RecruitingPhase 2NCT06052618

Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)


Sponsor

National Cancer Institute (NCI)

Enrollment

75 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Kaposi sarcoma herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS) and KSHV-multicentric Castleman disease (MCD) occur in people living with HIV. These diseases cause severe inflammation that can be fatal if not treated. Objective: To test a drug (pacritinib) in people with KSHV-associated KICS or MCD. Eligibility: People aged 18 years and older with KSHV-associated KICS or MCD. They must have at least one symptom. Design: Participants will be screened. They will have a physical exam with blood tests and tests of their heart function. They will have imaging scans. Their ability to perform everyday tasks will be reviewed. In some participants who have Kaposi sarcoma (KS) with KICS or MCD, these individuals may need a bronchoscopy and/or endoscopy of the upper or lower intestine: A flexible tube with a camera and a light source will be inserted through the mouth or anus to see these structures and assess any KS. Pacritinib is a capsule taken by mouth. Participants will take the drug twice a day, every day, for up to 24 weeks. They will write down each dose in a diary. Participants will visit the clinic 3 times in the first 4 weeks. Their visits will taper to once every 4 weeks. Imaging scans, blood tests, and other tests will be repeated during these visits. Participants will give samples of saliva. They may opt to allow tissues samples to be taken from their skin and lymph nodes. Participants will have follow-up visits 7 days and 30 days after their last dose of pacritinib. After that, they will visit the clinic every 3 months for up to 1 year. The physical exam and blood, heart, and imaging tests will be repeated at these visits.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called pacritinib in patients with two rare conditions caused by the Kaposi sarcoma herpesvirus (KSHV): KSHV-associated multicentric Castleman disease (KSHV-MCD) and KSHV-associated inflammatory cytokine syndrome (KICS). Both cause severe inflammation and immune system problems. **You may be eligible if...** - You are 18 or older - You have been diagnosed with KSHV-MCD confirmed by biopsy or you meet the criteria for KICS - You have at least one symptom of the disease (fever, fatigue, nausea, cough, or respiratory problems) - You have at least one abnormal lab finding linked to the condition (anemia, low platelets, elevated inflammatory markers) **You may NOT be eligible if...** - You have a serious heart arrhythmia or other major cardiac condition - You have severe organ dysfunction - You are pregnant or breastfeeding - You have uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPacritinib

Pacritinib is administered orally as 200 mg twice daily for a total of 6, 28-day cycles


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06052618


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