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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how our genes affect how medications are processed in patients who receive a special treatment called allogeneic hematopoietic stem cell transplant (HSCT). After this transplant, patients have both their own genes and those from the donor, which can make it tricky to know how to adjust medication doses correctly. The goal of the trial is to find out the best way to test for genetic differences that influence how drugs are metabolized, which means how the body breaks down and uses medications.

To be eligible for this trial, participants must be at least 18 years old and enrolled in a clinical trial at the NIH Clinical Center, where they will either receive or donate stem cells. Both the patient and their donor need to participate to provide complete samples for testing. During the study, participants can expect to have blood and other samples collected before and for two years after their transplant. This will help researchers understand how the transplant affects their body’s ability to process medications. It’s important to note that donors can only enroll if they are paired with a recipient, and individuals who have had a prior transplant or are pregnant cannot participate.

Gender

ALL

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