Recruiting

Pacritinib

Sponsor:

Swedish Orphan Biovitrum

Code:

NCT07774455

Conditions

Myelofibrosis (MF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Not applicable- observational study

Study Details

Brief summary:

This study aims to evaluate real-world treatment patterns and effectiveness of pacritinib, including hematologic and clinical outcomes, and survival through a site-based retrospective chart review of medical records of patients with MF.

Conditions

Myelofibrosis (MF)

Study ID

NCT07774455

Start date

Aug 13, 2026

Status verified date

Sep, 2026

Completion date

Jan 27, 2027

Anticipated

Primary completion date

Jan 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients must be ≥18 years of age at the index date
  • Patients diagnosed with MF with platelet counts ≥50 x 109/L at the time of treatment initiation with pacritinib. If multiple values are available within 30 days prior to initiating treatment with pacritinib will use the value closest to index date
  • Patients will be required to have ≥1 month of treatment with pacritinib and ≥6 months of observation from the start of pacritinib unless the patient died within 6 months of starting pacritinib
  • If peripheral blasts were evaluated prior to index, they must be <10%. If not evaluated, patients will be included unless a healthcare provider has indicated in the medical record that there is a concern that the patient has transitioned to accelerated/blast phase disease at or prior to index
  • According to local regulations, waivers of consent will be sought for study patients from the appropriate regulatory authorities and/or the independent ethics committee (IEC)/institutional review board (IRB). For patients not covered by waivers of consent, signed and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age (with patient assent, as applicable), should be obtained before any study-related activities are undertaken.

Exclusion Criteria:

  • Diagnosis of acute myeloid leukemia prior to index
  • Physician-concern that the patient has transitioned to accelerated/blast phase disease if peripheral blasts were not evaluated
  • Treated with 2 or more JAK inhibitors prior to initiating treatment with pacritinib
  • Treated with pacritinib in a clinical trial setting

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Not applicable- observational study

