Observational Study on Factors Affecting Post-transplant Cyclophosphamide Efficacy

This study is looking at how different factors might affect the success of a treatment called cyclophosphamide (Cy) after a stem cell transplant for leukemia. Researchers want to understand how your genes and your donor's genes (pharmacogenomics), how your body processes the drug (pharmacokinetics), and certain immune cells (T cell phenotypes) influence the treatment. The goal is to find ways to give cyclophosphamide more effectively, reducing side effects like graft-versus-host disease (GVHD) while still fighting the cancer. To do this, they will compare cyclophosphamide levels in your body (Cy cMax Values) about 24 months after transplant. You may be able to join if you are 18 years or older and have leukemia.

Study design
This is an observational study, meaning researchers will collect information without giving a specific treatment. It plans to include 120 participants.
What's involved
Buccal swabs (a cheek swab) will be collected from donors for genetic testing. Blood samples will be taken to measure drug levels before and after transplant.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, comparing Cy cMax Values, is measured approximately 24 months after transplant.

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NCT03555851

Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

Recruiting
Not specifiedAges 18+Observational
Wake Forest University Health Sciences
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:CyclophosphamideSpecimen collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of Cy cMax Values
Measured over Approx. 24 mos
Leukemia, Not Otherwise Specified
Leukemia, Other
1 sites across 1 states
North Carolina1
  • Aleksander Chojecki, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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  • Comparison of Cy cMax ValuesApprox. 24 mos

    Evaluation and comparison of average Day 3 Cy cMax values between subjects who experience acute GVHD versus subjects who do not experience acute GVHD