Actively Recruiting
Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
Led by National Cancer Institute (NCI) · Updated on 2026-05-11
75
Participants Needed
1
Research Sites
458 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have KSHV-associated inflammatory cytokine syndrome (KICS) or confirmed Kaposi sarcoma herpesvirus-multicentric Castleman disease (KSHV-MCD)
- Age 18 years or older
- Have at least one clinical symptom related to KSHV-MCD or KICS such as fever, fatigue, gastrointestinal or respiratory symptoms
- Have at least one laboratory abnormality related to KSHV-MCD or KICS such as anemia, thrombocytopenia, hypoalbuminemia, or elevated C-reactive protein
- No life- or organ-threatening manifestations of KSHV-MCD, KICS, or Kaposi Sarcoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Liver and kidney function within specified limits
- HIV-positive participants must be willing to continue or start effective antiretroviral therapy that does not strongly interact with CYP3A4
- Participants with chronic hepatitis B must be on suppressive therapy
- Participants with hepatitis C must have completed treatment with sustained response for at least 3 months
- Prior therapy for KSHV-MCD or KICS must have a washout period of at least 3 weeks
- Medications that substitute strong CYP3A4 inhibitors require a washout of at least 5 half-lives before enrollment
- Individuals able to become pregnant or father a child must agree to use highly effective contraception before, during, and for 30 days after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Symptomatic visceral Kaposi Sarcoma greater than Grade 2 except certain mild cases
- History of allergic reaction to pacritinib or similar compounds
- Use of strong CYP3A4 inhibitors or inducers
- Ongoing or recent severe bleeding or hemorrhage
- Recent serious cardiac events or conditions increasing risk of QT prolongation
- Use of medications that may prolong QT interval
- Recent history of thrombosis or myocardial infarction
- Moderate to severe liver impairment
- Diagnosis of primary effusion lymphoma or other lymphoma
- Prior or concurrent malignancy that interferes with safety or efficacy assessments
- Pregnant or breastfeeding individuals
- Uncontrolled infections or illnesses that limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
National Cancer Institute Referral Offic
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here