RecruitingNot Applicable

Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

United States120 participantsStarted 2018-07-13

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Informed consent and HIPAA authorization for release of personal health information signed by the subject.
✓. Age ≥ 18 years at the time of consent.
✓. 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.
✓. Recipient only: Planned post-transplant cyclophosphamide
✓. 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

✕. 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.
✕. Recipient only: Treatment with any investigational drug within 30 days prior to day -6 of treatment
✕. 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.

What they're measuring

Comparison of Cy cMax Values

Timeframe: Approx. 24 mos

Trial details

NCT IDNCT03555851

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2033-10

Contact for this trial

Elizabeth Parke

980-442-2011 elizabeth.parke@atriumhealth.org

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