Not Applicable - Observational Study

Primary outcome measure

  • ≥50% spleen length reduction [ Time Frame: From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months. ]
  • ≥20% spleen length reduction [ Time Frame: From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months. ]
  • Change in spleen length [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Improvement in spleen size category [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Among those with ≥1 MF-related symptom at index Symptom-specific resolution [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Among those with ≥1 MF-related symptom at index Decrease in total number of MF-symptoms [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Among those with ≥1 MF-related symptom at index Change in total number of MF-symptoms [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Change in blood counts (i.e., white blood cells [WBC], platelets, absolute neutrophil counts, peripheral blast percentage) [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Among those who are non-transfusion independent (TI) (≥1 RBC transfusion in prior 12 weeks) at index RBC-TI - absence of RBC transfusions over any 12-week period [ Time Frame: Index to Week 24 and at other timepoints, assessed up to 49 months. ]
  • Among those who are non-transfusion independent (TI) (≥1 RBC transfusion in prior 12 weeks) at index ≥50% reduction in number of RBC units transfused [ Time Frame: Index to Week 12 & Index to Week 24 ]
  • Among those who are non-transfusion independent (TI) (≥1 RBC transfusion in prior 12 weeks) at index ≥50% reduction in monthly rate of RBC units transfused [ Time Frame: Index to Week 12 & Index to Week 24 ]
  • Among those who are non-transfusion independent (TI) (≥1 RBC transfusion in prior 12 weeks) at index change in the number of RBC units transfused [ Time Frame: Index to Week 24 ]
  • Among those who are non-transfusion independent (TI) (≥1 RBC transfusion in prior 12 weeks) at index change in the monthly rate of RBC units transfused [ Time Frame: Index to Week 24 ]
  • Among those with a platelet count <100 x 109/L at index date Absolute increase in platelet counts ≥30 x 109/L without a platelet transfusion in the prior 2 days [ Time Frame: Index to best response, assessed up to 49 months. ]
  • Among patients with Hb <10 g/dL at index and who are RBC-transfusion dependent (TD) (≥3 RBC units transfused in prior 12 weeks) at index: achieved RBC-TI [ Time Frame: 12-Week Period with no RBC transfusions administered during the period ]
  • Among patients with Hb <10 g/dL at index and who are not RBC-transfusion dependent (TD) (≥3 RBC units transfused in prior 12 weeks) at index: ≥1.5 g/dL increase in average Hb [ Time Frame: 12-Week Period with no RBC transfusions administered during the period ]
  • Among patients who have IWG Hb Minor Response at index and are RBC-TD at index ≥50% reduction in RBC transfusion [ Time Frame: 12-Week Period without being fully RBC-TI ]
  • Among patients who have IWG Hb Minor Response at index and are not RBC-TD at index ≥1 g/dL increase in average Hb [ Time Frame: 12-Week Period without being fully RBC-TI ]
  • Physician-reported progression to leukemia (AML) [ Time Frame: Index to Follow-up, assessed up to 49 months. ]
  • Overall survival [ Time Frame: Index to Follow-up, assessed up to 49 months. ]
  • Leukemia-free Survival [ Time Frame: Index to Follow-up, assessed up to 49 months. ]
  • Type, dose, and number of MF-directed therapies administered [ Time Frame: At Index (Baseline) ]
  • Reasons for treatment switch from a prior MF-directed therapy to pacritinib [ Time Frame: At Index (Baseline) ]
  • Method used to switch from prior JAKi to pacritinib [ Time Frame: At Index (Baseline) ]
  • Physician reported (or Physician confirmed) JAKi withdrawal syndrome after switching to pacritinib from a different JAKi [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Pacritinib line of therapy, treatment dose and frequency, changes in dose/and or frequency, frequency of dose changes and reasons for change [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Duration of treatment with pacritinib [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Concomitant MF-related medications [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Reason for discontinuation of pacritinib [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Subsequent MF-therapy following discontinuation of pacritinib and time to next Treatment [ Time Frame: Prior to (index date) and after initiation of pacritinib (up to 49 months). ]
  • Demographic characteristics include age, sex, race/ethnicity, geographic region, and insurance type [ Time Frame: At Index (Baseline) ]
  • Body mass index (BMI) for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Receipt of allo-HSCT among patients referred to allo-HSCT [ Time Frame: Index to Week 24 ]
  • Duration of treatment with pacritinib prior to allo-HSCT [ Time Frame: Index to Week 24 ]
  • Dose of pacritinib prior to allo-HSCT [ Time Frame: Index to Week 24 ]
  • Discontinuation of pacritinib prior to allo-HSCT [ Time Frame: Index to Week 24 ]
  • Treatment with pacritinib during conditioning [ Time Frame: Index to Week 24 ]
  • Dose of pacritinib during condition [ Time Frame: Index to Week 24 ]
  • Duration of treatment with pacritinib after allo-HSCT [ Time Frame: Index to Week 24 ]
  • Dose of pacritinib after allo-HSCT [ Time Frame: Index to Week 24 ]
  • Type of MF for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Comorbidities for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • MF Risk Category for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Bone Marrow Fibrosis Grade for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Type of MF Mutations for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Variant Allele Frequency (VAF) for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Number of Driver Mutations for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Number of High-Risk Mutations for all participants enrolled [ Time Frame: At Index (Baseline) ]
  • Karyotype for all participants enrolled [ Time Frame: At Index (Baseline) ]

Central Contacts and Locations

Central contacts

IQVIA Study Team

617-621-1600PACER-study@mail.iqvia.com

Clinical Operations Lead

sara.norris@iqvia.com

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Podoltsev

nikolai.podoltsev@yale.edu

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Srisuwananukorn

andrew.srisuwananukorn@osumc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Coltoff

coltoff@musc.edu

More Information

Sponsor

Swedish Orphan Biovitrum

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Myelofibrosis
  • Pacritinib
  • Sobi
  • Sobi.PACRIT-RWE-101
  • PACER

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Swedish Orphan Biovitrum on 2026-09-14.