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Clinical picture: CML (Chronical Myeloide Leukemia)
Trial: HOVON 51 CML
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
HO51 news
Study closed per 01 March 2014. Data will be collected until the moment the patient is informed.
1. Overview
Summary
A dose-ranging phase I/II study of STI571 in combination with Cytarabin in patients with first chronic phase Chronic Myeloid Leukemia
Status
closed
Study details
Type of study
Prospective Phase I/II study
Type of monitoring for this study
None
Target number of patients
165
Current number of patients
164
Date of activation
14-Aug-2001
Date closed
01-Mar-2014
Approved by
CKTO: CKTO 2001-03, 9 July 2001
MEC: METC EUR/AZR 203.392/2001/166, 2 August 2001
MEC: METC EUR/AZR 203.392/2001/166, amendment 10 approved on 22 December 2011
2. Patient eligibility criteria
Inclusion criteria
Newly diagnosed patients with CML in first chronic phase <= 6 months;
Presence of Philadelphia chromosome or BCR-ABL rearrangement;
Age 18-65 years inclusive;
WHO performance status <= 2;
Written informed consent.
Late randomization
written informed consent.
received Imatinib maintenance as HOVON 51 protocol treatment.
Having achieved a complete molecular response (> 4.5 log reduction by quantitative PCR), which persists for at least 2 years.
WHO <2
Exclusion criteria
Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N);
Renal dysfunction (creatinin >= 200 mumol/l or 2.3 mg/dl);
Severe cardiac dysfunction (NYHA classification II-IV, see appendix G) ;
Severe pulmonary or neurologic disease;
Pregnant or lactating females;
Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
Patients known to be HIV-positive;
Patients with active, uncontrolled infections;
Previous treatment other than Hydroxyurea <= 6 months;
Late randomization:
Unable to visit outpatient clinic at regular one-monthly intervals during the first 6 months after stopping Imatinib.
3. Registration (& randomization) of patients
Registration
Central (late) 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 CML
Eligibility criteria
The patient should be registered within 6 months of diagnosis and before the start of STI571 monotherapy pre-phase.
Registration of patients will not be possible when the allowed number of patients have been entered at the current Dose Level, until the combination treatment and DLT evaluation for all patients has been completed.
Patients need to be registered at the HOVON Data Center of the University Hospital Rotterdam - Daniel by phone call: +31.10.7041560 or fax +31.10.7041028 Monday through Friday, from 09:00 to 17:00.
Contrary to other HOVON trials it will not be possible to register patients via the Internet via TOP (Trial Online Process), due to the fact that after every 5 or 10 registered patients the accrual is temporarily stopped.
The current status of the trial (open or temporarily closed) as well as the current Dose Level will be shown at the TOP website (http://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.
4. Participating parties
Principal Investigator(s)
Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Prof. Dr. G.J. Ossenkoppele (VUMC)
Prof. Dr. G.E.G. Verhoef (UZ Gasthuisberg)
Statistician(s)
Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)
Other functions
Central Coordinator - Molecular Diagnostics - Dhr. Dr. J.H. Jansen (Radboudumc)
Central Coordinator - Molecular Diagnostics - Dhr. Dr. P. Valk (Erasmus MC - Medische Faculteit)
Principal investigator
J.J. Cornelissen (j.cornelissen@erasmusmc.nl)
Coordinating investigator(s)
G.J. Ossenkoppele (g.ossenkoppele@vumc.nll)
G.E.G. Verhoef (gregor.verhoef@uz.kuleuven.ac.be)
Statistician(s)
B. van der Holt (b.vanderholt@erasmusmc.nl)
Trial manager
A.C. Gussinklo (a.gussinklo@erasmusmc.nl)
Central data management
A.C. Gussinklo (a.gussinklo@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.
