Chronic Graft Versus Host DiseaseNCT07535008
Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
A study testing Dental Cleaning and Dental Plaque sampling in people with Chronic Graft Versus Host Disease and Acute Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Dental Cleaning and Dental Plaque sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to 30 Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Armin Rashidi, MD, PhD, 206-667-2506, arashidi@fredhutch.org
Armin Rashidi, MD, PhD
About this study
This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.
Read the detailed description
OUTLINE:
Patients who have not undergone dental cleaning within 3 months preceding the baseline visit undergo dental cleaning at baseline (before the initiation of transplant conditioning) according to standard of care. All patients undergo simplified dental cleaning on day +28 following HCT.
After completion of study intervention, patients are followed up on days +84 and +180 and at 1 year.
- Conditions
- Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
- Being tested
- Dental Cleaning, Dental Plaque sampling
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental CleaningProcedure or surgery
Dental cleaning
Dental Plaque samplingProcedure or surgery
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (dental cleaning) | Experimental | Patients undergo simplified dental cleaning on day +28 following HCT. Receives: Procedure: Dental Cleaning; Procedure: Dental Plaque sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of moderate-to-severe chronic graft versus host disease
Measured: At 1-year post-transplant
Secondary outcomes (3)
Probability of grade III-IV acute graft versus host disease
Measured: At 6-months post-transplant
Proportion of eligible patients approached who consent (feasibility)
Measured: Up to 2 years
Proportion of enrolled patients who receive the intervention (feasibility)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start12 May 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, MD, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535008
- Sponsor's protocol ID
- RG1126351
- Other IDs
- NCI-2026-02262, 21222
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No