Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)

NCT ID: NCT00346684

Last Updated: 2008-08-12

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

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab

Detailed Description

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Conditions

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Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Keywords

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Lymphoma LPHD Rituximab

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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Rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
* clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR \> 50mm/h)
* age 18 - 75
* WHO performance status 0-3
* normal organ function
* written informed consent

Exclusion Criteria

* classical Hodgkin´s lymphoma
* composite lymphoma
* leucocytes \< 3000/µl
* thrombocytes \< 100.000/µl
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

Principal Investigators

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Andreas Engert

Role: PRINCIPAL_INVESTIGATOR

Universitiy of Cologne

Locations

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University of Cologne

Cologne, , Germany

Site Status

Countries

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Germany

References

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Eichenauer DA, Plutschow A, Fuchs M, Hartmann S, Hansmann ML, Boll B, von Tresckow B, Borchmann P, Engert A. Rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: long-term follow-up of a phase 2 study from the German Hodgkin Study Group. Leukemia. 2020 Mar;34(3):953-956. doi: 10.1038/s41375-019-0609-3. Epub 2019 Oct 21. No abstract available.

Reference Type DERIVED
PMID: 31636342 (View on PubMed)

Eichenauer DA, Fuchs M, Pluetschow A, Klimm B, Halbsguth T, Boll B, von Tresckow B, Nogova L, Borchmann P, Engert A. Phase 2 study of rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2011 Oct 20;118(16):4363-5. doi: 10.1182/blood-2011-06-361055. Epub 2011 Aug 9.

Reference Type DERIVED
PMID: 21828141 (View on PubMed)

Other Identifiers

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RIPL

Identifier Type: -

Identifier Source: org_study_id