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Completed

NCT Number: NCT01187303

Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

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

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Key information

Conditions

Relapsed NLPHL Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ofatumumab

Drug

300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8

Primary outcomes

  1. Overall response rate

    Time frame: 12 months after end of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 24, 2010
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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