RecruitingNCT03555851

Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

Elucidation of Factors Predicting Efficacy and Toxicity of Post Transplantation Cyclophosphamide (PTCy) as a Strategy for Graft Versus Host Disease Prevention in Haploidentical, Matched Related Donor and Matched Unrelated Donor Peripheral Blood Hematopoietic Cell Transplantation


Sponsor

Wake Forest University Health Sciences

Enrollment

120 participants

Start Date

Jul 13, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

This study will examine the influence of donor and recipient pharmacogenetics (PG), drug pharmacokinetics (PK), and T cell phenotypes and how it may permit a tailored dosing strategy to improve the therapeutic index of post-transplant cyclophosphamide (PTCy) and optimize the graft versus tumor effect, while minimizing acute and chronic graft versus host disease (GVHD).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines why a certain chemotherapy drug given after a stem cell transplant (called post-transplant cyclophosphamide) works better in some patients than others, by collecting blood and tissue samples from transplant patients and their donors. **You may be eligible if...** - You are 18 years or older - You are scheduled to receive a stem cell (bone marrow) transplant at Levine Cancer Institute using a reduced-intensity (non-myeloablative) approach - You are eligible for a transplant from a half-matched family member (haploidentical), a fully matched family member, or an unrelated matched donor - You are planned to receive post-transplant cyclophosphamide as part of your care **You may NOT be eligible if...** - You do not meet the transplant eligibility criteria set by your doctor - You are not scheduled for one of the specific transplant types listed in the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Pharmacogenomics of candidate genes and pharmacokinetic analyses of cyclophosphamide administered as part of a reduced intensity conditioning (RIC) regimen and as post-transplant GVHD prophylaxis will be examined.

OTHERSpecimen collection

Buccal swabs will be obtained from donors for pharmacogenomics.


Locations(1)

Levine Cancer Institute

Charlotte, North Carolina, United States

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NCT03555851


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