Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Phase 2

Completed

• Conditions: Relapsed NLPHL

• Registration Number: NCT01187303
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2011-05
• Primary Completion: 2013-11
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate	12 months after end of treatment

Secondary Outcome Measures

Name	Time	Method
adverse events	12 months after end of treatment
duration of response	12 months after end of treatment
Progression free survival	12 months after end of treatment

Trial Locations

Locations (1)

1st Department of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany