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Clinical picture: CLL (Chronical Lymfatic Leukemia)
Trial: HOVON 68 CLL
News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
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.
Study details
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)
Central Coordinator - Molecular Diagnostics - Mw. Dr. K. van Lom (Erasmus MC)
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)
Other functions
Please contact monitors at hdcmonitorteam@erasmusmc.nl
5. Participating sites
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.
