French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia (FOX)

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

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.

Study Overview

• Status: Completed
• Conditions: Essential Thrombocythemia

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33300
    • Polyclinique Bordeaux Nord Aquitaine
  • Libourne, France, 33505
    • Hôpital Robert Boulin
  • Marseille, France, 13015
    • CHU Nord - Chemin Des Bourrely
  • Metz Tessy, France, 74370
    • CHRA
  • Perpignan, France, 66000
    • Cabinet D'Hematologie
  • Strasbourg, France, 67000
    • Centre de Radiotherapie
  • Cedex
    • Arras, Cedex, France, 62022
      • Ch D Arras
    • Aulnay Sous Bois, Cedex, France, 93602
      • Hopital Robert Ballanger
    • Blois, Cedex, France, 41016
      • CH de Blois
    • Bourg En Bresse, Cedex, France, 1012
      • Ch de Fleyriat
    • Brest, Cedex, France, 29609
      • CME
    • Brest, Cedex, France, 29609
      • Hopital Augustin Morvan
    • Brive La Gaillarde, Cedex, France, 19312
      • CH de Brive la Gaillarde
    • Creteil, Cedex, France
      • Hôpital Henri Mondor
    • Le Kremlin Bicetre, Cedex, France, 94275
      • CH de Bicètre
    • Lille, Cedex, France, 59037
      • CHRU Lille - Hôpital Huriez
    • Lomme, Cedex, France, 59462
      • Hopital Saint Philibert
    • Lyon, Cedex, France, 69437
      • Hôpital Edouard Herriot
    • Marseille, Cedex, France, 13273
      • Institut J Paoli Calmettes
    • Metz, Cedex, France, 57038
      • Hopital N D Bon Secours
    • Montauban, Cedex, France, 82017
      • Clinique Pont de Chaume
    • Paris, Cedex, France, 41016
      • Hopital Saint Antoine
    • Paris, Cedex, France, 75651
      • GH Pitié Salpêtrière
    • Perpignan, Cedex, France, 66046
      • Hopital Saint Jean
    • Pessac, Cedex, France, 33604
      • Hopital de Haut Levêque
    • Poissy, Cedex, France, 78303
      • CHI Poissy Saint German en Laye
    • Quimper, Cedex, France, 29107
      • CHI de Cornouaille
    • Reims, Cedex, France, 51092
      • Hopital de La Maison Blanche
    • Saint Priest En Jarez, Cedex, France, 42271
      • Institut de Cancerologie de La Loire
    • Toulon, Cedex, France, 83056
      • Hopital Font Pré
    • Vandoeuvre Les Nancy, Cedex, France, 54511
      • Hôpitaux de Brabois
    • Vendome, Cedex, France, 41106
      • Ch De Vendome
  • Cedex 1
    • Aix En Provence, Cedex 1, France, 13616
      • CH DU Pays D Aix
    • Limoges, Cedex 1, France, 87042
      • Hôpital Dupuytren
    • Mulhouse, Cedex 1, France, 68070
      • Hôpital Emile Muller
    • Nantes, Cedex 1, France, 44093
      • Hopital Hotel Dieu Et Hme
  • Cedex 13
    • Paris, Cedex 13, France, 75651
      • GH Pitié Salpêtrière
  • Cedex 2
    • Nantes, Cedex 2, France, 44277
      • Nouvelles Cliniques Nantaises
    • Strasbourg, Cedex 2, France, 67098
      • Hôpital Hautepierre
  • Cedex 20
    • Paris, Cedex 20, France, 75970
      • Hopital Tenon
  • Cedex 3
    • Nice, Cedex 3, France, 6202
      • Hopital De L Archet
  • Cedex 4
    • Caen, Cedex 4, France, 14052
      • Clinique du Parc
  • Cedex 9
    • Angers, Cedex 9, France, 49933
      • Hotel Dieu
    • La Roche Sur Yon, Cedex 9, France, 85925
      • CH Departemental Des Oudairies
    • Rennes, Cedex 9, France, 35033
      • Hôpital Pontchaillou
    • Toulon, Cedex 9, France, 83041
      • HIA Sainte Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

See Eligibility Criteria

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation	Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation	Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy	Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)	Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)	Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Anagrelide Hydrochloride Starting Doses		6 months
Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only		6 months
Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases	6 months
Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months
Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)	Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was <=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases	6 months
Maximum Daily Dose of Anagrelide Hydrochloride		6 months

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2010
• Primary Completion (ACTUAL): December 21, 2012
• Study Completion (ACTUAL): December 21, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (ESTIMATE): September 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Thrombocytosis; Thrombocythemia, Essential
• Other Study ID Numbers: SPD422-702