A randomized phase III study in previously untreated patients with biological high-risk CLL:
Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab
PROTOCOL
Study Coordinators :
Marinus van Oers (HOVON CLL Group)
Christian Geisler (Nordic Group)Statistician :
Wim van PuttenDatamanagement :
Edwin van SteinRegistration :
Erasmus MC – Daniel den Hoed
P.O.Box 5201
3008 AE ROTTERDAM
The Netherlands
tel.
fax +31.10.4391028
HOVON Data Centerhttps://www.hdc.hovon.nl/top
EudraCT number :
2005-000309-75First version :
1 February 2004This version :
April 14, 2008 (adjusted July 4, 2008)Date of activation :
5 December 2005Amendment 1 :
Amendment 2 : 14 April 2008
20 October 2005Approved
Czech Republic :
Denmark :
26 August 2005 (final version)Finland :
The Netherlands :
24 November 2005 (amendment 1)Norway :
23 June 2005 (final version)Poland :
Sweden :
Pełna wersja do pobrania w pliku PDF:
HO68_PRO_AM2_cleancopy.pdf