Pacritinib Effectiveness in Real-world Settings
← catalyst calendarNCT07774455 · readout in 160 d
Sponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →. With IQVIA RDS Inc..
Phase
—
Status
Not yet recruiting
Study type
Observational
Enrollment
60estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-01 | estimated | When the study began enrolling |
| Primary completion | 2027-01-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-27 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelofibrosis (MF)
Intervention
- Other: Not applicable- observational study
Primary outcomes
what the primary-completion date above is the date OF≥50% spleen length reduction
measured From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months.
≥20% spleen length reduction
measured From the Index Date to Week 24 or best response in spleen reduction, assessed up to 49 months.
Change in spleen length
measured Index to Week 24 and at other timepoints, assessed up to 49 months.
Improvement in spleen size category
measured 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
measured 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
measured 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
measured 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)
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 12-Week Period without being fully RBC-TI
Physician-reported progression to leukemia (AML)
measured Index to Follow-up, assessed up to 49 months.
Overall survival
measured Index to Follow-up, assessed up to 49 months.
Leukemia-free Survival
measured Index to Follow-up, assessed up to 49 months.
Type, dose, and number of MF-directed therapies administered
measured At Index (Baseline)
Reasons for treatment switch from a prior MF-directed therapy to pacritinib
measured At Index (Baseline)
Method used to switch from prior JAKi to pacritinib
measured At Index (Baseline)
Physician reported (or Physician confirmed) JAKi withdrawal syndrome after switching to pacritinib from a different JAKi
measured 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
measured Prior to (index date) and after initiation of pacritinib (up to 49 months).
Duration of treatment with pacritinib
measured Prior to (index date) and after initiation of pacritinib (up to 49 months).
Concomitant MF-related medications
measured Prior to (index date) and after initiation of pacritinib (up to 49 months).
Reason for discontinuation of pacritinib
measured 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
measured 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
measured At Index (Baseline)
Body mass index (BMI) for all participants enrolled
measured At Index (Baseline)
Receipt of allo-HSCT among patients referred to allo-HSCT
measured Index to Week 24
Duration of treatment with pacritinib prior to allo-HSCT
measured Index to Week 24
Dose of pacritinib prior to allo-HSCT
measured Index to Week 24
Discontinuation of pacritinib prior to allo-HSCT
measured Index to Week 24
Treatment with pacritinib during conditioning
measured Index to Week 24
Dose of pacritinib during condition
measured Index to Week 24
Duration of treatment with pacritinib after allo-HSCT
measured Index to Week 24
Dose of pacritinib after allo-HSCT
measured Index to Week 24
Type of MF for all participants enrolled
measured At Index (Baseline)
Comorbidities for all participants enrolled
measured At Index (Baseline)
MF Risk Category for all participants enrolled
measured At Index (Baseline)
Bone Marrow Fibrosis Grade for all participants enrolled
measured At Index (Baseline)
Type of MF Mutations for all participants enrolled
measured At Index (Baseline)
Variant Allele Frequency (VAF) for all participants enrolled
measured At Index (Baseline)
Number of Driver Mutations for all participants enrolled
measured At Index (Baseline)
Number of High-Risk Mutations for all participants enrolled
measured At Index (Baseline)
Karyotype for all participants enrolled
measured At Index (Baseline)
Permalink · SOBI.ST's whole pipeline · Catalyst calendar · Every registered study · What changed