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

Recruiting now · Phase 2

Conditions studied: KSHV Inflammatory Cytokine Syndrome (KICS), Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease

In brief

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.

Key facts

Study ID: NCT06052618
Run by: National Cancer Institute (NCI)
People needed: 75
Starts: 2025-03-17
Expected to finish: 2034-01-01
Last updated by the study team: 2026-06-01

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Grade >2 symptomatic visceral KS (except for edema or non-ulcerating disease restricted to the oral cavity).
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to pacritinib.
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Lists including medications and substances known or with the potential to interact with the specified CYP3A4 isoenzymes.
Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.
Any history of CTCAE Grade >= 3 cardiac events within the last 3 months.
QTc(Fredericia) prolongation >480 ms or other factors that increase the risk for QTc prolongation (i.e., heart failure, or a history of long QT interval syndrome).
Use of concomitant medications with significant potential for QTc prolongation
History of thrombosis, troponin-positive (Tpos) or myocardial infarction within the last 6 months
Participants with moderate (Child-Pugh Score B) or severe hepatic impairment (Child-Pugh Score C)
Diagnosis of primary effusion lymphoma [PEL] or another lymphoma.
Participants with a prior or concurrent malignancy whose natural history or treatment that has potential to interfere with the safety or efficacy assessment of the regimen.
Pregnant individuals as evaluated by a positive serum or urine beta-hCG at screening.
There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with pacritinib. Breastfeeding should be discontinued if the nursing person is treated with pacritinib.
Uncontrolled bacterial, mycobacterial, or fungal infection at screening.
Uncontrolled intercurrent illness that would limit compliance with study requirements, including results of hematology and chemistry testing, infection disease (etc.)

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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