What this study is
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.
What's being tested
- Not applicable- observational study
Intervention · OTHER
Not Applicable - Observational Study
Study details
- Official title
- Pacritinib Effectiveness in Real-world Settings (PACER)
- Sponsor
- Swedish Orphan Biovitrum
- Conditions
- Myelofibrosis (MF)
- Enrolling
- 60 people
- Starts
- 2026-08-13
- Est. completion
- 2027-03-10
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (5)
5 openYale School of Medicine
New Haven, Connecticut, United States
- Podoltsev · Contactnikolai.podoltsev@yale.edu
RecruitingTampa General Hospital
Tampa, Florida, United States
- Gesiotto · Contact(813) 844-9575qgesiotto@tgh.org
RecruitingThe Ohio State University
Columbus, Ohio, United States
- Srisuwananukorn · Contactandrew.srisuwananukorn@osumc.edu
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- Coltoff · Contactcoltoff@musc.edu
RecruitingOneOncology Research Network
Nashville, Tennessee, United States
- Favaro · Contact(704) 342-1900jfavaro@oncologycharlotte.com
Recruiting
Study team
Sponsor
Swedish Orphan Biovitrum
Study ID Sobi.PACRIT-RWE-101
Principal investigator
Raman Garcha, MD
Swedish Orphan Biovitrum
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.