Best germline DNA source to guide drug dosing after allogeneic stem cell transplant
Official title: Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Run by National Institutes of Health Clinical Center (CC) · NCT06856226 · Data updated 2026-11-12
This project will test whether blood, skin, or other tissue samples give the most reliable genetic information to guide medicine dosing for adults who receive an allogeneic stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | March 4, 2026 |
| Main results expected | December 1, 2030 |
| Study ends | December 1, 2031 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06856226 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who are enrolled on an NIH Clinical Center clinical trial to donate or receive an allogeneic hematopoietic stem cell transplant and who can provide informed consent, with the donor enrolling alongside the recipient.
✕Probably not a fit
People under 18, patients who had a prior allogeneic HSCT, individuals not enrolled on an NIH Clinical Center trial, or donors who do not enroll with their recipient are not eligible and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
After an allogeneic hematopoietic stem cell transplant, donor-derived DNA can appear in a recipient's blood and tissues, complicating genetic testing for drug dosing. This observational study collects baseline blood and skin fibroblast DNA before transplant and follows participants for up to two years with serial samples of blood, buccal cells, skin, hair, and liver tissue when available. Whole genome sequencing (including specialized pharmacogenetic analysis with Aldy) will be used to compare tissues for chimerism and to identify the most reliable host genomic source for pharmacogenetic testing. Donor and recipient pairs enrolled at the NIH Clinical Center provide matched samples to determine how donor-derived DNA affects genotype interpretation over time.
Why it matters
Potential benefit: If successful, the study could identify which tissue samples give accurate pharmacogenetic results after transplant, helping clinicians pick safer and more effective medication doses for HSCT recipients.
How similar studies have gone: While pharmacogenetic gene-drug relationships are established in non-transplant populations, reliable germline sourcing in allogeneic HSCT recipients is poorly studied, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Age \>=18 years * Participants must be enrolled on a clinical trial at the NIH Clinical Center (CC) under which they will donate or receive an allogeneic HSCT. The participant and their donor must enroll together to provide a complete set of samples for analysis. * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Donors are not allowed to enroll without a recipient * Prior allogeneic HSCT * History of psychiatric disorder which may compromise compliance with protocol requirements. * Pregnant and lactating individuals
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Christopher G Kanakry, M.D. — National Cancer Institute (NCI)
- Study coordinator: Ashley E Carpenter
- Email: carpentera@mail.nih.gov
- Phone: (240) 760-6009
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.