HOVON HO58

Archived

Main info

Identifier:
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

Scheduled
Actual
2004
12 May
Activated
2005
14 Nov
CloseoutInProgressLastPtOutActualStart
2015
14 Nov
Archived

Flow

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

Site
9 results
Order by
Accrual rate
Activation date
NL-Amsterdam-VUMC
5
NL-Rotterdam-ERASMUSMC
1
NL-Enschede-MST
1
NL-Amsterdam-AMC
NL-Den Haag-HAGA
NL-Amsterdam-OLVG
NL-Leidschendam-HMCANTONIUSHOVE
NL-Den Haag-HMCWESTEINDE
NL-Den Haag-HMCBRONOVO
= Active hospitals
= Inactive hospitals

Participating Parties

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