Status:
TERMINATED
Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Graft Versus Host Disease
JNS Kinase
Eligibility:
All Genders
12-100 years
Phase:
PHASE2
Brief Summary
Background: About half the people who have a hematopoietic stem cell transplant using donor cells get Chronic Graft Versus Host Disease (cGVHD). This is chronic graft versus host disease. Immune cell...
Detailed Description
Background: * Chronic graft-versus-host disease (cGVHD) develops in approximately half of individuals who undergo allogeneic hematopoietic cell transplant (HCT) and is the leading cause of non-relaps...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have histologically confirmed epidermal Chronic Graft Versus Host Disease (cGVHD) including lichen planus-like, papulosquamous, and erythematous cGVHD with clinical involvement at 2 separate body regions (e.g. right forearm and left forearm).
- Patients must have measurable disease, defined as at least 2 areas of cutaneous, nonulcerated, epidermal cGVHD involvement. Each site must involve at least 0.5% body surface area (1 palm equivalent) and cannot be a site of current or previous nonmelanoma skin cancer (NMSC).
- Stable immunosuppressant or immunomodulatory systemic cGVHD treatment, including phototherapy and extracorporeal photopheresis, for 4 weeks prior to enrollment.
- Age greater than or equal to 12 years. There is no available safety or adverse events data available for children younger than 12 years of age.
- Karnofsky or Lansky greater than or equal to 60
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count greater than or equal to 1,000/mcL
- platelets greater than or equal to 50,000/mcL
- hemoglobin \> 9 g/dL
- total bilirubin \<1.5X institutional upper limit of normal except if known history of Gilbert's disease
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) less than or equal to 5X institutional upper limit of normal
- creatinine clearance greater than or equal to 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
- Willingness to comply with twice daily application of 2 different creams to 2 separate, prespecified sites.
- The effects of ruxolitinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- EXCLUSION CRITERIA:
- Patients concurrently receiving a Janus kinase (JAK) inhibitor (topical or systemic).
- Patients receiving any other investigational agents.
- Patients concurrently taking oral fluconazole.
- Patients concurrently taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including Epstein-Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because ruxolitinib is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study.
- Recurrent or progressive malignancy requiring anticancer treatment.
- Other cancer (except that for which hematopoietic cell transplantation (HCT) was performed) within 2 years of study entry, except nonmelanoma skin cancer or carcinoma in situ of the breast, uterus, or cervix.
- History of cutaneous malignancy at target lesion site.
- Any participant who, in the investigator's opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk.
Exclusion
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03395340
Start Date
November 19 2018
End Date
January 31 2019
Last Update
July 12 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892