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Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

NCT06856226 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2026-03-09

No results posted yet for this study

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.

...

Conditions

Interventions

OTHER

Arm 1

Short tandem repeat (STR) analysis from genomic DNA extracted from biospecimens.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christopher G Kanakry, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2027-12-01
Completion
2028-12-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856226 on ClinicalTrials.gov