Phase
Condition
Transplant Rejection
Treatment
Placebo sham device
Photobiomodulation Therapy
Clinical Study ID
Ages > 4 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Allo-HCT recipients
Age ≥ 4 years-old
Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy,including topical corticosteroids..
No change in systemic immunosuppressive therapy (type or intensity level) within 2weeks prior to enrollment.
If a patient is currently using another oral topical treatment for mouthlesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior tostudy enrollment. Patient may continue same topical dose/frequency during the studyperiod.
Exclusion
Exclusion Criteria:
Presence of an active uncontrolled infection. Subjects with a controlled infectionreceiving definitive therapy for 48 hours prior to enrollment are eligible.
Personal history of mucosal head and neck cancer in the past 5 years.
Pregnant or breastfeeding.
The subject or guardian is unable to give informed consent or unable to comply withthe treatment protocol including appropriate supportive care, follow-up, andresearch tests.
Any serious medical or psychiatric illness that could, in the Investigator'sopinion, potentially interfere with the completion of treatment according to thisprotocol.
Study Design
Connect with a study center
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland 20892
United StatesActive - Recruiting
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York 11553
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Consent only)
West Harrison, New York 10604
United StatesSite Not Available
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburg, Pennsylvania 15213
United StatesSite Not Available
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting


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