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Compares treatment options for Graft vs Host Disease
Official title 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)
ClinicalTrials.gov ID: NCT05531786
What this study is testing
What is Pacritinib?
Pacritinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for graft vs host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Chronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 1. Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria
- cGVHD that did not respond to \>=2 lines of prior systemic therapy. Disease that has failed prior systemic therapy will be defined as follows: a) For...
- Karnofsky performance score \>=60%
- Age \>=18 years.
- If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering dose in the preceding 4 weeks.
You likely can't join if
- Acute GVHD that is active as defined by exhibiting current signs or symptoms of disease without any chronic GVHD (classic and late-acute GVHD per NIH...
- Treatment with ruxolitinib within 24 hours, or ibrutinib within the \<=14 days prior to treatment initiation.
- Active HIV-1 (detectable HIV viral load), or Hepatitis B (HBV) and/or Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of...
- Participants with the following cardiac conditions at screening:
- symptomatic congestive heart failure
- unstable angina pectoris
See the full eligibility criteria
- 1. Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria
- cGVHD that did not respond to \>=2 lines of prior systemic therapy. Disease that has failed prior systemic therapy will be defined as follows: a) For prior corticosteroid-containing regimens, disease that: i) recurs...
- Karnofsky performance score \>=60%
- Age \>=18 years.
- If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering dose in the preceding 4 weeks.
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count \>=1,000/mcL
- platelets \>=50,000/mcL
- total bilirubin \<=1.5 X institutional upper limit of normal OR \<=3 X institutional upper limit of normal in participants with Gilbert's syndrome
- AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal
- eGFR \>= 35 mL/min per CKD-EPI 2021
- Primary malignancy for which the participant received transplant has been in complete clinical remission and stable for 3 months prior to enrollment on study.
- 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...
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Acute GVHD that is active as defined by exhibiting current signs or symptoms of disease without any chronic GVHD (classic and late-acute GVHD per NIH consensus criteria); participants with a clinical presentation...
- Treatment with ruxolitinib within 24 hours, or ibrutinib within the \<=14 days prior to treatment initiation.
- Active HIV-1 (detectable HIV viral load), or Hepatitis B (HBV) and/or Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody).
- Participants with the following cardiac conditions at screening:
- 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).
- Left ventricular ejection fraction \<= 50% by transthoracic echocardiogram (TTE) at screening.
- 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.
- Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.
- Concurrent treatment with any other investigational agents.
- Concurrent use of strong CYP3A4 inducers or inhibitors, must stop 2 weeks prior study drug initiation.
- Known hypersensitivity to JAK inhibitors.
- Participants who are unwilling to accept blood transfusions.
- Pregnancy or breastfeeding.
- Participants with any active, uncontrolled viral, bacterial, or fungal infection are excluded.
- Other malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix or breast which requires active treatment.
- Uncontrolled intercurrent illness evaluated by history, physical exam and chemistries or situation that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.