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

Primary Purpose

Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Rituximab

About this trial

This is an interventional treatment trial for Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD) focused on measuring Lymphoma, LPHD, Rituximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Cologne

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00346684

First Posted

June 29, 2006

Last Updated

August 11, 2008

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT00346684

Brief Title

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

Official Title

Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Keywords

Lymphoma, LPHD, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rituximab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Engert

Organizational Affiliation

Universitiy of Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cologne

City

Cologne

ZIP/Postal Code

50931

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

31636342

Citation

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.

Results Reference

derived

PubMed Identifier

21828141

Citation

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.

Results Reference

derived

Learn more about this trial

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

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