Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
- Conditions
- Interventions
- Registration Number
- NCT06052618
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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:
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- Detailed Description
Background:
* Pacritinib, is a JAK2/tyrosine kinase 3 inhibitor with negligible activity against JAK1 that also suppresses the interleukin-1 (IL-1) directed inflammatory pathway via inhibition of interleukin 1 receptor associated kinase.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Pacritinib Treatment with pacritinib
- Primary Outcome Measures
Name Time Method Clinical benefit Prior to each cycle and at EOT and 1 year post treatment Percentage of participants with the best overall response of CR or PR to therapy.
- Secondary Outcome Measures
Name Time Method Safety of pacritinib Prior to each cycle, at EOT, and safety visit. Adverse events (AEs) will be reported by type and grade of toxicity
Effect of pacritinib on concurrent diagnosis of Kaposi sarcoma (KS) Prior to each cycle Fraction of participants who have a coexisting diagnosis of KS and who develop a response of any degree (PR; SD)
Time to treatment failure and duration of benefit Prior to each cycle and at EOT and 1 year post treatment The interval between initiating therapy and the earliest of clinical progression and and the time from to disease progression or death in patients who achieve CR, PR, or SD.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States