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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON 68 CLL


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO68 news

As of 12NOV2010 the Ho68 CLL study is closed for inclusion of new patients.

Reason for closure is the publication of results of the CLL8 study. The Writing Committee no longer considers it feasible to randomise patients to FC chemotherapy without monoclonal antibody.

A letter of closure will be sent to all participating sites.


1. Overview



Summary

A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab


Status

open


Members

This study is activated in the Netherlands, Belgium, Denmark, Norway, Finland, Poland, Sweden, Czech Republic and Israel.



Type of study

Prospective randomized Phase III study


Type of monitoring for this study

Site evaluation visits


Target number of patients

300


Current number of patients

274


Date of activation

05-Dec-2005


Date closed

12-Nov-2010


Approved by

Belgium: 31 May 2007, 10 February 2010 (amendment 3)
Czech Republic: 06 September 2006
Denmark: 26 August 2005
Finland: 26 August 2005
Israel: 14 May 2008
The Netherlands METC: 24 November 2005 (amendment 1), 17 September 2008 (amendment 2), 19 April 2010 (amendment 3)
Norway: 23 June 2005
Poland: 13 February 2006
Sweden: 22 March 2006


Change history / amendement

Amendment 2 documents made available on October 03, 2008


Study objectives

Determination of the efficacy and safety of oral fludarabine and cyclophosphamide plus concomitant s.c. alemtuzumab compared to fludarabine and cyclophosphamide alone in terms of progression free survival, event free survival, clinical, flow cytometric and molecular response rates, overall survival and disease free survival.


2. Patient eligibility criteria



Inclusion criteria

Biological high-risk CLL*;
Patients with symptomatic** stage A, symptomatic** stage B or stage C (see appendix B);
Age 18-75 years inclusive;
Written informed consent. * Biological high risk is defined as: >= 98 % homology of IgVH genes with germ-line sequences and/or mutated CLL with usage of VH3-12 and/or FISH with 17p deletions and/or 11q deletions and/or trisomy 12.** Symptomatic CLL is defined according to the NCI criteria for active disease (Cheson et al. 1996, see appendix A).


Exclusion criteria

WHO performance status >= 3 (see appendix E), unless related to CLL;
Intolerance of exogenous protein administration;
Severe cardiac dysfunction (NYHA classification III-IV, see appendix F);
Significant renal dysfunction (serum creatinine >= 150 µmol/l or creatinine clearance < 30 ml/min);
Significant hepatic dysfunction (total bilirubin or transaminases > 2 times ULN), unless related to CLL;
Suspected or documented CNS involvement by CLL;
Known seropositivity of HIV, Hepatitis B and C
Active, uncontrolled infections;
Uncontrolled asthma or allergy requiring systemic steroid treatment;
Previously treated with chemotherapy, radiotherapy or immunotherapy for CLL;
History of active cancer during the past 5 years, except non-melanoma skin cancer or stage 0 cervical carcinoma;
Clinically significant auto-immune hemolytic anemia (AIHA);
Female patients who are pregnant or nursing;
Male and female patients of reproductive potential who are not practicing effective means of contraception,these include oral contraceptives, intrauterine device, depot injection of gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot plaster. These methods must be applied for the entire protocol treatment period, and for patients treated with alemtuzumab until at least 6 months after the end of alemtuzumab administration.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number
Sex
Date of birth
Date of diagnosis CLL
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Dr. C.H. Geisler (Rigshospitalet Copenhagen)


Co-Investigator(s)

Dr. A Deptala (Central Clinical Hospital Ministry of In)
Prof. Dr. M.H.J. van Oers (AMC)


Other functions

Central Coordinator - Molecular Diagnostics - Ms. A.M. Buhl (Rigshospitalet Copenhagen)
Central Coordinator - Molecular Diagnostics - Dr. J. Delabie (Radium Hospital)
Central Coordinator - Molecular Diagnostics - L.M. Evers (AMC)
Central Coordinator - Molecular Diagnostics - Dr. J. Jurlander (Rigshospitalet Copenhagen)
Central Coordinator - Molecular Diagnostics - V. Juvonen (Turku University Central Hospital)
Central Coordinator - Molecular Diagnostics - Dr. V. Kairisto (Turku University Central Hospital)
Central Coordinator - Molecular Diagnostics - A.W. Langerak (Erasmus MC - Centrum)
Central Coordinator - Molecular Diagnostics - Mw. Dr. K. van Lom (Erasmus MC - Centrum)
Central Coordinator - Molecular Diagnostics - B. Pienkowska (Central Clinical Hospital Ministry of In)
Central Coordinator - Molecular Diagnostics - R. Rosenquist (Uppsala University)
Central Coordinator - Molecular Diagnostics - J. Siedlecki (Maria Sklodowska-Curie Memorial)
Reviewer - Pathology - K. Beiske (Oslo Universitetssykehus)
Reviewer - Pathology - Dr. B. Christensson (Karolinska UH loc. Huddinge)
Reviewer - Pathology - Ms. Dr. N. Hastrup (Rigshospitalet Copenhagen)
Reviewer - Pathology - G. Rymkiewicz (Maria Sklodowska-Curie Memorial)
Reviewer - Pathology - K. Soderstrom (Turku University Central Hospital)
Reviewer - Pathology - Dhr. Dr. M.B. van 't Veer (Erasmus MC - Daniel)


Principal investigator

C. Geisler (christian.geisler@rh.hosp.dk)


Coordinating investigator(s)

R. van Oers (m.h.vanoers@amc.uva.nl)


Statistician(s)

W. Ghideyalemayehu (w.ghideyalemayehu@erasmusmc.nl)


Trial manager

M.C.J. Abrahamse - Testroote (m.testroote@erasmusmc.nl)


Central data management

M.C.J. Abrahamse - Testroote (m.testroote@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Middelheim
0
BE-Antwerpen-ZNA Stuivenberg
5
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Bruxelles-Cliniques Universitaires St. Luc
4
BE-Leuven-UZ Gasthuisberg
4
BE-Yvoir-Cliniques Universitaires de Mont-Godinne
1
CZ-Praag 10-University Hospital Kralovske Vinohrady
13
DK-Aalborg-Aalborg Hospital
5
DK-Aarhus C-Aarhus University Hospital
7
DK-Copenhagen-Rigshospitalet Copenhagen
25
Show 61 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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