Post-transplant dental cleaning to prevent chronic graft-versus-host disease

Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fred Hutchinson Cancer Center (other)
• Drugs / interventions: ruxolitinib, cyclophosphamide
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT07535008 on ClinicalTrials.gov

What this trial studies

Adults undergoing T-replete allogeneic hematopoietic cell transplant will receive a baseline dental cleaning if they have not had one within three months, and all participants will undergo a simplified dental cleaning on day +28 after transplant with dental plaque sampling. The study collects plaque samples and monitors participants for signs of chronic GVHD at days +84, +180, and at one year, including an in-person oral medicine visit at Fred Hutch. Key exclusions include edentulous patients, bone marrow graft source, and use of post-transplant cyclophosphamide, ruxolitinib, or anti-thymocyte globulin in conditioning. The approach tests whether altering early post-transplant oral bacterial burden by an additional cleaning affects later chronic GVHD risk.

Who should consider this trial

Good fit: Adults (≥18 years) receiving a T-replete allogeneic hematopoietic cell transplant from a 9/10 or 10/10 matched unrelated donor or cord blood who have natural teeth and can attend in-person follow-up at Fred Hutch are the ideal candidates.

Not a fit: Patients without teeth (edentulous), those receiving bone marrow grafts, or those treated with post-transplant cyclophosphamide, ruxolitinib, or ATG are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding an early post-transplant dental cleaning could lower the risk of chronic GVHD and improve long-term oral health and quality of life after allogeneic HCT.

How similar studies have performed: Preliminary research indicates the post-transplant oral microbiome may influence chronic GVHD, but using a specific post-transplant dental cleaning as a preventive measure is a relatively novel and unproven approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old
* T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed
* One of the following HCT donor types:

  * 9/10 or 10/10 human leukocyte antigen (HLA)-matched unrelated donor
  * Cord blood
* Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)
* Ability to understand and sign a written informed consent document (or legal representative)

Exclusion Criteria:

* Edentulous state
* Bone marrow as graft source
* Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis
* Use of anti-thymocyte globulin (ATG) in conditioning

Where this trial is running

Seattle, Washington

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Armin Rashidi, MD, PhD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Armin Rashidi, MD, PhD

Conditions: Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm