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HD17 for Intermediate Stage Hodgkin Lymphoma

Information source: University of Cologne
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Lymphoma

Intervention: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) (Drug); ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine) (Drug); 30Gy IF-RT (Involved-Field Radiotherapy) (Radiation); 30Gy IN-RT (Involved-Node Radiotherapy) (Radiation)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Cologne

Official(s) and/or principal investigator(s):
Andreas Engert, Prof., Principal Investigator, Affiliation: University of Cologne, German Hodgkin Study Group

Overall contact:
Michael Fuchs, Email: ghsg@uk-koeln.de

Summary

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).

Clinical Details

Official title: HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival

Secondary outcome:

Overall Survival

CR rate

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hodgkin Lymphoma

- CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)

- large mediastinal mass (>1/3 of maximum transverse thorax diameter)

- extranodal involvement

- elevated ESR

- 3 or more involved nodal areas

- written informed consent

Exclusion Criteria:

- Leucocytes <3000/µl

- Platelets < 100000/µl

- Hodgkin Lymphoma as composite lymphoma

- Activity Index (WHO) >2

Locations and Contacts

Michael Fuchs, Email: ghsg@uk-koeln.de

1st Dept. of Medicine, Cologne University Hospital, Cologne, Germany; Recruiting
Andreas Engert, Prof., Email: a.engert@uni-koeln.de
Andreas Engert, Prof., Principal Investigator
Additional Information

Homepage GHSG

Starting date: December 2011
Last updated: December 16, 2014

Page last updated: August 23, 2015

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