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RECRUITING
NCT03555851

Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2018-07-13

Completion Date

2035-08

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

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.

OTHER

Specimen collection

Buccal swabs will be obtained from donors for pharmacogenomics.

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States