Examining factors that affect the effectiveness of post-transplant cyclophosphamide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how donor and recipient pharmacogenetics, drug pharmacokinetics, and T cell phenotypes influence the efficacy of post-transplant cyclophosphamide (PTCy) in patients undergoing hematopoietic stem cell transplants. The primary goal is to identify associations between genetic factors and the incidence and severity of acute and chronic graft versus host disease (GVHD). Additionally, the study will measure cyclophosphamide exposure and its correlation with GVHD and adverse events. Initially, 20 participants will be enrolled, followed by an additional 100 subjects to enhance the study's findings.

Why it matters

Who can join: the full rules

Inclusion Criteria

Recipients and donors must meet all of the following applicable inclusion criteria to participate in this study:

1. Informed consent and HIPAA authorization for release of personal health information signed by the subject.
2. Age ≥ 18 years at the time of consent.
3. Subject is scheduled as a recipient or respective donor (Donor consent/participation is not required for subjects undergoing matched unrelated donor HCT) for the following hematopoietic stem cell transplants (HCT) procedures using a non-myeloablative regimen at Levine Cancer Institute (LCI), and has been deemed a qualified candidate by his/her physician, per LCI medical standards: haplo-identical donor HCT, match related donor (MRD) HCT, matched unrelated donor (MUD) HCT.
4. Recipient only: Planned post-transplant cyclophosphamide
5. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

Subjects meeting any of the criteria below may not participate in the study:

1. Recipient only (applies only to haplo-identical and MRD HCT recipients; not required for MUD HCT recipients): Does not have a respective donor who is willing to sign informed consent for participation in this study.
2. Recipient only: Treatment with any investigational drug within 30 days prior to day -6 of treatment
3. Donor only (applies only to haplo-identical and MRD HCTs; donor participation is not required for MUD HCTs): Does not have a respective recipient who is willing to sign informed consent for participation in this study.

Where it's running

• Levine Cancer Institute
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Aleksander Chojecki, MD — Wake Forest University Health Sciences
• Study coordinator: Elizabeth Parke
• Email: elizabeth.parke@atriumhealth.org
• Phone: 980-442-2011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.