Pacritinib Effectiveness in Real-world Settings
ConditionMyelofibrosis (MF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSwedish Orphan Biovitrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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).
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot Applicable - Observational Study
Treatment groups
No treatment groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Swedish Orphan Biovitrum
Lead sponsor
IQVIA RDS Inc.
Collaborator
Source ClinicalTrials.gov