sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: Other (Other)

Trial: HOVON 58 ET


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


return to top

News


No news


1. Overview



Summary

Pegylated interferon alpha-2a or anagrelide in high risk essential thrombocythemia. Observational study of low and intermediate risk patients.


Status

closed



Type of study

Prospective Phase II study


Target number of patients

264


Current number of patients

7


Date of activation

12-May-2004


Date closed

14-Nov-2005


Approved by

CKTO: CKTO 2003-17, 10 May 2004
METC: VUMC 2004/008, 22 April 2004


2. Patient eligibility criteria



Inclusion criteria

Patients with a (previously*) confirmed diagnosis of ET according to the criteria of the WHO in appendix A
Age 18-80 inclusive
Written informed consent

* In case of previously diagnosed ET collagen fibrosis must be absent and reticulin fibrosis only minimal or absent in the bone marrow at entry

Registered patients are eligible for randomization if:
they fulfill the inclusion and exclusion criteria for registration
risk stratification is high risk
written informed consent for randomization is obtained

Risk stratification
Management of patients with ET will be risk based, according to risk stratification groups as defined below.

Low risk - all of the following:
a. Age < 60 years
b. No history of or current bleeding, arterial, venous or microvascular thrombosis
c. Platelet count < 1500x109/l
d. No cardiovascular risk factors

High risk - any of the following:
a. Age >= 60 years
b. A history of or current bleeding, arterial or venous thrombosis
c. Platelet count >= 1500x109/l

Intermediate risk:
a. Neither low nor high risk

Cardiovascular risk factors are defined as:
Hypercholesterolaemia (total cholesterol > 6 mmol/l);
Hypertension (systolic > 140 mmHg, diastolic > 90 mmHg);
Diabetes mellitus (according to the WHO criteria);
Family history of cardiovascular disease (>1 first degree family member with premature (<50 years) vascular disease);
Smoking (current smoking > 5 cigarettes per day);
Obesitas (BMI > 30).


Exclusion criteria

Patients with renal dysfunction (creatinin > 1.5 times ULN)
Patients with hepatic dysfunction (ALAT or ASAT > 2 times ULN or bilirubin > 1.5 times ULN)
Patients previously treated with interferon alpha, pegylated interferon alpha-2a or anagrelide
Patients with severe or refractory congestive cardiac failure defined as requiring multiple drug therapy
Patients with a clinical history of class III or IV cardiac disease; defined as breathlessness or pain of cardiac origin on minimal exertion or at rest
Patients with current severe arrhythmia e.g. ventricular tachycardia; atrial fibrillation is not an exclusion criterium
Patients with thyroid dysfunction not responsive to therapy
Patients who are known to be HIV-positive
Patients with active and/or uncontrolled infection, including active hepatitis
Patients with active malignancies
Patients with a history of neuropsychiatric disorder requiring hospitalization
Patients who have received any experimental therapy within 30 days prior to enrolment in this study
Female patients who are pregnant, nursing or of reproductive potential and who are not practising effective means of contraception


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 of ET
WHO performance status
Risk stratification
Eligibility criteria

The following information will be requested at randomization:
Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient study number
Date of diagnosis of high risk ET
Eligibility criteria
Date of start treatment


4. Participating parties



Principal Investigator(s)

Dhr. Dr. M.R. de Groot (UMCG)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)
Prof. Dr. S. Zweegman (VUMC)


Other functions

Reviewer - Pathology - Dhr. Dr. J.J. Oudejans (Diakonessenhuis)


Principal investigator

S. Zweegman (s.zweegman@vumc.nl)


Coordinating investigator(s)

M.R. de Groot (m.degroot@ziekenhuis-mst.nl)
P. Sonneveld (p.sonneveld@erasmusmc.nl)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

E.J. van Stein (e.vanstein@erasmusmc.nl)


Central data management

E.J. van Stein (e.vanstein@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
0
NL-Amsterdam-OLVG
0
NL-Amsterdam-VUMC
5
NL-Den Haag-Bronovo ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Den Haag-MC Haaglanden, Westeinde
0
NL-Enschede-Medisch Spectrum Twente
1
NL-Leidschendam-MC Haaglanden, Antoniushove
0
NL-Rotterdam-Erasmus MC - Centrum
1

* 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



return to top