Ofatumumab
    300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8


Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 12 months after end of treatment ]

Secondary Outcome Measures :
  1. duration of response [ Time Frame: 12 months after end of treatment ]
  2. Progression free survival [ Time Frame: 12 months after end of treatment ]
  3. adverse events [ Time Frame: 12 months after end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187303


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

Additional 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
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ofatumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs