NCT07774455 · Swedish Orphan Biovitrum
Pacritinib Effectiveness in Real-world Settings
(PACER)
What this study is about
This study aims to evaluate real-world treatment patterns and effectiveness of pacritinib, including hematologic and clinical outcomes, and survival through a site-based reviewing past data chart review of medical records of patients with MF.
View original scientific description
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.
Interventions
OTHER
Not applicable- observational study
Not Applicable - Observational Study
Primary outcome measures
≥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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
- Columbus, Ohio
- Charleston, South Carolina
Collaborators
IQVIA RDS Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations