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Clinical picture: CML (Chronical Myeloide Leukemia)

Trial: HOVON 51 CML


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


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



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



Site
Included patients *
BE-Brugge-Algemeen Ziekenhuis St. Jan
0
BE-Bruxelles-Cliniques Universitaires St. Luc
6
BE-Leuven-UZ Gasthuisberg
12
NL-Amersfoort-Meander MC
5
NL-Amsterdam-AMC
11
NL-Amsterdam-VUMC
26
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
2
NL-Deventer-Deventer ziekenhuizen
0
NL-Enschede-Medisch Spectrum Twente
14
NL-Groningen-UMCG
10
Show 6 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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