Atorvastatinbehandling til patienter med de Philadelphia-negative kronisk myeloproliferative neoplasier - essentiel trombocytose, polycythemia vera og præfibrotisk myelofibrose.

2024-518267-35-00 Protocol HH007 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 10 Jun 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol HH007

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 40
Countries 1
Sites 1

Blod cancer

1. In patients with MPNs undergoing Best Available Therapy (BAT), to investigate the effect of adjuvant treatment with atorvastatin assessed by inflammatory markers and cell counts.

Key facts

Sponsor
Region Sjaelland
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration
10 Jun 2025 → ongoing
Decision date (initial)
2024-10-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518267-35-00
EudraCT number
2022-003009-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

1. In patients with MPNs undergoing Best Available Therapy (BAT), to investigate the effect of adjuvant treatment with atorvastatin assessed by inflammatory markers and cell counts.

Secondary objectives 1

  1. 2. To asses biochemical markers for inflammation and disease burden in a population of MPN patients who are followed prospectively during statin treatment, as well as to assess the relationship to the development of symptoms, thrombosis and transformation to myelofibrosis and AML. 3. To asses the thrombophilia profile in MPN patients before and during atorvastatin treatment. 4. To asses the number and functionality of circulating immune cells before and during atorvastatin treatment. 5. To investigate the effect of statins on the gut microbiome and possible correlations in treatment response.

Conditions and MedDRA coding

Blod cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. 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

Exclusion criteria 1

  1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 1. Inflammatory parameters: hs-CRP, inflammatory cytokines, leukocyte count, platelet count and neutrophil/lymphocyte ratio (NLR).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Atorvastatin 40mg Film-Coated Tablets

PRD8683177 · Product

Active substance
Atorvastatin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
13440 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
C10AA05 — ATORVASTATIN
Marketing authorisation
PA0281/236/003
MA holder
PINEWOOD LABORATORIES LIMITED
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Atorvastatin 80mg Film-Coated Tablets

PRD8683179 · Product

Active substance
Atorvastatin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
13440 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
C10AA05 — ATORVASTATIN
Marketing authorisation
PA0281/236/004
MA holder
PINEWOOD LABORATORIES LIMITED
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Atorvastatin 20mg Film-Coated Tablets

PRD8683175 · Product

Active substance
Atorvastatin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
13440 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
C10AA05 — ATORVASTATIN
Marketing authorisation
PA0281/236/002
MA holder
PINEWOOD LABORATORIES LIMITED
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

14 Total trials 7 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Region Sjaelland
Address
Sygehusvej 10
City
Roskilde
Postcode
4000
Country
Denmark

Scientific contact point

Organisation
Region Sjaelland
Contact name
Sponsor/PI Hans Hasselbalch

Public contact point

Organisation
Region Sjaelland
Contact name
Haematologisk afdeling SUH

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 40 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Region Sjaelland
Hæmatologisk afdeling, Sygehusvej 10, 4000, Roskilde

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-06-10 2025-08-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-518267-35-00 1.5
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1.5
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Atorvastatin 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-16 Denmark Acceptable
2024-10-25
 2024-10-29
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-02-25 Denmark Acceptable
2024-10-25
 2025-02-25
3 NON SUBSTANTIAL MODIFICATION NSM-2 2026-05-06 Denmark Acceptable
2024-10-25
 2026-05-06