Status:
COMPLETED
Primary Thrombocythaemia 1 Trial
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Conditions:
Thrombocythemia
Myeloproliferative Disorder
Eligibility:
All Genders
40-59 years
Phase:
NA
Brief Summary
The purpose of this trial is to see if Hydroxyurea + aspirin is a better treatment than aspirin alone for Intermediate Risk Primary Thrombocythemia (PT) patients.
Detailed Description
The myeloproliferative disease, primary thrombocythaemia (PT), has a median age of presentation of 60 years but is increasingly being recognised at an earlier age. The risks of the untreated condition...
Eligibility Criteria
Inclusion
- 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 criterion (see below). 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.
- The diagnostic criteria for primary thrombocythaemia are:
- Platelet count \> 600x109/l.
- No evidence of overt polycythaemia(confirmed by RCM if necessary)or of polycythaemia masked by co-existent iron deficiency.
- No Philadelphia chromosome.
- Absence of peripheral blood and/or marrow appearances of myelodysplasia, or myelofibrosis.
- No known cause of reactive thrombocytosis. Particular care should be taken to exclude iron deficiency in pre-menopausal women.
- Notes:
- In asymptomatic patients, the platelet count should be observed for a period of at least 2 months to confirm \>600x109/l, and to allow any cause of reactive thrombocytosis to become overt.
- If the PCV is above normal upper limit (that is, males \>0.51, females \>0.48) or in high normal range in a patient with palpable splenomegaly measure RCM. Iron deficient primary polycythaemia (polycythaemia vera) is strongly suggested if Hb/PCV is normal in the presence of iron deficient red cell changes. In this situation, iron therapy is potentially dangerous.
- Exceeding rarely, bcr-abl positive Philadelphia chromosome negative patients present with high platelet counts with little or no elevation in WBC count. The features that suggest it is necessary to examine for bcr-abl, are:- basophilia, left-shift in WBC, granulocyte count \>16x109/l, difficulty in controlling platelet count, megakaryocytes of low ploidy (NAP is usually unhelpful).
- A normal ESR, CRP or plasma viscosity is useful in excluding a reactive thrombocytosis.
- Written informed consent obtained in accordance with NCRI requirements.
- 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.
Exclusion
- High risk features (any of the following):
- Age \>or= 60 years
- Platelet count \> or= 1500x109/l (current or previous) (a)
- History of ischaemia, thrombosis or embolic events (including erythromelalgia) (b)
- Haemorrhage considered to be related to PT (b)
- Presence of hypertension (c)or diabetes (d)
- The manufacturers of hydroxyurea state that it should be avoided in pregnancy and in lactating women. Similarly, hydroxyurea should not be prescribed for women when there is doubt about their use of an effective contraceptive method.
- Exclude patient from hydroxyurea therapy and, therefore, from the 'intermediate' risk randomisation if the patient has current leg ulcers.
- Notes on the definition of high risk:
- In patients with borderline counts the allocation of a patient to a high risk group based on platelet count alone should rely on at least three samples taken on separate occasions over at least 2 months.
- Documentation of previous thrombo-embolic, ischaemic and haemorrhagic events should be given on the patient's entry proforma.
- Hypertension is defined as those patients requiring hypotensive therapy.
- Diabetes is defined as those patients requiring therapy with a hypoglycaemic agent.
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
1398 Patients enrolled
Trial Details
Trial ID
NCT00175838
Start Date
July 1 1997
End Date
November 1 2016
Last Update
January 18 2017
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, Cambs, United Kingdom, CB2 2QQ