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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tagraxofusp
  • Pacritinib

Treatment groups

20 Participants
are divided into 1 treatment group