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Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an extra dental cleaning soon after a donor stem cell transplant is practical and helps prevent chronic graft-versus-host disease (GVHD). GVHD happens when donated cells attack the patient's healthy tissue. The study is for adults getting certain types of donor stem cell transplants.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Getting a donor stem cell transplant with T cells, a type of immune cell, left in the donated cells.
  • The donor must be unrelated and match 9 out of 10 or 10 out of 10 HLA markers used to match donors, or the transplant must use umbilical cord blood.
  • A past transplant is allowed. Any treatment plan to prepare for the transplant is allowed.
  • Willing to return to Fred Hutch in person for a 1-year follow-up visit, including a mouth health visit.
  • Able to understand and sign a consent form, or have a legal representative do so.

Who can't join

  • Have no natural teeth.
  • Getting a transplant that uses bone marrow as the source of donated cells.
  • Getting cyclophosphamide after transplant or ruxolitinib to prevent GVHD.
  • Getting anti-thymocyte globulin (ATG), a drug that lowers immune cell activity, as part of treatment to prepare for transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

WA