Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

NCT ID: NCT01187303

Last Updated: 2015-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Relapsed NLPHL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ofatumumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Engert

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Engert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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1st Department of Medicine, Cologne University Hospital

Cologne, , Germany

Site Status

Countries

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Germany

Related Links

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http://ww.ghsg.org

Homepage of the German Hodgkin Study Group

Other Identifiers

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Uni-Koeln-1432

Identifier Type: -

Identifier Source: org_study_id

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