Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
NCT01187303
First received: August 19, 2010
Last updated: June 13, 2014
Last verified: June 2014
  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:


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 Study Completion Date: March 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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: June 13, 2014
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 September 16, 2014