Tagraxofusp + Pacritinib for Myelofibrosis

Overseen By Victoria Guinn, B.S

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Kansas Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

Abdulraheem Yacoub, Doctor of Medicine

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Life expectancy of > 6 months

Exclusion Criteria

Simultaneously enrolled in any therapeutic clinical trial

Is pregnant or breastfeeding

Presence of peripheral blood or bone marrow blast count > 10%

What Are the Treatments Tested in This Trial?

Interventions

• Pacritinib
• Tagraxofusp

How Is the Trial Designed?

Group I: Tagrxofusp (IV) in combination with Pacritinib (Oral) Experimental Treatment 2 Interventions

Tagraxofusp Patients will receive 12 micrograms/kg of Tagraxofusp (TAG) by IV infusion once daily for 3 consecutive days. Pacritinib Pacritinib (PAC) will be given orally, 200 mg twice per day starting at C2D4 and administered continuously (Subsequent cycles start on Day 1 of the Cycle).

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+