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Myelofibrosis,MFPhase 2PACRIMYELNCT07394153

Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia

A Phase 2 study testing Pacritinib in people with Myelofibrosis,MF, run by Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas at 13 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

We hypothesize that pacritinib leads to modification of the myelofibrosis (MF) disease phenotype, especially related to BM fibrosis and cytopenias; due potentially to its dual effect as an inhibitor of the JAK and NFκB pathways, through its targets JAK2 and IRAK1 respectively, leading to a decrease of inflammatory… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis,MF
What is being tested?
Pacritinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
13 sitesSpain
Study dates
15 Apr 2026to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written and voluntary informed consent.
  • Age ≥18 years
  • Patients with a confirmed diagnosis of myelofibrosis, either primary myelofibrosis (PMF) or post polycythemia vera (PPV-MF) or post essential thrombocythemia (PET-MF).
  • Patients with thrombocytopenia, delimited by platelets counts between 50 - 120 x 109/L.
  • Patients who require JAK-2 inhibitor therapy in the opinion of the investigator and are eligible to start treatment with pacritinib either in the first line (JAK2 inhibitor-naive) or in second line setting (after no response or loss of response or intolerance to one prior JAK2 inhibitor ).
  • Note: patients should have recovered to grade ≤ 1 from any toxicity from previous treatment.
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  • Have a Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 - 2.
  • Have a dynamic international prognostic scoring system (DIPSS) Intermediate-1, Intermediate-2, or High risk.
  • Peripheral blasts count < 5% and absolute neutrophil count (ANC) of ≥500/μL.
  • Adequate liver and renal function, defined by:
  • liver transaminases, including alanine aminotransferase (ALT or GOT) and aspartate aminotransferase (AST or GOT) ≤ 3 x upper limit normal (ULN). AST/ALT ≤5 × ULN if transaminase elevation is related to MF.
  • Total bilirubin and/or direct bilirubin ≤ 4 x ULN.
  • Estimated glomerular filtration rate (eGFR) > 30 mL/min.
  • Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × ULN.
  • If fertile, willing to use effective birth control methods during the study and up to 30 days after the last dose of pacritinib.
  • Willing to undergo and able to tolerate frequent MRI during the study and BM biopsy
  • Able to understand and willing to complete symptom assessments.

Who cannot join

  • Life expectancy <6 months.
  • Splenic irradiation within the last 6 months.
  • Previously treated with pacritinib.
  • Concurrent enrollment in another interventional trial.
  • Treatment with an experimental therapy within 28 days prior to the first dose of study treatment.
  • Systemic treatment with a strong CYP3A4 inhibitor or inducer and the treatment cannot be either discontinued or switched to a different medication within 5 half-lifes prior to study entry.
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  • Severe (Child-Pugh C) liver impairment.
  • Significant recent bleeding history defined as NCI CTCAE grade ≥2 within 3 months prior to first dose of study treatment, or with active bleeding, unless precipitated by an inciting event (e.g., surgery, trauma, or injury).
  • Conditions or medications that increase the risk of bleeding, except for aspirin (dosages of ≤100 mg per day). Patients treated with "direct-acting oral anticoagulants (DOACs), could be considered for inclusion (may be consulted with the Sponsor, GEMFIN).
  • Any history of CTCAE grade ≥2 dysrhythmias or non-dysrhythmia cardiac conditions within 6 months prior to the first dose of study treatment. Patients with non-dysrhythmia or non-QTc grade 2 cardiovascular conditions , may be considered for inclusion, if stable , asymptomatic and unlikely to affect patient safety.
  • QT corrected by the Fridericia method (QTcF) prolongation >480 ms or other factors that increase the risk for QTcF interval prolongation (e.g., heart failure, hypokalemia or history of long QT interval syndrome).
  • New York Heart Association Class II, III, or IV congestive heart failure.
  • Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's disease, inflammatory bowel disease, chronic diarrhea or constipation
  • Other malignancy within 3 years prior to treatment Day 1, other than curatively treated basal cell or squamous cell skin or corneal cancer; curatively treated carcinoma in situ of the cervix. The exception is if patients have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy.
  • Known seropositivity for human immunodeficiency virus. Known active hepatitis B, or C virus infection.
  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements.
  • Any active GI or metabolic condition that could interfere with absorption of oral medication.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

