| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| ISRCTN | ISRCTN72251782 |
| Serial number at source | MRC PT1 |
| Title of trial | A Medical Research Council Randomised Trial to Compare Aspirin versus Hydroxyurea/Aspirin in Intermediate Risk Primary Thrombocythaemia and Hydroxyurea/Aspirin versus Anagrelide/Aspirin in High Risk Primary Thrombocythaemia |
| Disease or condition | Leukaemia (chronic) |
| Current status of trial | Open |
| Objectives | 1. To assess the incidence of vascular occlusion in low risk patients while receiving aspirin only.
2. To determine whether hydroxyurea reduces vascular occlusive events when added to aspirin in intermediate risk patients.
3. To determine whether anagrelide reduces vascular occlusive events as effectively as hydroxyurea in high risk patients
4. To determine whether anagrelide is as effective as hydroxyurea in reducing elevated platelet counts in high risk patients.
5. To assess the effect of the treatment modalities on quality of life.
6. To assess whether in high and intermediate risk patients treatment modality alters the risk of leukaemia and myelofibrotic transformations. |
| Design/methodology | 1. Patients are stratified according to previous treatment 2. The endpoints of the trial are: - Vascular occlusive and haemorrhagic events - Acute leukaemia transformation - Myelodysplastic transformation - Polycythaemic transformation - Myelofibrotic transformation - Death |
| Eligibility criteria | 1. All patients with primary thrombocythaemia (PT)
2. Patients should meet the diagnostic criteria for PT:
- Platelet count >600x10(9)/l
- No evidence of overt polycythaemia
- No Philadelphia chromosome
- Absence of peripheral blood and/or bone marrow appearances of myelodysplasia or myelofibrosis
- No known cause of reactive thrombocytosis
3. Not pregnant or lactating
4. No current leg ulcers
5. Patients with known heart conditions may in certain cases be excluded |
| Sample size | Current accrual: 792 |
| Randomised interventions | LOW-RISK PATIENTS
All patients receive aspirin, 75mg daily
INTERMEDIATE-RISK PATIENTS
Patients are randomised to one of two treatment arms:
1. Arm A:
Aspirin, 75mg orally per day
2. Arm B:
Aspirin 75mg daily plus hydroxyurea 0.5g - 1.0g daily
HIGH-RISK PATIENTS
Patients are randomised to one of two treatment arms:
1. Arm C:
Aspirin 75mg daily plus hydroxyurea 0.5g - 1.0g daily
2. Arm D:
Aspirin 75mg daily plus anagrelide. Anagrelide is given at a starting dose of 0.5mg twice daily which can be increased by 0.5mg per day every one to two weeks to a maximum dose of 10mg per day (average 2-2.5mg daily). |
| Sponsor | Medical Research Council |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
|
| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
