Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-02262 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21222 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (dental cleaning) | Experimental | Patients undergo simplified dental cleaning on day +28 following HCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Cleaning | Procedure | Dental cleaning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of moderate-to-severe chronic graft versus host disease | At 1-year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armin Rashidi, MD, PhD | Contact | 206-667-2506 | arashidi@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Armin Rashidi, MD, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dental Plaque sampling |
| Procedure |
Ancillary studies |
|
| Proportion of enrolled patients who receive the intervention (feasibility) |
| Up to 2 years |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |