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JAK2/IRAK1/CSF1R Inhibitor
Pacritinib for Chronic Graft-versus-Host Disease
Phase 1 & 2
Recruiting
Led By Noa G Holtzman, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months through up to 12 months of treatment
Awards & highlights
Study Summary
This trial is testing a drug (pacritinib) for people with moderate or severe chronic graft-versus-host disease that has not responded to previous treatment.
Who is the study for?
Adults over 18 with moderate or severe chronic graft-versus-host disease (cGVHD) after stem cell transplant, which hasn't improved after at least two treatments. They must be in remission from their primary cancer for three months and have good organ function. Participants should not have acute GVHD, active infections like HIV or hepatitis, recent use of certain drugs, other cancers needing treatment, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial is testing Pacritinib's effectiveness on patients with cGVHD who haven't responded to previous therapies. It involves taking the drug daily at home and attending regular clinic visits for tests and questionnaires about quality of life. The study may last up to a year with follow-up visits extending another year.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored closely for any adverse reactions due to Pacritinib throughout the trial period during their regular clinic visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months through up to 12 months of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months through up to 12 months of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Safety of pacritinib in refractory cGVHD.
Phase II: Overall response rate (ORR)
Secondary outcome measures
Phase 2: Clinical outcomes
Phase 2: Safety
Phase I: Pharmacokinetics (PK)
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160345%
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
9%
Anorexia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Hypotension
9%
Cellulitis
5%
Tremors
5%
Fever
5%
Multi-organ failure
5%
Lung infection
5%
C Diff
5%
Infusion related reaction
5%
Erythroderma -acute GVHD
5%
Folicular rash
5%
Rash over body
5%
Delirium
5%
Encephalitis - HHV6
5%
Encephalopathy
5%
Lung infection -Pneumonia
5%
Sepsis
5%
Mulit-organ failure
5%
Suspected VOD
5%
Abdominal distension
5%
Respiratory Failure
5%
Urinary tract pain
5%
Nausea
5%
Myocardial infarction
5%
Fall
5%
CPK increased
5%
Skin sloughing off
5%
Chills
5%
Tachycardia
5%
Fracture
5%
Electrocardiogram QT corrected interval prolonged
5%
Catheter related infection
5%
Bilirubin increase
5%
Dry mouth
5%
Creatinine increased
5%
White blood cell count decreased
5%
Abdominal Pain
5%
Sinusitis
5%
LDH Increased
5%
Alanine aminotransferase increased - VOD
5%
Alanine aminotransferase increased - suspected VOD
5%
Hypokalemia
5%
Erythroderma
5%
Diffuse rash on face, trunk, and extremities; eyelids swelling
5%
Pulmonary edema
5%
Dyspnea
5%
Hyponatremia
5%
Hypophosphatemia
5%
Meningitis
5%
Respiratory failure
5%
Insomnia
5%
Epistaxis
5%
Lethargy
5%
Gastrointestinal Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Trial Design
3Treatment groups
Experimental Treatment
Group I: Escalating doses of treatmentExperimental Treatment1 Intervention
Escalating doses of pacritinib to confirm safety in cGVHD
Group II: Arm 3 - High-doseExperimental Treatment1 Intervention
Expansion dosing to evaluate the efficacy of pacritinib 200 mg PO BID
Group III: Arm 2 - Low-doseExperimental Treatment1 Intervention
Expansion dosing to evaluate the efficacy of pacritinib 100 mg PO BID
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
13,662 Previous Clinical Trials
40,926,023 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Noa G Holtzman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,753 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart conditions like heart failure or irregular heartbeats.I have moderate or severe chronic GVHD after a stem cell transplant.I agree to use effective birth control during and 30 days after the study.I have active acute GVHD without signs of chronic GVHD.I am on a stable or decreasing dose of medication for cGVHD.I do not have any ongoing serious infections.I can care for myself but may need occasional help.My lung function is significantly reduced, with an FEV1 <= 39%.I haven't taken ruxolitinib or ibrutinib in the last 14 days.I have stopped using strong CYP3A4 drugs 2 weeks before starting the study drug.My chronic GVHD hasn't improved after 2 or more treatments.I am 18 years old or older.I am unwilling to accept blood transfusions.I have an active HIV, Hepatitis B, or Hepatitis C infection.I haven't had severe bleeding or bleeding problems in the last year.I have no active cancer treatment except for non-serious skin, cervical, or breast conditions.My original cancer has been stable and in remission for 3 months before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 - High-dose
- Group 2: Escalating doses of treatment
- Group 3: Arm 2 - Low-dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities remaining to join this experiment?
"Per the clinicaltrials.gov catalogue, this trial is not presently taking on any more participants. Initially posted in December 6th 2022 but last updated November 30th 2022, it has already achieved its recruitment goal; however there are 169 other trials actively recruiting at present."
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