HD18 for Advanced Stages in Hodgkins Lymphoma
Information source: University of Cologne
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hodgkins Lymphoma
Intervention: Bleomycine (Drug); Etoposide (Drug); Doxorubicine (Drug); Cyclophosphamide (Drug); Vincristine (Drug); Procarbazine (Drug); Prednisone (Drug); Rituximab (Drug)
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
Overall contact:
Michael Fuchs, Email: GHSG@uk-koeln.de
Summary
This study is designed to test
1. in patients with negative positron-emission tomography (PET) after 2 cycles of
BEACOPPesc chemotherapy: whether the number of cycles can be reduced without
compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)
2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc
chemotherapy by adding Rituximab improves PFS.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Progression Free Survival
Secondary outcome: Overall Survival
acute and late toxicity
CR-rate
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hodgkin´s Lymphoma (histologically proven)
- CS (PS) IIB with one or both of the risk factors:
- bulky mediastinal mass (>1/3 of maximum transverse thorax diameter)
- extranodal involvement
- CS (PS) III, IV
- Written informed consent
Exclusion Criteria:
- Leucocytes <3000/µl
- Platelets <100000/µl
- Hodgkin´s lymphoma as "composite lymphoma"
- Activity index (WHO) < grade 2
Locations and Contacts
Michael Fuchs, Email: GHSG@uk-koeln.de
First Dept. of Medicine, Cologne University Hospital, Cologne 50924, Germany; Recruiting
Andreas Engert, MD, PhD, Email: a.engert@uni-koeln.de
Additional Information
Starting date: May 2008
Last updated: May 15, 2008
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