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Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

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ClinicalTrials.gov Identifier: NCT03954236
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
Hackensack Meridian Health
Incyte Corporation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.

Condition or disease Intervention/treatment Phase
Non-sclerotic Cutaneous Chronic Graft-versus-host Disease Drug: topical ruxolitinib 1.5% cream Other: Topical vehicle/moisturizer cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized double-blinded, vehicle- and comparator controlled pilot study followed by an open label extension for all patients who wish to continue on study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot, Prospective, Randomized, Double-Blinded, Vehicle- and Comparator-Controlled Trial on Safety and Efficacy of a Topical Inhibitor of Janus Kinase 1/2 (Ruxolitinib INCB018424 Phosphate 1.5% Cream) for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: topical ruxolitinib BID to left side of face/body
And topical moisturizer BID to right side of face/body.
Drug: topical ruxolitinib 1.5% cream
Patients will be prescribed twice daily use of topical ruxolitinib 1.5% cream (randomized half of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days. Topical ruxolitinib will be provided as topical cream. At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.

Other: Topical vehicle/moisturizer cream
Patients will be prescribed twice daily use of vehicle/moisturizer (for contralateral side of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days.At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.

Experimental: topical ruxolitinib BID to right side of face/body
And topical moisturizer BID to left side of face/body.
Drug: topical ruxolitinib 1.5% cream
Patients will be prescribed twice daily use of topical ruxolitinib 1.5% cream (randomized half of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days. Topical ruxolitinib will be provided as topical cream. At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.

Other: Topical vehicle/moisturizer cream
Patients will be prescribed twice daily use of vehicle/moisturizer (for contralateral side of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days.At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.




Primary Outcome Measures :
  1. the difference in body surface area (BSA) of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion [ Time Frame: 28 days (+/-3 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (≥ 12 years)
  • History of allogeneic hematopoietic stem cell transplantation
  • BSA of at least 2% of clinically or histologically confirmed non-sclerotic cutaneous chronic graft-versus-host disease (diagnosed and BSA calculated in accordance with the National Institutes of Health Chronic Graft-versus-Host Disease Consensus for Clinical Trials: I. The 2014 Diagnosis and Staging Working Group Report)
  • Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and <18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
  • Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
  • If on systemic therapy for GVHD, systemic therapy must be stable for past 4 weeks; however, any planned systemic corticosteroid taper during the study will be permitted.Changes in systemic therapy during the study period will be allowed for the management of non-skin GVHD.
  • Fluent in English for purposes of completing the study questionnaires since they are validated in English.
  • Any concurrent topical therapies including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy must be discontinued on Study Day 0.

Exclusion Criteria:

  • Known history of allergy to any ingredient of the study medication
  • Patients with sclerotic cutaneous graft-versus-host disease including deep sclerotic, lichen sclerosus-like, morphea-like subtypes of chronic cutaneous GVHD
  • Use of concurrent topical therapy including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy after Study Day 0 up to and including Study Day 28.
  • Changes in systemic therapy during study period for the purpose of treating skin GVHD.
  • Special populations:

    • vulnerable populations e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners
    • patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
  • Concurrent participation in another topical trial of a drug(s) or medical device, or the subject is in an exclusion period after a previous trial of drug(s) or medical device
  • Pregnancy or lactation
  • Patients with inadequate liver function (ALT above 4 × upper limit of normal [ULN] for the patient's age or direct bilirubin 4 × ULN for the patient's age and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD
  • Active uncontrolled infection requiring systemic therapy. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954236


Contacts
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Contact: Alina Markova, MD 646-888-6010 markovaa@mskcc.org
Contact: Doris Ponce, MD 212-639-4838

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alina Markova, MD    646-888-6010      
Contact: Doris Ponce, MD    212-639-4838      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Hackensack Meridian Health
Incyte Corporation
Investigators
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Principal Investigator: Alina Markova, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03954236     History of Changes
Other Study ID Numbers: 18-412
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Ruxolitinib Cream
18-412

Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases