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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01192347
First received: August 26, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Essential Thrombocythemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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    • Not Withdrawn: in all other cases

  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Percentage of Subjects With Anagrelide Hydrochloride Starting Doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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

  • Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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

  • Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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

  • Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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

  • Maximum Daily Dose of Anagrelide Hydrochloride [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

See Eligibility Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192347

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

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01192347     History of Changes
Other Study ID Numbers: SPD422-702
Study First Received: August 26, 2010
Results First Received: July 24, 2013
Last Updated: February 14, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Commission Nationale de L'informatique et des Libertes

Additional relevant MeSH terms:
Thrombocythemia, Essential
Thrombocytosis
Blood Coagulation Disorders
Hematologic Diseases
Blood Platelet Disorders
Myeloproliferative Disorders
Bone Marrow Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 15, 2014