A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
NCT ID: NCT00202644
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2006-01-13
2015-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Anagrelide
Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
B
Hydroxyurea
Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
Interventions
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Anagrelide
Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.
Hydroxyurea
Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
Eligibility Criteria
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Inclusion Criteria
* Previously untreated with a cytoreductive agent
* Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study
Exclusion Criteria
* Any known cause for a secondary thrombocytosis
* Anti-coagulant and anti-aggregant therapies
* Known or suspected heart disease
* Left Ventricular Ejection Fraction \< 55%
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven
Pleven, , Bulgaria
University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic
Varna, , Bulgaria
CHU Angers Services des Maladies du Sang
Angers, Cedex 09, France
Hopital Saint Louis - Centre d'Investigation Clinique
Paris, , France
University of Debrecen Medical and Health Science Centre
Debrecen, , Hungary
Petz Aladar County Teaching Hospital
Győr, , Hungary
Pandy Kalman Hospital of Bekes County
Gyula, , Hungary
Kaposi Mor Teaching Hospital
Kaposvár, , Hungary
Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii
Gdansk, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, , Poland
Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej
Warsaw, , Poland
Klinika Hematologii Instytut Hematologii i Transfuzjologi
Warsaw, , Poland
Hospitals da Universidade de Coimbra
Coimbra, , Portugal
Institute for Haematology of Clinical Centre of Serbia
Belgrade, , Serbia
Countries
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References
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Birgegard G, Folkvaljon F, Garmo H, Holmberg L, Besses C, Griesshammer M, Gugliotta L, Wu J, Achenbach H, Kiladjian JJ, Harrison CN. Leukemic transformation and second cancers in 3649 patients with high-risk essential thrombocythemia in the EXELS study. Leuk Res. 2018 Nov;74:105-109. doi: 10.1016/j.leukres.2018.10.006. Epub 2018 Oct 11.
Gotic M, Egyed M, Gercheva L, Warzocha K, Kvasnicka HM, Achenbach H, Wu J. Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia. Cardiovasc Toxicol. 2021 Mar;21(3):236-247. doi: 10.1007/s12012-020-09615-0. Epub 2020 Oct 29.
Other Identifiers
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2004-004061-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD422-403
Identifier Type: -
Identifier Source: org_study_id
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