A randomised trial to compare ASPIRIN versus HYDROXYUREA/ASPIRIN in 'intermediate risk' primary thrombocythaemia and ASPIRIN only with observation in 'Low risk' primary thrombocythaemia. - PT1
- Conditions
- Intermediate risk and low risk primary thrombocythaemia.MedDRA version: 8.1Level: PTClassification code 10036735Term: Primary thrombocytopenia
- Registration Number
- EUCTR2004-000245-38-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1459
i) The proposal is to include as many patients with PT as possible including previously diagnosed patients whether or not they have received treatment. Thus all patients are eligible assuming they meet the diagnostic criteria and they do not have any exclusion criteria. It will be necessary to stratify patients according to their previous treatment. This information will be collected on entry to the study. Informed consent is of course required where there is a change of therapeutic strategy.
- Low risk : Age >or = 18 years and < 40 years with no high risk features (see exclusion criteria).
- Intermediate risk : Age 40-59 years with no high risk features (see exclusion criteria).
ii) The diagnostic criteria for primary thrombocythaemia are:
-1. Platelet count > 600 x 10 E+9 / L.
-2.. No evidence of overt polycythaemia (confirmed by RCM if necessary) or of polycythaemia masked by co-existent iron deficiency.
-3. No Philadelphia chromosome. .
-4.Absence of peripheral blood and/or marrow appearances of myelodysplasia, or myelofibrosis.
- No know cause of reactive thrombocytosis. Particular care should be taken to exclude iron deficiency in pre-menopausal women.
iii) Written informed consent obtained in accordance with NCRI requirements.
iv) Patients with impaired hepatic/renal function are not excluded although the respective biochemical tests should be monitored during therapy and reduced doses of cytoreductive agent should be used, particularly in the case of hydroxyurea and renal dysfunction.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
i) High risk features (any of the following) :
* Age > or = 60 years.
* Platelet count > or = 1500 x 10 E+9 / L (current or previous).
* History of ischaemia, thrombosis or embolic events (including erythromelalgia).
* Haemorrhage considered to be related to PT.
* Presence of hypertension or diabetes
ii) The manufacturers of hydroxyurea state that it should be avoided in pregnancy and in lactating women. Similary, hydroxyurea should not be prescribed for women when there is doubt about their use of an effective contraceptive method.
iii) Exclude patient from hydroxyurea therapy and, therefore, from the 'intermediate' risk randomisation if the patient has current leg ulcers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1) In low risk patients (aged > or = 18 years and < 40 years) : What is the incidence of thrombosis and major haemorrhage while receiving aspirin only?<br>2) In intermediate risk patients (aged 40-59 years) : Does hydroxyurea reduce thrombosis and major haemorrhage when added to aspirin?<br>3) What is the effect of the treatment modalities on quality of life?;Secondary Objective: In intermediate risk patients : Does treatment modality alter the risk of leukaemic or myelofibrotic transformation?;Primary end point(s): -The major primary end points are thrombotic and haemorrhagic events. <br>- Acute leukaemic transformation. <br>- Myelodysplastic transformation. <br>- Polycythaemic transformation.<br>- Myelofibrotic transformation
- Secondary Outcome Measures
Name Time Method