Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

NCT07535008 | Not Yet Recruiting

• 3 other identifiers: RG1126351NCI-2026-0226221222
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Graft Versus Host Disease; Acute Graft Versus Host Disease; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Probability of moderate-to-severe chronic graft versus host disease

  At 1-year post-transplant

Secondary Outcomes (3)

• Probability of grade III-IV acute graft versus host disease

  At 6-months post-transplant

• Proportion of eligible patients approached who consent (feasibility)

  Up to 2 years

• Proportion of enrolled patients who receive the intervention (feasibility)

  Up to 2 years

Study Arms (1)

Prevention (dental cleaning)

EXPERIMENTAL

Patients undergo simplified dental cleaning on day +28 following HCT.

Procedure: Dental Cleaning; Procedure: Dental Plaque sampling

Interventions

Dental Cleaning PROCEDURE

Dental cleaning

Prevention (dental cleaning)

Dental Plaque sampling PROCEDURE

Ancillary studies

Prevention (dental cleaning)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• /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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Armin Rashidi, MD, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin Rashidi, MD, PhD

CONTACT

206-667-2506; arashidi@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)