Main info

Identificatie:

HOVON 58 ET

Sponsor:

HOVON

Included patients:

7

Active sites:

9

(of 9)

Title:

Pegylated interferon alpha-2a or anagrelide in high risk essential thrombocythemia. Observational study of low and intermediate risk patients.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a (previously*) confirmed diagnosis of ET according to the criteria of the WHO in appendix A
• Age 18-80 inclusive
• Written informed consent

• In case of previously diagnosed ET collagen fibrosis must be absent and reticulin fibrosis only minimal or absent in the bone marrow at entry

Registered patients are eligible for randomization if:

• they fulfill the inclusion and exclusion criteria for registration
• risk stratification is high risk
• written informed consent for randomization is obtained

Risk stratification
Management of patients with ET will be risk based, according to risk stratification groups as defined below.

Low risk - all of the following:
a. Age < 60 years
b. No history of or current bleeding, arterial, venous or microvascular thrombosis
c. Platelet count < 1500x109/l
d. No cardiovascular risk factors

High risk - any of the following:
a. Age >= 60 years
b. A history of or current bleeding, arterial or venous thrombosis
c. Platelet count >= 1500x109/l

Intermediate risk:
a. Neither low nor high risk

Cardiovascular risk factors are defined as:

• Hypercholesterolaemia (total cholesterol > 6 mmol/l);
• Hypertension (systolic > 140 mmHg, diastolic > 90 mmHg);
• Diabetes mellitus (according to the WHO criteria);

Family history of cardiovascular disease (>1 first degree family member with premature (<50 years) vascular disease);

• Smoking (current smoking > 5 cigarettes per day);
• Obesitas (BMI > 30).

Exclusion Criteria:

• Patients with renal dysfunction (creatinin > 1.5 times ULN)
• Patients with hepatic dysfunction (ALAT or ASAT > 2 times ULN or bilirubin > 1.5 times ULN)
• Patients previously treated with interferon alpha, pegylated interferon alpha-2a or anagrelide
• Patients with severe or refractory congestive cardiac failure defined as requiring multiple drug therapy
• Patients with a clinical history of class III or IV cardiac disease; defined as breathlessness or pain of cardiac origin on minimal exertion or at rest
• Patients with current severe arrhythmia e.g. ventricular tachycardia; atrial fibrillation is not an exclusion criterium
• Patients with thyroid dysfunction not responsive to therapy
• Patients who are known to be HIV-positive
• Patients with active and/or uncontrolled infection, including active hepatitis
• Patients with active malignancies
• Patients with a history of neuropsychiatric disorder requiring hospitalization
• Patients who have received any experimental therapy within 30 days prior to enrolment in this study
• Female patients who are pregnant, nursing or of reproductive potential and who are not practising effective means of contraception

Participating Sites

= Active hospitals

= Inactive hospitals