Microbiome Evaluation for Graft-versus-Host Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the vaginal microbiome (the community of bacteria, fungi, and viruses in the body) changes in women undergoing allogeneic HCT, a type of stem cell transplant. The researchers aim to determine if these changes are linked to vulvovaginal graft-versus-host disease, a condition affecting the vagina and vulva. Women planning to undergo this transplant or who have already had it and developed symptoms are suitable candidates for this study. Participants will undergo vaginal exams and symptom assessments before the transplant and at regular intervals afterward. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this observational study is safe?
Research has shown that allogeneic hematopoietic cell transplantation (HCT) has been thoroughly studied for safety. Studies have found that severe liver issues and the most serious forms of liver-related graft-versus-host disease (GVHD) are now much less common. Improved transplant techniques and care have led to this progress. However, some side effects can still occur. About 44% of patients might experience GVHD, but only around 15% of these cases are severe. While risks exist, medical care can manage many side effects. Overall, the treatment is generally well-tolerated, but participants must stay informed and be closely monitored during and after the procedure.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve the diagnosis and understanding of vulvovaginal graft-versus-host disease (GVHD) by evaluating the microbiome of patients undergoing allogeneic hematopoietic cell transplantation (HCT). Unlike standard treatments for GVHD, which focus on managing symptoms with immunosuppressive drugs, this research explores the potential role of the vaginal microbiome in the disease's development and progression. By gaining insights into the microbial environment, researchers hope to uncover new diagnostic markers or therapeutic targets that could lead to more effective, personalized treatment strategies in the future.
What evidence suggests that this study's methods could help understand vulvovaginal GVHD?
Allogeneic hematopoietic cell transplantation (HCT) uses donor stem cells to treat patients with blood-related diseases. Research has shown that it can provide long-term benefits, with about 40% of patients living for many years post-treatment. This method is particularly beneficial for older patients with blood cancers, offering a potential cure. However, challenges include the risk of disease recurrence and infections after the transplant. This study focuses on vulvovaginal graft-versus-host disease (GVHD) in participants undergoing allogeneic HCT, but understanding HCT's effectiveness aids in improving overall patient outcomes.36789
Who Is on the Research Team?
Betty K Hamilton, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Assessment
Participants undergo a vulvovaginal symptom questionnaire and vaginal microbiome evaluation
Post-transplant Follow-up
Participants are monitored for changes in the vaginal microbiome and symptoms of vulvovaginal GVHD at 6 and 12 months post-transplant
Symptom-triggered Assessment
Additional vaginal exams are conducted if symptoms of vulvovaginal GVHD develop
What Are the Treatments Tested in This Trial?
Interventions
- Vaginal Microbiome Evaluation
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
Long-Term Results of Hematopoietic Cell Transplantation ...
Allo-HCT produced 5-year and 10-year OS rates of 37.8% and 30.6%, respectively, while 5-year and 10-year PFS rates were 31.4% and 24.7%, ...
The 2023 EBMT report on hematopoietic cell ...
When compared to the 2022 data, an overall increase of +3.4% was observed (+7.8% allogeneic HCT and +0.4% autologous HCT). In addition, there ...
3.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/7436/528851/Treatment-Trends-and-Outcomes-of-AllogeneicTreatment Trends and Outcomes of Allogeneic ...
50% of transplanted ALL patients are alive with good long-term survival of 40%. Lack of availability of prohibitively expensive novel agents ...
Outcomes of Allogeneic Hematopoietic Stem Cell ...
Allo-HCT offers curative potential for patients aged 70 and above with hematologic malignancies. •. Post-transplant relapse and infection remain the leading ...
Review Allogeneic Hematopoietic Cell Donor Selection
Outcomes of HCT using matched unrelated donors (8/8 allele HLA-matched, MUDs) now result in similar outcomes to recipients of MSD HCT, in part ...
Improved outcomes with allogeneic hematopoietic cell ...
Severe liver dysfunction is now much less common following allogeneic HCT, and grade IV hepatic GVHD has all but disappeared. Based on observations that ...
Improving Safety and Outcomes After Allogeneic ...
This study reports the results of outcomes-directed improvements in transplantation design, GVHD prophylaxis, and supportive care
Better clinical outcomes and lower triggering of ...
Home-based treatment following Allo-HCT yields multiple promising clinical outcomes and improved systemic inflammatory markers, which may contribute to less ...
Outcomes of allogeneic hematopoietic cell transplantation ...
Adverse events related to all-HCT were manageable with rates of acute and chronic graft-versus-host disease in 44.0% (39.6-48.4%; grade III/IV: 15.2%) and 46.5% ...
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