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RecruitingNCT07774455PACERUpdated Oct 21, 2026

Pacritinib Effectiveness in Real-world Settings

An observational study in Myelofibrosis (MF), sponsored by Swedish Orphan Biovitrum. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Swedish Orphan Biovitrum · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 21, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a multicenter, observational, retrospective chart review study of patients with Myelofibrosis (MF) who received treatment with pacritinib in routine clinical settings with platelet count ≥50 x 109/L at the time of treatment initiation with pacritinib. This study will be conducted entirely through medical chart abstraction; all data will be taken from the patient's medical record, with no additional assessments.

02

Conditions studied

  • Myelofibrosis (MF)

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Keywords

  • Myelofibrosis
  • Pacritinib
  • Sobi
  • Sobi.PACRIT-RWE-101
  • PACER
03

In context

Primary Myelofibrosis

625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.

This study's planned enrollment of 60 is below the median of 125 across 73 observational studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Swedish Orphan Biovitrum is the lead sponsor of 82 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Browse Swedish Orphan Biovitrum studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with platelet counts ≥50 x 10\^9/L at pacritinib initiation from a total of 20-25 centers across the US over a 4-year time period (2022 to 2026).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients must be ≥18 years of age at the index date
  • Patients diagnosed with MF with 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 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • OtherNot applicable- observational study

    Not Applicable - Observational Study

06

What researchers measure

Primary outcomes

  1. ≥50% spleen length reduction

    Time frame: From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months.

  2. ≥20% spleen length reduction

    Time frame: From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months.

  3. Change in spleen length

    Time frame: Index to Week 24 and at other timepoints, assessed up to 49 months.

  4. Improvement in spleen size category

    Time frame: Index to Week 24 and at other timepoints, assessed up to 49 months.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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

  19. Physician-reported progression to leukemia (AML)

    Time frame: Index to Follow-up, assessed up to 49 months.

  20. Overall survival

    Time frame: Index to Follow-up, assessed up to 49 months.

  21. Leukemia-free Survival

    Time frame: Index to Follow-up, assessed up to 49 months.

  22. Type, dose, and number of MF-directed therapies administered

    Time frame: At Index (Baseline)

  23. Reasons for treatment switch from a prior MF-directed therapy to pacritinib

    Time frame: At Index (Baseline)

  24. Method used to switch from prior JAKi to pacritinib

    Time frame: At Index (Baseline)

  25. 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).

  26. 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).

  27. Duration of treatment with pacritinib

    Time frame: Prior to (index date) and after initiation of pacritinib (up to 49 months).

  28. Concomitant MF-related medications

    Time frame: Prior to (index date) and after initiation of pacritinib (up to 49 months).

  29. Reason for discontinuation of pacritinib

    Time frame: Prior to (index date) and after initiation of pacritinib (up to 49 months).

  30. 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).

  31. Demographic characteristics include age, sex, race/ethnicity, geographic region, and insurance type

    Time frame: At Index (Baseline)

  32. Body mass index (BMI) for all participants enrolled

    Time frame: At Index (Baseline)

  33. Receipt of allo-HSCT among patients referred to allo-HSCT

    Time frame: Index to Week 24

  34. Duration of treatment with pacritinib prior to allo-HSCT

    Time frame: Index to Week 24

  35. Dose of pacritinib prior to allo-HSCT

    Time frame: Index to Week 24

  36. Discontinuation of pacritinib prior to allo-HSCT

    Time frame: Index to Week 24

  37. Treatment with pacritinib during conditioning

    Time frame: Index to Week 24

  38. Dose of pacritinib during condition

    Time frame: Index to Week 24

  39. Duration of treatment with pacritinib after allo-HSCT

    Time frame: Index to Week 24

  40. Dose of pacritinib after allo-HSCT

    Time frame: Index to Week 24

  41. Type of MF for all participants enrolled

    Time frame: At Index (Baseline)

  42. Comorbidities for all participants enrolled

    Time frame: At Index (Baseline)

  43. MF Risk Category for all participants enrolled

    Time frame: At Index (Baseline)

  44. Bone Marrow Fibrosis Grade for all participants enrolled

    Time frame: At Index (Baseline)

  45. Type of MF Mutations for all participants enrolled

    Time frame: At Index (Baseline)

  46. Variant Allele Frequency (VAF) for all participants enrolled

    Time frame: At Index (Baseline)

  47. Number of Driver Mutations for all participants enrolled

    Time frame: At Index (Baseline)

  48. Number of High-Risk Mutations for all participants enrolled

    Time frame: At Index (Baseline)

  49. Karyotype for all participants enrolled

    Time frame: At Index (Baseline)

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added
Show 2 added (2 United States)
  • Tampa General Hospital · Tampa, United States
  • OneOncology Research Network · Nashville, United States
Oct 21, 2026
Primary completion
Jan 27, 2027→Mar 10, 2027
Oct 21, 2026
Study completion
Jan 27, 2027→Mar 10, 2027
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    2 sites added
    Show 2 added (2 United States)
    • Tampa General Hospital · Tampa, United States
    • OneOncology Research Network · Nashville, United States
    Primary completion Jan 27, 2027→Mar 10, 2027
    Study completion Jan 27, 2027→Mar 10, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07774455
Lead sponsor
Swedish Orphan Biovitrum
Collaborators
IQVIA RDS Inc.
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Aug 13, 2026
Primary completion
Mar 10, 2027 (estimated)
Completion
Mar 10, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

IQVIA Study Team
Contact
PACER-study@mail.iqvia.com
617-621-1600
Clinical Operations Lead
Contact
sara.norris@iqvia.com
Raman Garcha, MD
principal investigator · Swedish Orphan Biovitrum

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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