A Responsible Person Designated by the sponsor, M.D., PhD. contact

0034934344412

investigacio@mfar.net

GEMFIN Secretary contact

0034934344412

secretaria@gemfin.org

13 sites in 1 country

Spain13 sites, 13 recruiting
  • Hospital del Mar Barcelona

    Barcelona, Barcelona, 08003

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario Vall d´Hebron

    Barcelona, Barcelona, 08035

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario de Jerez

    Jerez de la Frontera, Cádiz, 11407

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28007

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Fundación Jimenez Díaz

    Madrid, Madrid, 28040

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital General Universitario Morales Meseguer

    Murcia, Murcia, 30008

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario de Salamanca

    Salamanca, Salamanca, 37007

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Clínico Universitario Valencia

    Valencia, Valencia, 46010

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Recruiting
  • Hospital Universitario Doctor Peset

    Valencia, Valencia, 46017

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

    Not yet recruiting

Other trials in Spain

About this study

Official title: Pacritinib For The Reduction Of Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia; A Multicenter, Open-Label, Single Arm, Phase II Exploratory Study

We hypothesize that pacritinib leads to modification of the myelofibrosis (MF) disease phenotype, especially related to BM fibrosis and cytopenias; due potentially to its dual effect as an inhibitor of the JAK and NFκB pathways, through its targets JAK2 and IRAK1 respectively, leading to a decrease of inflammatory cytokines and/or effects on stem/progenitor populations restoring hematopoiesis New evidence suggests that blocking simultaneously the JAK/STAT and NF-κB pathways might have a beneficial effect on aspects that only inhibition of the JAK pathway cannot achieve: partial recovery of BM histology and

PACRIMYEL is a multicenter, open-label, single arm, phase II, exploratory study including patients with MF and platelet count between 50 - 120 x 109/L. Clinic visits will occur on weeks 4, 8, 12, 24, 36 and 52 during the first year and every 12 weeks during the second year of the treatment, and pacritinib will be dispensed at every visit to the clinic.

Read more

Bone fibrosis will be assessed by biopsy and MRI imaging [mDixon Quant "(Philips), IDEAL IQ (General Electric) or qDixon (Siemens)] on weeks 24 and 52 after the first dose of study treatment. Splenomegaly and SVR (Splenic Volume Reduction) will be assessed by physical exam and MRI imaging on weeks 24 and 52 after the first dose of study treatment if splenomegaly at diagnosis. Same MRI to evaluate BM imaging will be used to measure spleen volume. Additionally, spleen size will be assessed by physical exam during the routine clinic visits. All patients should complete all efficacy assessments through Week 52, including patients who stop study treatment or have protocol-defined progressive disease prior to Week 24 and 52, unless the patient withdraws consent or dies. For patients who discontinue treatment before disease assessments on week 24 and week 52 for other reasons different than protocol-based progression of the disease (i.e. toxicity), and with no recent disease / fibrosis assessment (last BM biopsy > 12 weeks), disease and fibrosis assessments will be performed by the end of treatment visit. The trial includes the assessment of safety (AEs, comorbidities) throughout the study period at every visit.

Patient-reported symptoms through MPN-SAF TSS 2.0 will be collected screening, baseline (C1D1), and on Week 12, Week 24, Week 36, Week 52 and in 12-weeks intervals during the second year. Blood samples for translational research will be collected at screening and at week 24 for determination of cytokines.

Being tested
Pacritinib
Keywords
Myelofibrosis, JAK2 inhibitor, FTL3 inhibitor, pacritinib, low platelet count, IRAK1 inhibitor, Philadelphia Chromosome-negative Chronic Myeloproliferative Neoplasms, Bone fibrosis
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PacritinibDrug

    All patients enrolled will receive pacritinib 200 mg twice a day (BID). The maximum daily dose will be 400 mg of pacritinib. Pacritinib dose may be reduced by one level to 100 mg BID (200 mg total daily dose), or by two levels to 100 mg once daily (QD) for management of AEs. The treatment will be continued until progressive disease, unacceptable toxic effects, the patient no longer derives benefit from treatment, patients consent withdrawal or death, whichever occurs first.

