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Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

NCT03555851 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-01-08

No results posted yet for this study

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).

Conditions

  • Leukemia, Not Otherwise Specified
  • Leukemia, Other

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.

Sponsors & Collaborators

  • Atrium Health Levine Cancer Institute

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Aleksander Chojecki, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2033-10-31
Completion
2035-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555851 on ClinicalTrials.gov