Atorvastatin for patients with Philadelphia-negative chronic myeloproliferative neoplasms - Essential thrombocythemia, polycythemia vera and prefibrotic myelofibrosis

Phase 1

• Conditions: Essential thrombocythemia, Polycythemia vera, prefibrotic myelofibrosis; MedDRA version: 20.0Level: PTClassification code 10077465Term: Myeloproliferative neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2022-003009-31-DK
• Lead Sponsor: Zealand University Hospital, dept. of Haematology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

WHO 2016 classified ET, PV or prePMF with thrombocytosis and/or leukocytosis.
2. Age > 18 years.
3. Expected survival > 3 years.
4. If ongoing cytoreductive treatment, this must have started > 3 months ago, and there must not be an expected change of dose or treatment type in the coming year.
5. Not taking statin beforehand

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Uncontrolled autoimmune or chronic inflammatory disorder (covers unexplained inflammatory condition, inadequately treated inflammatory condition, and treatment with strong immunosuppressive medications).
2. Other active cancer (excluding squamous cell carcinoma or basal cell carcinoma in the skin and prostate cancer treated with watchful waiting).
3. Pregnancy
4. Contraindications against starting atorvastatin:
a. Active liver disease or persistent transaminase elevation of unknown cause.
b. Concomitant use of potent CYP3A4 inhibitors
c. Combination with gemfibrozil or ciclosporin
d. Allergy to statins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified