AOP 03-007 - ANAHYDRET Study
A single blind, multi-centre, randomised multinational Phase III Study to compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients with Essential Thrombocythaemia
   
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Appendix I:

a) Diagnostic Criteria: Essential Thrombocythaemia:
  • Platelet count > 600x109/L on two determinations separated by at least 1 month.
  • No cause for reactive thrombocytosis (inflam. syndrome, iron deficiency, haemolysis, asplenia, or neoplastic disease)
  • Normal serum ferritin and normal RBC MCV
  • Haematocrit < 45%, or normal RBC mass (< 125% of normal control values)
  • No Philadelphia chromosome or bcr/abl gene rearrangement.
  • No cytogenetic or morphologic evidence for a myelodysplastic syndrome (stainable iron in bone marrow but no evidence for ringed sideroblastic anemia).
  • Absence of marked splenomegaly and leukoerythoblastic reaction.
  • Increased number of large polyploid and clustering megakaryocytes without deviation in of nuclear-cytoplasmic maturation
  • No to minimal reticulin fibrosis

b) High risk profile at least one of the following:
  • Age ≥ 60 years;
  • Baseline platelet count ≥ 1.000x109/L
  • Increase in platelet count ≥ 300x109/L within 3 months
  • Presence of clinically significant vascular risk factors (symptomatic artheromatous plaques, carotid obstruction, aneurysm, bypass or amputation because of vasc.disease, cardiac valvular lesions, severe arterial hypertension with visceral manifestation i.e. cardiac, renal, retinal manif.)
  • History or current presence of severe ET-related thrombotic or thromboembolic episodes (myocard infarction, stroke, cerebrovasc. incident, arterial thrombosis, mesenteric infarction, pulm. embolism, portal thrombosis,deep vein thrombosis)
  • History or current presence of severe ET related ischemic episodes (TIA, angina pect., unstable angina, ocular symptoms, generalised convulsions, aspirin resistant erythromelalgia)
  • History of ET-related bleeding complications (severe mucocutaneous bleeding, gastrointest. bleed., cerebral bl., soft tissue bl.)



See also:
Study Protocol
Activity Sheet