Statin- and bisphosphonate treatment in patients with the Philadelphia-negative chronic myeloproliferative neoplasms - essential thrombocytosis, polycythemia vera and hypercellular myelofibrosis.

Phase 1

• Conditions: MedDRA version: 19.0Level: LLTClassification code 10028577Term: Myeloproliferative disorder NOSSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 100000004864; The Philadelphia-negative chronic myeloproliferative neoplasms: Essential thrombocytosis, polycythemia vera and hypercellular myelofibrosis.; MedDRA version: 19.0Level: LLTClassification code 10028576Term: Myeloproliferative disorderSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10074692Term: Post essential thrombocythaemia myelofibrosisSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 19.0Level: LLTClassification code 10028538Term: Myelofibrosis with myelometaplasiaSystem Organ Class: 100000004864; MedDRA version: 19.0Level: LLTClassification code 10015495Term: Essential thrombocytosisSystem Organ Class: 100000004864

• Registration Number: EUCTR2016-001406-42-DK
• Lead Sponsor: Hæmatologisk Afdeling, Sjælland Sygehus, Roskilde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-07
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Low-risk MPN patients
1.WHO 2016 classified ET, PV or hyperproliferativ primary myelofibrosis og prePMF (thrombocytosis and/or leukocytosis without anemia).
2.Age > 18 years.
3.Expected survival > 1 year.
4.Fulfills criteria for low-risk MPN disease:
a.Age < 60 years and
b.No prior thrombosis and
c.B-thrombocytes < 1500 x 109/l.
5.Does not use statin or bisphosphonate.

High-risk MPN patients
1.WHO 2008 classified ET, PV or hyperproliferativ primary myelofibrosis (thrombocytosis and/or leukocytosis without anemia).
2.Age > 18 years.
3.Expected survival > 1 year.
4.Fulfills criteria for high-risk MPN disease:
a.Age > 60 years or
b.Prior thrombosis or
c.B-thrombocytes > 1500 x 109/l.
5.Does not use statin or bisphosphonate.

Reactive thrombocytosis and/or leukocytosis
1.Referred on suspicion of MPNs. No suspicion of MPN disease.
2.Age > 18 years.
3.Expected survival > 1 year.
4.Does not use statin.

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

General:
1.Uncontrolled autoimmune or chronic inflammatory disease
2.Different active cancer
3.Pregnancy (in fertile women pregnancy must be ruled out by negative pregnancy test and safe contraceptive treatment must be used).

Low-risk MPN:
1.Contraindications against atorvastatin treatment
a.Active lever disease or continuous elevated transaminases of unknown reasons
b.Use of potent CYP3A4-inhibitors
c.Use of gemfibrozil or ciclosporin
d.Allergies against statins
2.Contraindications against zoledronic acid treatment
a.Severe renal failure (GFR < 35 ml/min/1,73m2)
b.Allergies against bisphosphonates

High-risk MPN:
1.Contraindications against atorvastatin treatment.
a.Active lever disease or continuous elevated transaminases of unknown reasons
b.Use of potent CYP3A4-inhibitors
c.Use of gemfibrozil or ciclosporin
d.Allergies against statins
2.Contraindications against zoledronic acid treatment
a.Severe renal failure (GFR < 35 ml/min/1,73m2)
b.Allergies against bisphosphonates
3.Contraindications against interferon treatment
a.Uncompensated lever cirrhosis, severely reduced lever function along with HIV-HCV infected patients with cirrhosis and Child-pugh > 6
b.Severe cardiac disease
c.Autoimmune hepatitis
d.Abnormal TSH (must be corrected)
e.Allergies against interferon

Reactive thrombocytosis and/or leukocytosis
1.Contraindications against atorvastatin treatment
a.Active lever disease or continuous elevated transaminases of unknown reasons
b.Use of potent CYP3A4-inhibitors
c.Use of gemfibrozil or ciclosporin
d.Allergies against statins

Study & Design

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