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A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

RecruitingPhase 2Ages 4 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Allo-HCT recipients * Age โ‰ฅ 4 years-old * Oral cGvHD with NIH-modified OMRS score โ‰ฅ 3 who have failed โ‰ฅ 1 line of therapy, including topical corticosteroids.. * No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment. * If a patient is currently using another oral topical treatment for mouth lesions/symptoms, patient must be stable on this treatment for โ‰ฅ2 weeks prior to study enrollment. Patient may continue same topical dose/frequency during the study period. Exclusion Criteria: * Presence of an active uncontrolled infection. Subjects with a controlled infection receiving 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 with the treatment protocol including appropriate supportive care, follow-up, and research tests. * Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
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What it tests

  • Photobiomodulation Therapy
  • Placebo sham device
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Where

9 sites
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, United States
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, United States
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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