Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®

Essential Thrombocythemia (ET) Clinical Trial

— EMIX  

Official title:

An Exploratory, Observational, Multicentre Study to Investigate the Impact of the Presence of JAK2 (V617F) Mutation on Treatment Response in Patients With Essential Thrombocythaemia Treated With XAGRID® (Anagrelide Hydrochloride)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352585
• Other study ID #: SPD422-703
• Status: Completed
• Start date: July 19, 2011
• Est. completion date: September 19, 2013

Study information

• Verified date: July 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 19, 2013
• Est. primary completion date: September 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients must be able to understand and willing to participate in the study, and provide a personally dated and signed written informed consent form.

2. Patients must have a confirmed diagnosis of ET according to the World health Organisation's criteria.

3. ET patients who are uncontrolled, in the Investigator's opinion, by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.

4. Patients who have either commenced treatment with anagrelide hydrochloride in the last 7 days or for whom a decision has been documented to commence treatment with anagrelide hydrochloride

Exclusion Criteria:

1. Patients for whom treatment with anagrelide hydrochloride is contraindicated, according to the current XAGRID SmPC.

2. Known or suspected intolerance or hypersensitivity to the product, closely related compounds, or any of the stated ingredients.

3. Patients participating in an interventional research study.

4. Patients on combination therapy or for whom there is an intention to treat with other cytoreductive agents e.g., hydroxyurea, interferon. Patients can however use aspirin and other anti-aggregatory products at the Investigator's discretion.

Related Conditions & MeSH terms

• Essential Thrombocythemia (ET)
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• Anagrelide hydrochloride
0.5 mg hard capsules, dosing decisions will be made by the treating physician

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Policlinico di Bari	Bari
Italy	Istituto Seragnoli-Policlinico S.Orsola-Malpighi	Bologna
Italy	A.O. Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Ospedale San Martino	Genova
Italy	Fondazione IRCCS Ca' Granda	Milan
Italy	Azienda Ospedaliera Universitaria "Federico II"	Napoli
Italy	Ospedale Maggiore della Carita	Novara
Italy	Policlinico A. Gemelli	Roma
Italy	Padiglione ex-oncologico Ospedale S.Maria	Terni

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cascavilla N, De Stefano V, Pane F, Pancrazzi A, Iurlo A, Gobbi M, Palandri F, Specchia G, Liberati AM, D'Adda M, Gaidano G, Fjerza R, Achenbach H, Smith J, Wilde P, Vannucchi AM. Impact of JAK2(V617F) mutation status on treatment response to anagrelide i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Platelet Count =600x10^9/L After 12 Months	A platelet count of =600x10^9/L after 12 months is considered at least a partial response.	1 year
Secondary	Number of Patients With Platelet Count =400x10^9/L After 12 Months	A platelet count of =400x10^9/L after 12 months is considered a complete response.	1 year
Secondary	Platelet Count		1 year
Secondary	Red Blood Cell (RBC) Count		1 year
Secondary	White Blood Cell (WBC) Count		1 year
Secondary	Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.		1 year
Secondary	Differential WBC Count - Eosinophils		1 year
Secondary	Hemoglobin Concentration		1 year
Secondary	Hematocrit Level	The proportion of the volume of red blood cells to the total volume of blood.	1 year