Clinical trial NCT00202644: A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Official title: A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombocythemia, Hemorrhagic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of essential thrombocythaemia - high risk profile
* 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:

* Diagnosis of any other myeloproliferative disorder
* Any known cause for a secondary thrombocytosis
* Anti-coagulant and anti-aggregant therapies
* Known or suspected heart disease
* Left Ventricular Ejection Fraction \< 55%

Primary outcomes:
measure: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time
timeFrame: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36
measure: Platelet Count at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Change From Baseline in Platelet Counts at Month 3 and 36
timeFrame: Baseline and Month 3 and 36
measure: Percentage of Participants With Complete Response
timeFrame: Baseline up to Month 36
measure: Percentage of Participants With Partial Response
timeFrame: Baseline up to Month 36
measure: Time to Complete Response
timeFrame: Baseline up to Month 36
measure: Time to Partial Response
timeFrame: Baseline up to Month 36
measure: Number of Participants With Thrombotic and Haemorrhagic Events
timeFrame: From the signing of informed consent until the last study-related visit (Month 36)
measure: Change From Baseline in White Blood Cell Count Over Time
timeFrame: Baseline and Month 6, 12, 18, 24, 30 and 36
measure: Change From Baseline in Red Blood Cell Count Over Time
timeFrame: Baseline and Month 6, 12, 18, 24, 30 and 36
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology
city: Varna
country: Bulgaria
facility: University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic
city: Angers
country: France
facility: CHU Angers Services des Maladies du Sang
state: Cedex 09
city: Paris
country: France
facility: Hopital Saint Louis - Centre d'Investigation Clinique
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Centre
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital
city: Gyula
country: Hungary
facility: Pandy Kalman Hospital of Bekes County
city: Kaposvar
country: Hungary
facility: Kaposi Mor Teaching Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Warsaw
country: Poland
facility: Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej
city: Warsaw
country: Poland
facility: Klinika Hematologii Instytut Hematologii i Transfuzjologi
city: Coimbra
country: Portugal
facility: Hospitals da Universidade de Coimbra
city: Belgrade
country: Serbia
facility: Institute for Haematology of Clinical Centre of Serbia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.