CompletedInterventionalNot ApplicableUpdated Feb 4, 2015
HD18 for Advanced Stages in Hodgkins Lymphoma | NCT00515554 | Trialant
CompletedInterventionalPhase 3Updated Nov 13, 2020
HD18 for Advanced Stages in Hodgkins Lymphoma
ClinicalTrials.gov ID
NCT00515554
Lead Sponsor
University of CologneOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
1,500Actual
Last Update Posted
Nov 13, 2020Actual
Start Date
May 2008Actual
Primary Completion Date
Jul 2019Actual
Completion Date
Jul 2020Actual
Brief Summary
This study is designed to test:
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)
for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.
Hodgkins Lymphoma
Rituximab
BEACOPP escalated
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hodgkin 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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
1st Dept. of Medicine, Cologne University Hospital