Using light therapy to treat oral Graft-Versus-Host Disease after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of photobiomodulation (PBM) therapy for patients suffering from oral Graft-Versus-Host Disease (GVHD) following stem cell transplantation. Participants will receive either the PBM therapy using the Thor LX2.3 system or a placebo sham device. Eligible patients are those who have experienced oral cGVHD and have not responded to at least one prior treatment. The study aims to provide a new therapeutic option for this challenging condition.

Why it matters

Who can join: the full rules

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 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 ≥2 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.

Where it's running

• National Institute of Health (Data Collection AND Specimen Analysis)
  Bethesda, Maryland, United States Recruiting
• Memorial Sloan Kettering at Basking Ridge (Consent only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent only)
  Harrison, New York, United States Recruiting

Study contacts

• Principal investigator: Alina Markova, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Alina Markova, MD
• Email: markovaa@mskcc.org
• Phone: 6466082342

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Ruxolitinib to prevent complications after haploidentical stem cell transplants

  This study is testing if the drug Ruxolitinib can help prevent complications like graft-versus-host disease in patients receiving stem cell transplants from partially matched donors.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT06008808

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• Ruxolitinib for Graft-Versus-Host Disease in Clinical Practice

  This study tests how well Jakavi (ruxolitinib) works and how safe it is for people with acute or chronic GVHD being treated in real-world medical settings.

  Recruiting Novartis · Tokyo · NCT07594587

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• How iNKT immune cells after allogeneic stem cell transplant relate to transplant complications

  This study tests whether levels of invariant NKT cells in the blood after an allogeneic stem cell transplant can be linked to complications like GvHD, infections, or relapse in patients with AML.

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• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.