Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm
Conditions
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.
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.
Interventions
PROCEDUREDental Cleaning
Dental cleaning
PROCEDUREDental Plaque sampling
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of moderate-to-severe chronic graft versus host disease | At 1-year post-transplant |
Secondary
| Measure | 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 |
| Proportion of enrolled patients who receive the intervention (feasibility) | Up to 2 years |
Countries
United States
Contacts
CONTACTArmin Rashidi, MD, PhD
PRINCIPAL_INVESTIGATORArmin Rashidi, MD, PhD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed