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

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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Arm 1PacritinibTreatment with pacritinib
Primary Outcome Measures
NameTimeMethod
Clinical benefitPrior 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
NameTimeMethod
Safety of pacritinibPrior 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 benefitPrior 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

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