Tagraxofusp + Pacritinib for Myelofibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of two treatments, Tagraxofusp (a targeted therapy) and Pacritinib (a kinase inhibitor), for individuals with myelofibrosis (a rare bone marrow cancer) who have not found success with other treatments. The main goal is to determine if these drugs can work together to improve symptoms and assess their safety. The trial also aims to understand how the drugs affect patients' blood and track any changes in cancer-related genes. Individuals with myelofibrosis who have had limited success with JAK inhibitors might be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I need to stop my current medications for the trial?
Participants must stop taking any myelofibrosis-directed drug treatments at least 4 weeks before starting the trial, except for stable doses of glucocorticosteroids or erythropoiesis-stimulating agents. If you are on other medications, the protocol does not specify, but you should discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found tagraxofusp to be safe for patients with myelofibrosis, a type of bone marrow disorder. It did not harm the bone marrow and even improved symptoms. Some patients paused their treatment, but these interruptions were manageable.
Pacritinib, already FDA-approved for other uses, has been tested in patients with no prior treatment or those who used JAK inhibitors (drugs for blood disorders). Both tagraxofusp and pacritinib have shown manageable side effects, indicating relative safety when used together. However, as this trial remains in its early stages, further research is needed to fully understand the safety of this combination.12345Why are researchers excited about this trial's treatments for myelofibrosis?
Researchers are excited about Tagraxofusp combined with Pacritinib for myelofibrosis because it introduces a unique approach compared to existing treatments like JAK inhibitors, which are commonly used. Tagraxofusp is an innovative agent that targets CD123, a protein often overexpressed in cancer cells, offering a new mechanism of action. Pacritinib, on the other hand, is notable for its ability to be used in patients with low platelet counts, a common challenge in myelofibrosis treatment. This combination could provide a more effective option for patients, especially those who cannot tolerate current therapies.
What evidence suggests that the combination of Tagraxofusp and Pacritinib could be effective for myelofibrosis?
Research has shown that Tagraxofusp reduces tumors in patients with myelofibrosis. In one study, 40% of patients who hadn't tried other treatments experienced significant improvement. Pacritinib is known to shrink the spleen, a key issue in myelofibrosis. This trial will administer a combination of Tagraxofusp and Pacritinib, aiming to improve symptoms and outcomes by using both drugs together. Early evidence suggests this combination might offer a new option for those who haven't succeeded with other treatments.13456
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?
This trial is for adults (18+) with intermediate-2 or higher risk myelofibrosis who have already tried JAK inhibitor therapy or can't take it. Participants must have good organ function, not be pregnant or breastfeeding, and be able to follow study requirements. People with certain infections, other cancers, severe illnesses, prior use of these drugs, or recent treatments cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tagraxofusp by IV infusion once daily for 3 consecutive days and Pacritinib orally, 200 mg twice per day starting at C2D4 and administered continuously
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and symptom improvement
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Pacritinib
- Tagraxofusp
Trial Overview
The study tests a combination of two drugs—Tagraxofusp and Pacritinib—in people with advanced myelofibrosis. It aims to see how well the combo works and how safe it is. All participants receive both drugs; there’s no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
Citations
Final safety and efficacy results from a phase 1/2 study ... - PMC
In total, 30 patients treated with tagraxofusp 12 μg/kg per day were assessable for efficacy and included in the ITT population. Twenty-five (83%) had relapsed/ ...
2.
onclive.com
onclive.com/view/early-data-for-tagraxofusp-support-further-evaluation-in-combination-therapies-in-myelofibrosisEarly Data for Tagraxofusp Support Further Evaluation in ...
Tagraxofusp showed no dose-limiting toxicities and manageable safety in myelofibrosis patients, with 44% experiencing dose interruptions due to ...
NCT06414681 | Combination of Tagraxofusp with ...
The goal of this open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with ...
4.
hematologyadvisor.com
hematologyadvisor.com/news/myelofibrosis-clinical-trial-tagraxofusp-pacritinib-combo-therapy-risk/Clinical Trial Aims to Test Tagraxofusp and Pacritinib ...
The primary outcome measures will be a spleen volume reduction of 35% of more and the change in the Myeloproliferative Neoplasm Symptom ...
Final safety and efficacy results from a phase 1/2 study of ...
In patients who were treatment naïve, 40% had TSS ≥50%, and median OS was 26.6 months. In this trial, tagraxofusp monotherapy in MF was well ...
6.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/6641/528582/Pilot-Phase-II-Trial-of-the-Combination-ofPilot Phase II Trial of the Combination of Tagraxofusp with ...
Pacritinib (PAC) is an FDA approved JAK2/IRAK1/ACVR1 inhibitor that was studied in treatment naïve and JAK-inhibitor exposed patients and ...
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