Clinical trial NCT01065038: Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Thrombocythaemia
Lead sponsor: AOP Orphan Pharmaceuticals AG
Sponsor class: INDUSTRY
First posted: 2010-02-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points:

• ET is a rare disease and recruitment of large patient number (\> 1600) to prove superiority was not considered possible.

. It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.


Eligibility criteria: Inclusion Criteria:

* Presence of essential thrombocythaemia with high-risk profile.

Exclusion Criteria:

* previous treatment with cytoreductive drugs or Anagrelide
* pregnant women or women in childbearing age with inadequate contraception
* patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients
* known lactose intolerance
* cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio
* severe renal disease (Creatinin Clearance \< 30 ml/min)
* severe liver disease (AST or ALT \> 5-times normal)
* coexisting, malignant, systemic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Center Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Center AKH
city: Vienna
country: Austria
facility: Center Hanusch
city: Brno
country: Czech Republic
facility: Center Brno
city: Olomouc
country: Czech Republic
facility: Center Olomouc
city: Prague
country: Czech Republic
facility: Center Praha
city: Paris
country: France
facility: Center Paris
state: CLICHY Cedex
city: Munich
country: Germany
facility: Center Munich
state: Bavaria
city: Berlin
country: Germany
facility: Center Berlin
city: Halle
country: Germany
facility: Center Halle
city: Saarbrücken
country: Germany
facility: Center Saarbrücken
city: Ulm
country: Germany
facility: Center Ulm
city: Budapest
country: Hungary
facility: Center Budapest
city: Modena
country: Italy
facility: Center Modena
city: Pavia
country: Italy
facility: Center Pavia
city: Vilnius
country: Lithuania
facility: Center Vilnius
city: Gdansk
country: Poland
facility: Center Gdansk
city: Katowice
country: Poland
facility: Center Katowice
city: Krakow
country: Poland
facility: Center Krakow
city: Lodz
country: Poland
facility: Center Lodz
city: Lublin
country: Poland
facility: Center Lublin
city: Warszawa
country: Poland
facility: Center Warszawa
city: Singapore
country: Singapore
facility: Center Singapore
city: Ljubljana
country: Slovenia
facility: Center Ljubljana
Study officials:
References:
citation: Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.