Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
ANAHYDRET
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
1 other identifier
interventional
N/A
10 countries
24
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.
Trial Health
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24 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedOctober 6, 2010
September 1, 2005
February 8, 2010
October 5, 2010
Conditions
Study Arms (2)
Anagrelide
EXPERIMENTALHydroxyurea
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Presence of essential thrombocythaemia with high-risk profile.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Center Innsbruck
Innsbruck, Tyrol, 6020, Austria
Center AKH
Vienna, Vienna, 1090, Austria
Center Hanusch
Vienna, Vienna, 1140, Austria
Center Brno
Brno, 62500, Czechia
Center Olomouc
Olomouc, 77520, Czechia
Center Praha
Prague, 12808, Czechia
Center Paris
Paris, Clichy Cedex, 92118, France
Center Munich
Munich, Bavaria, 80331, Germany
Center Berlin
Berlin, 12200, Germany
Center Halle
Halle, 06111, Germany
Center Saarbrücken
Saarbrücken, 66113, Germany
Center Ulm
Ulm, 89081, Germany
Center Budapest
Budapest, 1097, Hungary
Center Modena
Modena, 41100, Italy
Center Pavia
Pavia, 27100, Italy
Center Vilnius
Vilnius, 2600, Lithuania
Center Gdansk
Gdansk, 80-211, Poland
Center Katowice
Katowice, 40-027, Poland
Center Krakow
Krakow, 31-501, Poland
Center Lodz
Lodz, 93-510, Poland
Center Lublin
Lublin, 20-079, Poland
Center Warszawa
Warsaw, 02-097, Poland
Center Singapore
Singapore, 169608, Singapore
Center Ljubljana
Ljubljana, Slovenia
Related Publications (1)
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.
PMID: 23315161DERIVED