NCT00346684

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

June 29, 2006

Last Update Submit

August 11, 2008

Conditions

Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Keywords

LymphomaLPHDRituximab

Interventions

RituximabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, 50931, Germany

Location

Related Publications (2)

  • 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.

    PMID: 31636342DERIVED

  • 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.

    PMID: 21828141DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andreas Engert

    Universitiy of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

June 30, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2007

Last Updated

August 12, 2008

Record last verified: 2008-08

Locations

DE(1)