Identifying biomarkers in patients treated with cyclophosphamide after stem cell transplant
Blood Samples to Identify Biomarkers for Post-Transplant Cyclophosphamide
This study is trying to find markers in the blood of patients who have had a stem cell transplant to see how well they respond to the drug cyclophosphamide and if these markers can help predict their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT04160390 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood samples from patients undergoing allogeneic hematopoietic stem cell transplant to investigate how their bodies metabolize cyclophosphamide, a drug used post-transplant. The study aims to identify biomarkers that could predict patient responses to the drug, potentially leading to the development of a blood test for monitoring treatment efficacy. It also evaluates the relationship between metabolomics, pharmacokinetics, and clinical outcomes, including acute graft versus host disease. Additionally, donor samples will be analyzed to assess their impact on recipient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for allogeneic hematopoietic cell transplant with a haploidentical donor who will receive cyclophosphamide post-transplant.
Not a fit: Patients not undergoing allogeneic hematopoietic cell transplant or those not receiving cyclophosphamide will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment plans for patients undergoing stem cell transplants, improving their outcomes with cyclophosphamide.
How similar studies have performed: While the approach of identifying biomarkers in transplant patients is not entirely novel, the specific focus on cyclophosphamide and its metabolites in this context is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled to undergo allogeneic hematopoietic cell transplant (HCT) with a haploidentical donor. * Allogeneic HCT scheduled to treat any underlying disease. Patients with nonmalignant diseases or cancer are eligible * Scheduled to receive post-transplant cyclophosphamide (any dose, any number of doses, any dosing frequency) as part of their post-graft immunosuppression or GVHD prophylaxis. Patients enrolled on treatment protocols that include post transplant cyclophosphamide (PTCy) but do not include mycophenolate mofetil (MMF) or tacrolimus can participate * Willingness to: * Provide blood * Permit medical record review
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeannine S McCune — City of Hope Medical Center
- Study coordinator: Jeannine McCune
- Email: JMCCUNE@coh.org
- Phone: 626-359-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.