NCT01192347: FOX

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

Completed Results posted Last updated 14 June 2021

What this trial tests

trial in Essential Thrombocythemia in 177 participants. Completed in 21 December 2012.

Timeline

13 September 2010

Primary endpoint
21 December 2012

21 December 2012

Quick facts

Lead sponsor	Shire
Status	Completed
Study type	OBSERVATIONAL
Enrollment	177
Start date	13 September 2010
Primary completion	21 December 2012
Estimated completion	21 December 2012
Sites	46 locations across France

Conditions studied

• Essential Thrombocythemia — all drugs for Essential Thrombocythemia →

Sponsor

Shire — full company profile →

Who can join

18 and older, any sex, with Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation Primary · 6 months

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was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases

Group	Value	95% CI
Anagrelide Hydrochloride	81.7	73.5 – 88.3

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation Primary · 6 months

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

Group	Value	95% CI
Anagrelide Hydrochloride	94.9	82.7 – 99.4

Percentage of Subjects With Anagrelide Hydrochloride Starting Doses Secondary · 6 months

0.3 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	0.6

0.5 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	41.1

1.0 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	52.6

1.3 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	0.6

1.5 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	5.1

Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only Secondary · 6 months

-1.0 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	1

-0.5 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	7

-0.2 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	2

No change

Group	Value	95% CI
Anagrelide Hydrochloride	26

+0.2 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	1

+0.5 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	109

+1.0 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	12

+1.2 mg/day

Group	Value	95% CI
Anagrelide Hydrochloride	1

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy Primary · 6 months

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

Group	Value	95% CI
Anagrelide Hydrochloride	81.3	54.4 – 96.0

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) Primary · 6 months

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

Group	Value	95% CI
Anagrelide Hydrochloride	83.5	76.0 – 89.3

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) Primary · 6 months

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

Group	Value	95% CI
Anagrelide Hydrochloride	89.2	74.6 – 97.0

Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation Primary · 6 months

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 t

Full response

Group	Value	95% CI
Anagrelide Hydrochloride	41.7	32.6 – 51.3

Partial response

Group	Value	95% CI
Anagrelide Hydrochloride	25.2	17.6 – 34.2

Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation Primary · 6 months

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 t

Full response

Group	Value	95% CI
Anagrelide Hydrochloride	48.7	32.4 – 65.2

Partial response

Group	Value	95% CI
Anagrelide Hydrochloride	38.5	23.4 – 55.4

Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy Primary · 6 months

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 t

Full response

Group	Value	95% CI
Anagrelide Hydrochloride	25.0	7.3 – 52.4

Partial response

Group	Value	95% CI
Anagrelide Hydrochloride	31.3	11.0 – 58.7

Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) Primary · 6 months

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

Full response

Group	Value	95% CI
Anagrelide Hydrochloride	44.4	35.8 – 53.2

Partial response

Group	Value	95% CI
Anagrelide Hydrochloride	30.8	23.1 – 39.4

Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) Primary · 6 months

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

Full response

Group	Value	95% CI
Anagrelide Hydrochloride	32.4	18.0 – 49.8

Partial response

Group	Value	95% CI
Anagrelide Hydrochloride	21.6	9.8 – 38.2

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anagrelide Hydrochloride

Serious: 8/175 (5%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Anagrelide Hydrochloride
Hypertensive crisis	Vascular disorders	—
Anemia	Blood and lymphatic system disorders	—
Angina pectoris	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Palpitations	Cardiac disorders	—
Cerebrovascular accident	Nervous system disorders	—
Headache	Nervous system disorders	—
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Anagrelide Hydrochloride
Palpitations	Cardiac disorders	—
Headache	Nervous system disorders	—
Diarrhea	Gastrointestinal disorders	—
Asthenia	General disorders	—
Tachycardia	Cardiac disorders	—
Abdominal pain	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Anemia	Blood and lymphatic system disorders	—
Edema peripheral	Cardiac disorders	—
Tinnitis	Ear and labyrinth disorders	—

Most-reported serious reactions: Hypertensive crisis, Anemia, Angina pectoris, Cardiac failure, Palpitations, Cerebrovascular accident, Headache, Pulmonary arterial hypertension.

Data from ClinicalTrials.gov NCT01192347 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rey J, Viallard JF, Keddad K, Smith J, et al · · 2014 · cited 4× · PMID 24118452 · DOI 10.1111/ejh.12210
2. 44° Congress of the Italian Society of Hematology Verona, Italy, October 20–23, 2013
   · 2013
3. 18th Congress of the European Hematology Association, Stockholm, Sweden, June 13–16, 2013
   · 2013