A randomized phase III study in previously untreated patients with biological high-risk CLL:

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 Putten
Datamanagement :
Edwin van Stein
Registration :

Erasmus MC – Daniel den Hoed

P.O.Box 5201

3008 AE ROTTERDAM

The Netherlands

tel. +31.10.4391568

fax +31.10.4391028
HOVON Data Center
https://www.hdc.hovon.nl/top

EudraCT number :
2005-000309-75
First version :
1 February 2004
This version :
April 14, 2008 (adjusted July 4, 2008)
Date of activation :
5 December 2005
Amendment 1 :

Amendment 2 : 14 April 2008
20 October 2005
Approved

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