Clinical trial • Phase IV • Haematology

ATORVASTATIN for Philadelphia-negative chronic myeloproliferative neoplasms | Essential thrombocythemia (ET) | Polycythemia vera (PV) | Prefibrotic myelofibrosis (pre-PMF)

Phase IV trial of ATORVASTATIN for Philadelphia-negative chronic myeloproliferative neoplasms | Essential thrombocythemia (ET) | Polycythemia vera (PV) |…

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Philadelphia-negative chronic myeloproliferative neoplasms | Essential thrombocythemia (ET) | Polycythemia vera (PV) | Prefibrotic myelofibrosis (pre-PMF)
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
29-10-2024

Trial design

Phase IV trial across 1 site in Denmark.

Target Sample Size
40

Eligibility

Recruits 40 No vulnerable populations selected. Trial population restricted to adults (>18 years). Informed consent is required from participants (Subject information and informed consent form (for publication) provided for adults). Assent from minors is not applicable..

Pregnancy Exclusion
3. Pregnancy
Vulnerable Population
No vulnerable populations selected. Trial population restricted to adults (>18 years). Informed consent is required from participants (Subject information and informed consent form (for publication) provided for adults). Assent from minors is not applicable.

Inclusion criteria

  • {"criterion_text":"- WHO 2016 classified ET, PV or prePMF with thrombocytosis and/or leukocytosis."}
  • {"criterion_text":"- 2. Age > 18 years."}
  • {"criterion_text":"- 3. Expected survival > 3 years."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 5. Not taking statin beforehand"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Inflammatory parameters: hs-CRP, inflammatory cytokines, leukocyte count, platelet count and neutrophil/lymphocyte ratio (NLR).","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
40
Recruitment Window Months
48
Consent Approach
Informed consent is required from adult participants. A subject information sheet and informed consent form for adults are provided (document: L1_SIS and ICF adults). No assent arrangements for minors (trial restricted to >18 years). Languages of consent documents are not specified in the available source.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Denmark

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
560
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Region Sjaelland
Department Name
Hæmatologisk afdeling
Principal Investigator Name
Hans Hasselbalch
Principal Investigator Email
hans.hasselbalch@gmail.com
Contact Person Name
Hans Hasselbalch
Contact Person Email
hans.hasselbalch@gmail.com
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Region Sjaelland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Atorvastatin 40mg Film-Coated Tablets
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketing authorisation present in IE: PA0281/236/003)
Dose Levels
40 mg
Maximum Dose
80 mg
Investigational Product Name
Atorvastatin 20mg Film-Coated Tablets
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketing authorisation present in IE: PA0281/236/002)
Dose Levels
20 mg
Maximum Dose
80 mg
Investigational Product Name
Atorvastatin 80mg Film-Coated Tablets
Active Substance
ATORVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketing authorisation present in IE: PA0281/236/004)
Dose Levels
80 mg
Maximum Dose
80 mg
Combination Treatment
Yes

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