Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Probability of moderate-to-severe chronic graft versus host disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Prevention (dental cleaning)
Patients undergo simplified dental cleaning on day +28 following HCT.
干预措施: Dental Cleaning (Procedure)
Prevention (dental cleaning)
Patients undergo simplified dental cleaning on day +28 following HCT.
干预措施: Dental Plaque sampling (Procedure)
结局指标
主要结局
Probability of moderate-to-severe chronic graft versus host disease
时间窗: At 1-year post-transplant
次要结局
- 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)