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Phase I/II Study of Pacritinib for Refractory Chronic Graft-Versus-Host Disease

This study is testing a drug called pacritinib for people with chronic graft-versus-host disease (cGVHD) that hasn't improved with other treatments. cGVHD is an immune system disorder that can happen after a stem cell transplant. We are looking for 50 adults, aged 18 to 120, who have moderate or severe cGVHD and have already tried at least two other treatments without success. The study aims to first check the safety of pacritinib over 28 days (Phase I), and then to see how well it helps improve cGVHD symptoms over 6 months (Phase II). The current status of this study is unclear.

Study design
This is a Phase I/II interventional study, meaning participants will receive the study drug. It plans to enroll 50 participants.
What's involved
You will take pacritinib tablets twice daily for 28-day cycles. You will have blood and urine tests, heart and lung function tests, and possibly a CT scan or other specialized tests.
Compensation
Not stated in the trial record.
Follow-up
The study measures safety at 28 days and overall response rate at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05531786

Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~50 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Pacritinib

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Safety of pacritinib in refractory cGVHD.
Measured over 28 days
+1 more outcome measured

Conditions

Graft vs Host Disease

Explore related trials

Chronic Graft Versus Host Disease

NCT05531786

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

  • University of Miami

    Miami, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Najla El Jurdi, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Rania S Hishmeh, R.N.
[email protected]
(240) 858-3681
Email the study team

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Eligibility criteria

Inclusion

absolute neutrophil count \>=1,000/mcL
platelets \>=50,000/mcL
total bilirubin \<=1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal
eGFR \>= 35 mL/min per CKD-EPI 2021 7. Primary malignancy for which the participant received transplant has been in complete clinical remission and stable for 3 months prior to enrollment on study. 8. Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant who are sexually active must agree to use one (1) highly effective (e.g., intrauterine system containing levonorgestrel intrauterine devices, surgical) or two (2) effective forms of contraception (e.g., barrier method) at study entry, for the duration of study treatment, and for at least 30 days after last study drug exposure. 9. Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion

symptomatic congestive heart failure
unstable angina pectoris
uncontrolled cardiac dysrhythmias
QTc(F) prolongation \>450 ms or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome). 5. Left ventricular ejection fraction \<= 50% by transthoracic echocardiogram (TTE) at screening. 6. Participants with poor pulmonary function as defined by a forced expiratory volume in the first second (FEV1) \<= 39% calculated using the USA-ITS-NIH equation. 7. Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment. 8. Concurrent treatment with any other investigational agents. 9. Concurrent use of strong CYP3A4 inducers or inhibitors, must stop 2 weeks prior study drug initiation. 10. Known hypersensitivity to JAK inhibitors. 11. Participants who are unwilling to accept blood transfusions. 12. Pregnancy or breastfeeding. 13. Participants with any active, uncontrolled viral, bacterial, or fungal infection are excluded. 14. Other malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix or breast which requires active treatment. 15. Uncontrolled intercurrent illness evaluated by history, physical exam and chemistries or situation that would limit compliance with study requirements.

What this trial measures

  • Phase I: Safety of pacritinib in refractory cGVHD.28 days

    grades and types of toxicity reported at each dose level. The overall estimate of the fraction of patients who have a DLT at the MTD will be reported.

  • Phase II: Overall response rate (ORR)6 months

    the fraction with clinical responses reported separately by arm, with a separate 95% confidence interval for each cohort.