Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosi… (NCT06414681) | Clinical Trial Compass
RecruitingEarly Phase 1
Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined
United States20 participantsStarted 2025-08-25
Plain-language summary
The goal of this open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with intermediate-II or higher myelofibrosis (MF), who have had prior therapy with the approved JAK1/2 inhibitor or in which therapy with the approved JAK1/2 inhibitors is not appropriate, contraindicated or declined by the subjects.
The Primary Objective is to:
1\. Characterized efficacy of the combination of Tagraxofusp and Pacritinib.
The Secondary Objective is to:
1\. characterize the safety profile of the combination Tagraxofusp and Pacritinib.
2, Characterize the feasibility of the combination Tagraxofusp and Pacritinib. 3. Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib.
4\. Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms.
Exploratory:
Pharmacokinetic (PK) testing of Tagraxofusp and Pacritinib to assess clinical predictors of response.
Next Generation Sequencing (NGS) Testing to define the number and the allele burden of pathological mutations, as well as the changes over the course of therapy, both in regard to progression and response.
Blood will be collected and stored at KU BRCF for future study related PK analysis
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
✓. The participant or LAR has signed informed consent prior to initiation of any study-specific procedures or treatment.
✓. The patient is able to adhere to the study visit schedule and other protocol requirements.
✓. Males and females age ≥ 18 years.
✓. ECOG Performance Status 0 - 2 (Appendix A).
✓. Life expectancy of \> 6 months.
✓. Patient meets the 2016 WHO diagnostic criteria for MF and has an IPSS/DIPSS/DIPSS-plus intermediate-II or higher-risk disease.
✓. Patients who have indications for therapy per investigator or patient's choice, such as Splenomegaly, \>5 CM BCM or mTSS ≥ 8 or mTSS Itching, night sweats, or bone pain ≥ 5 or Significant cytopenias including Hgb \<10 g/dl, Platelet count less than 75 k/UL
Exclusion criteria
What they're measuring
1
Spleen volume reduction by MRI or CT imaging, achieving ≥ 35% reduction in spleen volume imaging from baseline to week 24.
Timeframe: Baseline to up to 24 weeks
2
Change from baseline in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score Version 2.0 (MPN-SAF TSS 2.0) to week 24.
. Simultaneously enrolled in any therapeutic clinical trial
✕. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study.
✕. The patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
✕. The patient has received treatment with another investigational agent within 14 days of study entry.
✕. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements.
✕. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation.
✕. Any condition or other contraindication to therapy as deemed by the principal investigator to place the subject at an unacceptably high risk for toxicities.