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

NCT01192347 | Completed Results

• 1 other identifier: SPD422-702
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 46

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.

Conditions

Essential Thrombocythemia

Outcome Measures

Primary Outcomes (10)

• 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was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases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was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases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 Outcomes (8)

• 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

  6 months

• Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation

  6 months

• Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See Eligibility Criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (46)

GH Pitie Salpetriere

Paris, Cedex 13, 75651, France

Location

CH DU Pays D Aix

Aix-en-Provence, Cedex 1, 13616, France

Location

Hopital Dupuytren

Limoges, Cedex 1, 87042, France

Location

Hopital Emile Muller

Mulhouse, Cedex 1, 68070, France

Location

Hopital Hotel Dieu Et Hme

Nantes, Cedex 1, 44093, France

Location

Hopital Tenon

Paris, Cedex 20, 75970, France

Location

Nouvelles Cliniques Nantaises

Nantes, Cedex 2, 44277, France

Location

Hopital Hautepierre

Strasbourg, Cedex 2, 67098, France

Location

Hopital De L Archet

Nice, Cedex 3, 6202, France

Location

Clinique Du Parc

Caen, Cedex 4, 14052, France

Location

Hotel Dieu

Angers, Cedex 9, 49933, France

Location

CH Departemental Des Oudairies

La Roche-sur-Yon, Cedex 9, 85925, France

Location

Hopital Pontchaillou

Rennes, Cedex 9, 35033, France

Location

Hia Sainte Anne

Toulon, Cedex 9, 83041, France

Location

Ch D Arras

Arras, Cedex, 62022, France

Location

Hopital Robert Ballanger

Aulnay-sous-Bois, Cedex, 93602, France

Location

CH De Blois

Blois, Cedex, 41016, France

Location

Ch De Fleyriat

Bourg-en-Bresse, Cedex, 1012, France

Location

CME

Brest, Cedex, 29609, France

Location

Hopital Augustin Morvan

Brest, Cedex, 29609, France

Location

Ch De Brive La Gaillarde

Brive-la-Gaillarde, Cedex, 19312, France

Location

Hopital Henri Mondor

Créteil, Cedex, France

Location

CH De Bicetre

Le Kremlin-Bicêtre, Cedex, 94275, France

Location

CHRU Lille - Hopital Huriez

Lille, Cedex, 59037, France

Location

Hopital Saint Philibert

Lomme, Cedex, 59462, France

Location

Hopital Edouard Herriot

Lyon, Cedex, 69437, France

Location

Institut J Paoli Calmettes

Marseille, Cedex, 13273, France

Location

Hopital N D Bon Secours

Metz, Cedex, 57038, France

Location

Clinique Pont de Chaume

Montauban, Cedex, 82017, France

Location

Hopital Saint Antoine

Paris, Cedex, 41016, France

Location

GH Pitie Salpetriere

Paris, Cedex, 75651, France

Location

Hopital Saint Jean

Perpignan, Cedex, 66046, France

Location

Hopital De Haut Leveque

Pessac, Cedex, 33604, France

Location

CHI Poissy Saint German en Laye

Poissy, Cedex, 78303, France

Location

Chi De Cornouaille

Quimper, Cedex, 29107, France

Location

Hopital de La Maison Blanche

Reims, Cedex, 51092, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, Cedex, 42271, France

Location

Hopital Font Pre

Toulon, Cedex, 83056, France

Location

Hopitaux de Brabois

Vandœuvre-lès-Nancy, Cedex, 54511, France

Location

Ch De Vendome

Vendôme, Cedex, 41106, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Hopital Robert Boulin

Libourne, 33505, France

Location

CHU Nord - Chemin Des Bourrely

Marseille, 13015, France

Location

CHRA

Metz-Tessy, 74370, France

Location

Cabinet D'Hematologie

Perpignan, 66000, France

Location

Centre De Radiotherapie

Strasbourg, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 24118452 DERIVED

MeSH Terms

Conditions

Thrombocythemia, Essential

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 1, 2010
• Study Start: September 13, 2010
• Primary Completion: December 21, 2012
• Study Completion: December 21, 2012
• Last Updated: June 14, 2021
• Results First Posted: September 25, 2013

Record last verified: 2021-06

Locations

FR (46)