Pacritinib Effectiveness in Real-world Settings
Purpose
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.
Condition
- Myelofibrosis (MF)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Retrospective
Recruiting Locations
The Ohio State University
Columbus, Ohio 43210
Columbus, Ohio 43210
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
More Details
- Status
- Recruiting
- Sponsor
- Swedish Orphan Biovitrum
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.