N/A
N=175
French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia
Essential Thrombocythemia
Bottom Line
View on ClinicalTrials.gov: NCT01192347 ↗Enrolled (actual)
175
Serious AEs
4.6%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation — 81.7 percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation |
81.7 | — |
| PRIMARY Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation |
94.9 | — |
| PRIMARY Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy |
81.3 | — |
| PRIMARY Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) |
83.5 | — |
| PRIMARY Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) |
89.2 | — |
| PRIMARY Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation |
41.7; 25.2 | — |
| PRIMARY Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation |
48.7; 38.5 | — |
| PRIMARY Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy |
25.0; 31.3 | — |
| PRIMARY Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) |
44.4; 30.8 | — |
| PRIMARY Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) |
32.4; 21.6 | — |
| SECONDARY Percentage of Subjects With Anagrelide Hydrochloride Starting Doses |
0.6; 41.1; 52.6; 0.6; 5.1 | — |
| SECONDARY Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only |
1; 7; 2; 26; 1; 109 | — |
| SECONDARY Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation |
44.3; 5.2; 16.5 | — |
| SECONDARY Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation |
51.3; 2.6; 15.4 | — |
| SECONDARY Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy |
37.5; 6.3; 12.5 | — |
| SECONDARY Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) |
39.1; 4.5; 18.8 | — |
| SECONDARY Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) |
67.6; 5.4; 5.4 | — |
| SECONDARY Maximum Daily Dose of Anagrelide Hydrochloride |
1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01192347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.