Back to resultsOfatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Primary Purpose
Relapsed NLPHL
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ofatumumab
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed NLPHL
Eligibility 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
Sites / Locations
- 1st Department of Medicine, Cologne University Hospital
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
duration of response
Progression free survival
adverse events
Full Information
NCT ID
NCT01187303
First Posted
August 19, 2010
Last Updated
October 30, 2015
Sponsor
University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT01187303
Brief Title
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Official Title
Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed NLPHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Intervention Description
300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
12 months after end of treatment
Secondary Outcome Measure Information:
Title
duration of response
Time Frame
12 months after end of treatment
Title
Progression free survival
Time Frame
12 months after end of treatment
Title
adverse events
Time Frame
12 months after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://ww.ghsg.org
Description
Homepage of the German Hodgkin Study Group
Learn more about this trial
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
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