Primary Thrombocythaemia-1 Trial (PT1)
PT1 is the largest ever study involving patients with the myeloproliferative disorder essential or primary thrombocythaemia (ET or PT). Well over a thousand patients have been enrolled to date and the study is recruiting throughout the UK, Northern Ireland and sites in Australia, New Zealand and France. The original protocol included high, intermediate and low risk arms. The high risk arm was a randomisation between hydroxyurea (also known as hydroxycarbamide) plus aspirin versus anagrelide plus aspirin. It closed in 2004 and the results, demonstrating the superiority of hydroxyurea plus aspirin, were published. The remaining two arms: the intermediate risk randomising between hydroxyurea plus aspirin versus aspirin alone, and an observational study for low risk patients on aspirin alone, are open for recruitment. The protocol is provided below. We are also collecting data for pregnancy in ET, and a link to further information is also provided below.
As well as guiding therapy we have been able to use clinical and biological samples (blood and bone marrow) collected from the study to make important observations about the impact of JAK2 V617F and MPL mutations; prognostic factors in ET; and lastly the difficulty in applying the current WHO histological criteria to ascertain the correct diagnosis.
Trial Documents.
- PT1 Protocol Version 4.0, 10 November 2009 (PDF)
- MREC Approval letter (PDF)
- MHRA Approval letter (PDF)
- Information & Consent forms - please contact Cathy MacLean for MS Word versions (contact details below)
Information for new UK centres wishing to participate in the PT1 Trial.
For MS Word versions please contact Cathy MacLean:
Cathy MacLean
PT-1 Trial Co-ordinator
Cambridge Cancer Trials Centre
Oncology Clinical Trials (S4)
Box 279, Addenbrookes Hospital
Hills Road, Cambridge
CB2 0QQ
Tel: 01223 348 450
Fax: 01223 216 407
Email: cathy.maclean@addenbrookes.nhs.uk
Pregnancy Study
- For information regarding the PT1 Pregnancy Substudy please click here.
Trial Forms
- Registration/Randomisation Process
- Serious adverse event form (PDF)
- Follow-up visit form (PDF)
- Quality of life form (PDF)
- Bone marrow histology (PDF)
Newsletters
- October 2010 (forthcoming)
- November 2008 (PDF)
- September 2007 (PDF)
- May 2007 (PDF)
Publications
- For a list of publications please click here.
