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Tyrosine Kinase Inhibitor

Pacritinib for Castleman Disease and Syndrome

Phase 2

Waitlist Available

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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to each cycle and at eot and 1 year post treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to each cycle and at eot and 1 year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit

Secondary outcome measures

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 • NCT02891603

45%

Febrile neutropenia

41%

Mucositis oral

36%

Platelet count decreased

23%

Diarrhea

23%

Neutrophil count decreased

23%

Rash maculo-papular

18%

Anemia

18%

Hypertension

18%

Fatigue

14%

Headache

14%

Acute kidney injury

14%

Dehydration

Alanine aminotransferase increased

Anorexia

Aspartate aminotransferase increased

Hypotension

Cellulitis

Diffuse rash on face, trunk, and extremities; eyelids swelling

Dyspnea

Respiratory failure

Lung infection

C Diff

Fracture

Multi-organ failure

Infusion related reaction

Folicular rash

Tremors

Delirium

Fever

Erythroderma -acute GVHD

Sinusitis

Rash over body

Lung infection -Pneumonia

Sepsis

Suspected VOD

Abdominal distension

Respiratory Failure

Urinary tract pain

Fall

CPK increased

Skin sloughing off

Chills

Encephalopathy

Myocardial infarction

Mulit-organ failure

Nausea

Tachycardia

Encephalitis - HHV6

Electrocardiogram QT corrected interval prolonged

Catheter related infection

Bilirubin increase

Dry mouth

Creatinine increased

White blood cell count decreased

Abdominal Pain

LDH Increased

Alanine aminotransferase increased - VOD

Alanine aminotransferase increased - suspected VOD

Hypokalemia

Erythroderma

Pulmonary edema

Hyponatremia

Hypophosphatemia

Meningitis

Insomnia

Epistaxis

Lethargy

Gastrointestinal Disorders - Other

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2: Pacritinib With Sirolimus and Tacrolimus

Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus

Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,306 Total Patients Enrolled

10 Trials studying Castleman Disease

1,829 Patients Enrolled for Castleman Disease

Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)

6 Previous Clinical Trials

488 Total Patients Enrolled

1 Trials studying Castleman Disease

40 Patients Enrolled for Castleman Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this clinical trial available?

"This medical trial is seeking approximately 65 individuals with kaposi's sarcoma-associated herpesvirus inflammatory cytokine syndrome who are aged between 18 and 120."

Answered by AI

Does the research study accommodate minors?

"Individuals aged 18 to 120 are eligible for this clinical trial, with 531 studies available specifically for minors and 1,414 trials focusing on those older than 65."

Answered by AI

What safety measures have been taken to ensure Arm 1 is secure for participants?

"Our internal evaluation of Arm 1's safety ranks it a 2, as there is existing data to suggest that the intervention is safe but no evidence yet regarding effectiveness."

Answered by AI

Are participants currently able to enroll in this experiment?

"Clinicaltrials.gov states that this particular study is no longer recruiting, as the last update was made on September 22nd 2023. Despite this, there are a wealth of other trials currently enrolling patients - 1,942 to be exact!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052618.

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