Actively Recruiting
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
Led by University of Kansas Medical Center · Updated on 2026-05-06
20
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and provide written informed consent
- Willingness to adhere to the study visit schedule and protocol requirements
- Male or female aged 18 years or older
- ECOG Performance Status of 0 to 2
- Life expectancy greater than 6 months
- Diagnosis of myelofibrosis meeting 2016 WHO criteria with intermediate-II or higher risk
- Clinical indications for therapy such as spleen enlargement, moderate-to-severe symptoms, or significant cytopenias
- Prior treatment with a JAK inhibitor for more than 3 months with inadequate response or contraindication
- At least 4 weeks since last dose of any myelofibrosis-directed treatment
- Not eligible for immediate allogeneic stem cell transplant
- Adequate organ, cardiac, and renal function as defined by specific laboratory and imaging criteria
- Negative pregnancy test for women of child-bearing potential within 7 days prior to treatment
- Agreement to use contraception or sexual abstinence during study and for 3 months after
You will not qualify if you...
- Participation in another therapeutic clinical trial
- Use of other anti-cancer or investigational agents during the study
- Recent treatment with chemotherapy, radiation, or biologic therapy within 14 days
- Psychiatric illness or social situation limiting compliance
- Uncontrolled infections or intercurrent illnesses
- Contraindications deemed high risk by investigator
- Pregnancy or breastfeeding
- Known allergy to study drug components
- Active severe infections within 2 weeks prior to treatment
- Prior therapy with Tagraxofusp or Pacritinib
- Peripheral blood or bone marrow blasts over 10%
- Active graft versus host disease or recent immunosuppressive treatment for it
- Other uncontrolled active malignancies or recent cancer history with high recurrence risk
- Significant cardiovascular disease or uncontrolled hypertension
- Gastrointestinal or metabolic conditions interfering with oral drug absorption
- Persistent significant toxicities from previous therapies
- Uncontrolled pulmonary disease
- Known or suspected active central nervous system disease
- Use of strong/moderate CYP3A4 inhibitors or inducers not discontinued 14 days prior
- Use of full-dose anticoagulation or certain antiplatelet therapies within 14 days
- Recent significant bleeding events
- Active uncontrolled diarrhea or inflammatory bowel disease
- Known positivity for hepatitis A, B, C, or HIV
- Moderate or severe hepatic impairment
- Severe kidney impairment (eGFR below 30 mL/min)
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66204
Actively Recruiting
Research Team
K
KUCC Navigation
CONTACT
V
Victoria Guinn, B.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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