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NCT06414681 · ClinicalTrials.gov registry record · Early 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
A Early Phase 1 study, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT06414681 is a Early Phase 1 study that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT06414681, a Early Phase 1 study, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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
Interventions
- DRUG Pacritinib
- DRUG Tagraxofusp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06414681
The ClinicalTrials.gov registry entry for NCT06414681 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pacritinib is the first listed.
NCT06414681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06414681 about?
NCT06414681 is a clinical study titled "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". 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 inhi...
What is the current status of trial NCT06414681?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2025-08-25. Estimated completion is 2026-12.
What interventions are being tested in trial NCT06414681?
The interventions under investigation include: Pacritinib (DRUG), Tagraxofusp (DRUG).
Who is sponsoring clinical trial NCT06414681?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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