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

Completed

• Conditions: Essential Thrombocythemia (ET)
• Interventions: Drug: Anagrelide hydrochloride

• Registration Number: NCT01352585
• Lead Sponsor: Shire

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Study Start: 2011-07-19
• Primary Completion: 2013-09-19
• Study Completion: 2013-09-19
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2014-06-27
• Results First Posted: 2014-07-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JAK2 Negative Participants	Anagrelide hydrochloride	-
JAK2 Positive Participants	Anagrelide hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Platelet Count ≤600x10^9/L After 12 Months	1 year	A platelet count of ≤600x10\^9/L after 12 months is considered at least a partial response.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Concentration	1 year
Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.	1 year
Number of Patients With Platelet Count ≤400x10^9/L After 12 Months	1 year	A platelet count of ≤400x10\^9/L after 12 months is considered a complete response.
Platelet Count	1 year
Red Blood Cell (RBC) Count	1 year
White Blood Cell (WBC) Count	1 year
Differential WBC Count - Eosinophils	1 year
Hematocrit Level	1 year	The proportion of the volume of red blood cells to the total volume of blood.

Trial Locations

Locations (10)

Padiglione ex-oncologico Ospedale S.Maria; 🇮🇹 Terni, Italy

Ospedale San Martino; 🇮🇹 Genova, Italy

Azienda Ospedaliera Universitaria "Federico II"; 🇮🇹 Napoli, Italy

Ospedale Maggiore della Carita; 🇮🇹 Novara, Italy

Fondazione IRCCS Ca' Granda; 🇮🇹 Milan, 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

Policlinico A. Gemelli; 🇮🇹 Roma, Italy