Study groups in NCT07394153
Study groupRoleWhat they receive
PACRIMYELExperimentalPacritinib administed 200 mg twice a day (BID)
Receives: Drug: Pacritinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in reticulin fibrosis in bone marrow (BM)

    Measured in BM biopsy. Percentage of patients who experience a decrease of ≥1 grade in reticulin fibrosis from baseline to week 52. Definition of BM fibrosis grade will follow the European consensus that ranges from 0 (scattered, less fibrotic) to 3 (difuse and dense reticulin, more fibrotic). Patients will be classified as improvement (fibrosis decrease ≥1 grade), no change, or worsening (fibrosis increase > 1 grade).

    Measured: from baseline to week 52 after first dose of study treatment

Secondary outcomes (9)
  1. Improvement in BM fat fraction (FF)

    measured by quantitative quantitative Dixon Quant MRI or equivalent. Changes in the bone marrow associated with MF, such as replacement of the bone marrow fat by fibrosis or elevated numbers of hematopoietic cells, reduce the abundance of fat. Here we will report the percentage of patient who had an improvement in the FF (increase from baseline at week 52).

    Measured: from baseline to week 52 after first dose of study treatment

  2. red blood cell (RBC) transfusion independence

    Percentage of patients who achieved no need of RBC transfusions during at least 12 week.

    RBC transfusion independence will be reported in subgroup of patients with the changes in the Bone Marrow (by MRI and/or BM biopsy) over the first 24 and 52 weeks of treatment.

    Measured: from baseline to week 24 and week 52 after first dose of study treatment

  3. Improvement in hemoglobin level

    Percentage of patients who improve their hemoglobin levels without transfusion. Improvement was defined as a ≥ 1.5 g/dL increase in hemoglobin from baseline.

    Changes in hemoglobin level without transfusion will be reported in subgroup of patients with the changes in the Bone Marrow (by MRI and/or BM biopsy) over the first 24 and 52 weeks of treatment.

    Measured: from baseline to week 24 and week 52 after first dose of study treatment

  4. Improvement in platelet counts

    increase of platelet count (without transfusions) in comparison to baseline of above 75 x 109/L (if platelet count was between 50 - 75 109/L at baseline) or above 100 x 109/L (if platelet count was between 75 - 100 x 109/L at baseline). Alternatively, the proportion of patients who increase platelet counts ≥25% above baseline will be measured.

    Measured: from baseline to week 24 and week 52 after first dose of study treatment

  5. Myeloproliferative neoplasms (MPN) driver-gen Variant Allele Frequency (VAF)

    JAK2, CALR, and MPL genes are drivers of myelofibrosis. Their VAF could be quantified in peripheral blood or bone marrow and its circulating levels are usually correlated with the course of the disease. We aim to find the percentage of patients who reduced their VAF at week 24 and 52.

    Measured: Baseline and at Week 24 and Week 52 after the first dose of study treatment

  6. Cummulative dose

    the sum of all doses of pacritinib taken from the start of study treatment, taken into consideration interruptions and reductions.

    Measured: Throughout the study period, up to approximately 2 years

  7. Actual dose of pacritinib

    defined as the real average daily dose administered. For its calculation, the cumulative dose will be divided by the duration of the treatment, considering also the interruption periods.

    Measured: Throughout the study period, up to approximately 2 years

  8. Relative dose intensity of pacritinib

    Defined as the percentage of the planned dose that has been actually administered. Calculated dividing actual dose by planned dose per day.

    Measured: Throughout the study period, up to approximately 2 years

  9. Frequency of treatment-related adverse events

    number of patients who experience a treatment-related adverse event. Events will be classified and graded according to National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) version 5.0

    Measured: Throughout the study period, up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start15 Apr 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394153
Sponsor's protocol ID
GEMFIN-MF-PACRI 2401
Other IDs
2025-522509-39-00, 2025
Acronym
PACRIMYEL
Status last verified
Oct 2026
First submitted
2 Feb 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pacritinib in people with Myelofibrosis,MF, run by Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas at 13 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact A Responsible Person Designated by the sponsor, M.D., PhD. (0034934344412, investigacio@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in reticulin fibrosis in bone marrow (BM) (time frame: from baseline to week 52 after first dose of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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