Combination of Tagraxofusp and Pacritinib for Myelofibrosis
This study is testing a combination of two drugs, Tagraxofusp and Pacritinib, for people with myelofibrosis (MF) that is intermediate-1 or higher. This is for patients who have already tried or cannot take approved JAK inhibitors. The goal is to see how well this combination works to shrink the spleen and improve symptoms like fatigue and pain. Tagraxofusp is given by IV infusion for 3 days, and Pacritinib is taken by mouth twice a day. The study will measure spleen size using MRI or CT scans and track symptom changes over 24 weeks. About 20 people are expected to join this study.
- Study design
- This is an open-label, single-center study, meaning everyone knows which treatment they are receiving. It aims to enroll 20 participants.
- What's involved
- You would receive Tagraxofusp by IV infusion for 3 consecutive days, and Pacritinib orally twice daily. Spleen size and symptoms will be measured up to 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured up to 24 weeks after starting treatment.
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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
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Abdulraheem Yacoub, Doctor of Medicine · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center
Who to contact
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What this trial measures
- Spleen volume reduction by MRI or CT imaging, achieving ≥ 35% reduction in spleen volume imaging from baseline to week 24.Baseline to up to 24 weeks
MRI of abdomen will be performed WITHOUT contrast. If MRI is contraindicated - CT scan will be allowed (IV contrast will be used unless contraindicated). The same type of Imaging used at screening must continue to be used throughout the study.
- Change from baseline in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score Version 2.0 (MPN-SAF TSS 2.0) to week 24.Baseline to up to 24 weeks
Improvement in symptoms: \>/= 50% reduction in Modified Total Symptom Score (mTSS) from baseline to week 24 as measured by the Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score Version 2.0 (MPN-SAF TSS 2.0). The MPN Symptom Assessment Form) includes the assessment of symptoms that are relevant to myelofibrosis. MPN-SAF was simplified to a concise and abbreviated tool called the MPN-SAF Total Symptom Score (MPN-SAF TSS), that is used for the assessment of the 10 most relevant symptoms in subjects with MPN (fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fever) in both clinical practice and clinical trial settings. The symptom severity is rated by subjects on a scale of 1 to10 MPN-SAF-TSS: a total score will be calculated by the addition of every individual symptom score. The change from baseline will be statically measured and reported.