NCT06856226 Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
| NCT ID | NCT06856226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2026-03-04 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: After an allogeneic hematopoietic stem cell transplant (HSCT), the donor genome is found in the recipient s circulation and tissues. Post-HSCT recipients may receive a medication in which the dosing needs to be adjusted based on genetic variation. While genes in donor genome may influence dosing and administration of some agents, the majority of established gene-drug pairs in pharmacogenetics are related to expression of metabolic or transporting enzymes located in recipients tissues, often the liver. Determining which genetic variants influence drug disposition in HSCT recipients is complicated by chimerism in samples that are routinely collected for determining genotype. However, chimerism in tissues is poorly studied in this patient population. Objectives: To determine the most reliable host genomic source for pharmacogenetic testing in participants that have received allogeneic HSCT. Eligibility: People ages 18 years and older who are enrolled on a clinical trial at the NIH Clinical Center under which they will donate or receive an allogeneic HSCT. Design: DNA is collected prior to HSCT and for two years after HSCT. Blood will be collected and skin fibroblast cell lines will be established prior to HSCT to serve as a reference genome. Blood, buccal cells, skin, and hair will be monitored for the development of mixed chimerism via detection of short tandem repeats. Liver biopsies will be collected from participants undergoing hepatic surgery. Pharmacoscan arrays will be conducted to determine which samples are useful for pharmacogenetic testing in participants who receive allogeneic HSCT. A probe drug cocktail will be administered pre- and post-HSCT to determine if transplantation alters the metabolic phenotype of liver enzymes. ...
Eligibility 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
Contact & Investigator
Christopher G Kanakry, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06856226 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06856226 currently recruiting?
Yes, NCT06856226 is actively recruiting participants. Contact the research team at amy.vicens@nih.gov for enrollment information.
Where is the NCT06856226 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06856226 clinical trial?
NCT06856226 is sponsored by National Cancer Institute (NCI). The principal investigator is Christopher G Kanakry, M.D. at National Cancer Institute (NCI). The trial plans to enroll 88 participants.
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