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Essential ThrombocythemiaFOXNCT01192347

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

An observational study of Essential Thrombocythemia, run by Shire at 46 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Thrombocythemia
How many people
177 participants
Where
46 sitesFrance
Study dates
13 Sep 2010to 21 Dec 2012
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: See Eligibility Criteria

Who may be able to join

  • Patients aged 18 years and older.
  • High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
  • 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.
  • Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.

Who cannot join

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

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

France46 sites

  • CH DU Pays D Aix

    Aix-en-Provence, Cedex 1, 13616

  • Hotel Dieu

    Angers, Cedex 9, 49933

  • Ch D Arras

    Arras, Cedex, 62022

  • Hopital Robert Ballanger

    Aulnay-sous-Bois, Cedex, 93602

  • CH De Blois

    Blois, Cedex, 41016

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Ch De Fleyriat

    Bourg-en-Bresse, Cedex, 1012

  • CME

    Brest, Cedex, 29609

  • Hopital Augustin Morvan

    Brest, Cedex, 29609

  • Ch De Brive La Gaillarde

    Brive-la-Gaillarde, Cedex, 19312

  • Clinique Du Parc

    Caen, Cedex 4, 14052

  • Hopital Henri Mondor

    Créteil, Cedex

  • CH Departemental Des Oudairies

    La Roche-sur-Yon, Cedex 9, 85925

  • CH De Bicetre

    Le Kremlin-Bicêtre, Cedex, 94275

  • Hopital Robert Boulin

    Libourne, 33505

  • CHRU Lille - Hopital Huriez

    Lille, Cedex, 59037

  • Hopital Dupuytren

    Limoges, Cedex 1, 87042

  • Hopital Saint Philibert

    Lomme, Cedex, 59462

  • Hopital Edouard Herriot

    Lyon, Cedex, 69437

  • Institut J Paoli Calmettes

    Marseille, Cedex, 13273

  • CHU Nord - Chemin Des Bourrely

    Marseille, 13015

  • Hopital N D Bon Secours

    Metz, Cedex, 57038

  • CHRA

    Metz-Tessy, 74370

  • Clinique Pont de Chaume

    Montauban, Cedex, 82017

  • Hopital Emile Muller

    Mulhouse, Cedex 1, 68070

  • Hopital Hotel Dieu Et Hme

    Nantes, Cedex 1, 44093

  • Nouvelles Cliniques Nantaises

    Nantes, Cedex 2, 44277

  • Hopital De L Archet

    Nice, Cedex 3, 6202

  • GH Pitie Salpetriere

    Paris, Cedex 13, 75651

  • Hopital Tenon

    Paris, Cedex 20, 75970

  • Hopital Saint Antoine

    Paris, Cedex, 41016

  • GH Pitie Salpetriere

    Paris, Cedex, 75651

  • Hopital Saint Jean

    Perpignan, Cedex, 66046

  • Cabinet D'Hematologie

    Perpignan, 66000

  • Hopital De Haut Leveque

    Pessac, Cedex, 33604

  • CHI Poissy Saint German en Laye

    Poissy, Cedex, 78303

  • Chi De Cornouaille

    Quimper, Cedex, 29107

  • Hopital de La Maison Blanche

    Reims, Cedex, 51092

  • Hopital Pontchaillou

    Rennes, Cedex 9, 35033

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, Cedex, 42271

  • Hopital Hautepierre

    Strasbourg, Cedex 2, 67098

  • Centre De Radiotherapie

    Strasbourg, 67000

  • Hia Sainte Anne

    Toulon, Cedex 9, 83041

  • Hopital Font Pre

    Toulon, Cedex, 83056

  • Hopitaux de Brabois

    Vandœuvre-lès-Nancy, Cedex, 54511

  • Ch De Vendome

    Vendôme, Cedex, 41106

Other trials in France

About this study

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

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.

Medical subject headings
Thrombocythemia, Essential

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. 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

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. 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

    Measured: 6 months

  9. 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

    Measured: 6 months

  10. 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

    Measured: 6 months

Secondary outcomes (8)

  1. Percentage of Subjects With Anagrelide Hydrochloride Starting Doses

    Measured: 6 months

  2. Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. 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

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. Maximum Daily Dose of Anagrelide Hydrochloride

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study start13 Sep 2010
  3. Primary completion21 Dec 2012
  4. Study completion21 Dec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01192347
Sponsor's protocol ID
SPD422-702
Acronym
FOX
Status last verified
Jun 2021
First submitted
26 Aug 2010
Last updated
14 Jun 2021
Data monitoring committee
No

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.

    PubMed 24118452

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Thrombocythemia, run by Shire at 46 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01192347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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