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Tyrosine Kinase Inhibitor
Pacritinib for Castleman Disease and Syndrome
Phase 2
Recruiting
Led By Ramya M Ramaswami, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group [ECOG] performance status <= 3 (Karnofsky >=60%)
Must not have
Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity)
Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 or strong inducers of CYP450. Lists including medications and substances known or with the potential to interact with the specified CYP3A4 isoenzymes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to each cycle and at eot and 1 year post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial tests pacritinib to treat KSHV-associated KICS or MCD in people living with HIV.
Who is the study for?
Adults with KSHV-associated inflammatory cytokine syndrome or multicentric Castleman disease, who have symptoms like fever and fatigue, and lab abnormalities such as anemia. They must not be severely ill from these conditions, have good heart function, agree to use contraception if applicable, and can't be on certain drugs that affect pacritinib.
What is being tested?
The trial is testing the effectiveness of Pacritinib for treating severe inflammation in HIV-positive individuals with either KICS or MCD. Participants will take Pacritinib orally twice daily for up to 24 weeks and attend regular clinic visits for monitoring through physical exams, blood tests, imaging scans, and possibly tissue samples.
What are the potential side effects?
While specific side effects of Pacritinib are not listed here, similar medications may cause issues like nausea, diarrhea, low blood cell counts increasing infection risk; liver problems; heart issues; allergic reactions; bleeding risks; or other organ-related inflammations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but may not be able to do active work.
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I have been diagnosed with KICS or KSHV-MCD by a specialist.
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I have blood test results showing anemia, low platelets, low albumin, or high CRP due to my condition.
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I do not have severe symptoms from KSHV-related conditions.
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My liver and kidney functions are within safe ranges for the trial.
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I am on treatment to control my chronic hepatitis B.
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I have symptoms like fever, fatigue, nausea, or cough related to my condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Kaposi's sarcoma with symptoms, not just in my mouth.
Select...
I am not taking any strong medication that affects liver enzymes.
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I haven't had severe bleeding or bleeding problems in the last year.
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My liver function is moderately or severely impaired.
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I have been diagnosed with primary effusion lymphoma or another type of lymphoma.
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I do not have serious heart conditions like heart failure or unstable angina.
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I do not have any ongoing serious infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to each cycle and at eot and 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to each cycle and at eot and 1 year post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit
Secondary study objectives
Effect of pacritinib on concurrent diagnosis of Kaposi sarcoma (KS)
Safety of pacritinib
Time to treatment failure and duration of benefit
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160370%
Diarrhea
50%
Febrile neutropenia
50%
Dehydration
50%
Anorexia
40%
Mucositis oral
30%
Rash maculo-papular
30%
Nausea
30%
Fatigue
30%
Hypertension
20%
Neutrophil count decreased
20%
Alanine aminotransferase increased
20%
Colitis
20%
Platelet count decreased
20%
Abdominal pain
20%
Skin infection
20%
C Diff
20%
Pain in extremity
10%
Sinusitis
10%
Oral pain
10%
Soft tissue infection
10%
Oral fungus
10%
Creatinine increased
10%
Anemia
10%
Pain of skin
10%
Edema trunk
10%
Rectal pain
10%
Ileus
10%
Vomiting
10%
Aspartate aminotransferase increased
10%
Hyponatremia
10%
CMV+
10%
Electrocardiogram QT corrected interval prolonged
10%
Periorbital edema
10%
Anaphylaxis
10%
Headache -migraine
10%
Abdominal Pain
10%
Metabolism and nutrition disorders - Other
10%
Acute GVHD of skin
10%
Urticaria
10%
Metabolism and Nutrition disorders - Other
10%
Edema limbs
10%
Hypotension
10%
Thromboembolic event
10%
Hypoxia
10%
Insomnia
10%
Anxiety
10%
Hallucinations
10%
Headache
10%
Cardiac disorders - Other
10%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Phase 2: Pacritinib With Sirolimus and Tacrolimus
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Treatment with pacritinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacritinib
2017
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,022 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
613 Total Patients Enrolled