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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ Recipients and donors must meet all of the following applicable inclusion criteria to participate in this study:

• 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

Locations
United States
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
Contact Information
Primary
Elizabeth Youngblade
elizabeth.youngblade@atriumhealth.org
980-442-2011
Time Frame
Start Date: 2018-07-13
Estimated Completion Date: 2035-08
Participants
Target number of participants: 120
Treatments
Recipient
Cyclophosphamide
Donor
Specimen collection
Sponsors
Collaborators: Atrium Health Levine Cancer Institute
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov