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

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