Clinical trial NCT01192347: French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia
Official title: A Phase 4, Observational Study to Explore How Different Treatment Regimens Affect Continuation With Treatment in the First 6 Months Following Initiation of XAGRID Into Adult Patients' Essential Thrombocythemia Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Thrombocythemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See Eligibility Criteria

Brief summary: This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.


Eligibility criteria: Inclusion Criteria

1. Patients aged 18 years and older.
2. High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
3. Patients who have been on second- or third-line XAGRID treatment for up to 1 month, or for whom a decision has been documented to commence second line XAGRID treatment.
4. Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.

Exclusion Criteria

1. Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely related compounds, or any of the stated ingredients.
2. Patients for whom there is an intention to treat with combinations of cytoreductive therapy.
3. Patients participating in a separate clinical trial where their treatment is defined by that study protocol.

Primary outcomes:
measure: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy
timeFrame: 6 months
measure: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
measure: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
measure: Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy
timeFrame: 6 months
measure: Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
measure: Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Subjects With Anagrelide Hydrochloride Starting Doses
timeFrame: 6 months
measure: Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only
timeFrame: 6 months
measure: Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
timeFrame: 6 months
measure: Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy
timeFrame: 6 months
measure: Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
measure: Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
timeFrame: 6 months
measure: Maximum Daily Dose of Anagrelide Hydrochloride
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: GH Pitie Salpetriere
state: Cedex 13
city: Aix En Provence
country: France
facility: CH DU Pays D Aix
state: Cedex 1
city: Limoges
country: France
facility: Hopital Dupuytren
state: Cedex 1
city: Mulhouse
country: France
facility: Hopital Emile Muller
state: Cedex 1
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme
state: Cedex 1
city: Paris
country: France
facility: Hopital Tenon
state: Cedex 20
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
state: Cedex 2
city: Strasbourg
country: France
facility: Hopital Hautepierre
state: Cedex 2
city: Nice
country: France
facility: Hopital De L Archet
state: Cedex 3
city: Caen
country: France
facility: Clinique Du Parc
state: Cedex 4
city: Angers
country: France
facility: Hotel Dieu
state: Cedex 9
city: La Roche Sur Yon
country: France
facility: CH Departemental Des Oudairies
state: Cedex 9
city: Rennes
country: France
facility: Hopital Pontchaillou
state: Cedex 9
city: Toulon
country: France
facility: Hia Sainte Anne
state: Cedex 9
city: Arras
country: France
facility: Ch D Arras
state: Cedex
city: Aulnay Sous Bois
country: France
facility: Hopital Robert Ballanger
state: Cedex
city: Blois
country: France
facility: CH De Blois
state: Cedex
city: Bourg En Bresse
country: France
facility: Ch De Fleyriat
state: Cedex
city: Brest
country: France
facility: CME
state: Cedex
city: Brest
country: France
facility: Hopital Augustin Morvan
state: Cedex
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde
state: Cedex
city: Creteil
country: France
facility: Hopital Henri Mondor
state: Cedex
city: Le Kremlin Bicetre
country: France
facility: CH De Bicetre
state: Cedex
city: Lille
country: France
facility: CHRU Lille - Hopital Huriez
state: Cedex
city: Lomme
country: France
facility: Hopital Saint Philibert
state: Cedex
city: Lyon
country: France
facility: Hopital Edouard Herriot
state: Cedex
city: Marseille
country: France
facility: Institut J Paoli Calmettes
state: Cedex
city: Metz
country: France
facility: Hopital N D Bon Secours
state: Cedex
city: Montauban
country: France
facility: Clinique Pont de Chaume
state: Cedex
city: Paris
country: France
facility: Hopital Saint Antoine
state: Cedex
city: Paris
country: France
facility: GH Pitie Salpetriere
state: Cedex
city: Perpignan
country: France
facility: Hopital Saint Jean
state: Cedex
city: Pessac
country: France
facility: Hopital De Haut Leveque
state: Cedex
city: Poissy
country: France
facility: CHI Poissy Saint German en Laye
state: Cedex
city: Quimper
country: France
facility: Chi De Cornouaille
state: Cedex
city: Reims
country: France
facility: Hopital de La Maison Blanche
state: Cedex
city: Saint Priest En Jarez
country: France
facility: Institut de Cancerologie de la Loire
state: Cedex
city: Toulon
country: France
facility: Hopital Font Pre
state: Cedex
city: Vandoeuvre Les Nancy
country: France
facility: Hopitaux de Brabois
state: Cedex
city: Vendome
country: France
facility: Ch De Vendome
state: Cedex
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Marseille
country: France
facility: CHU Nord - Chemin Des Bourrely
city: Metz Tessy
country: France
facility: CHRA
city: Perpignan
country: France
facility: Cabinet D'Hematologie
city: Strasbourg
country: France
facility: Centre De Radiotherapie
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Rey J, Viallard JF, Keddad K, Smith J, Wilde P, Kiladjian JJ; FOX study investigators. Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in France. Eur J Haematol. 2014 Feb;92(2):127-36. doi: 10.1111/ejh.12210. Epub 2013 Nov 25.