Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:July 13, 2018
End Date:October 2020
Contact:Pearlie Kelly
Email:Pearlie.Kelly@atriumhealth.org
Phone:980-442-2017

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

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).

The primary objective of this single-arm, pilot study is to determine whether
pharmacogenetics (PG) of Cy-related candidate genes from the recipients and/or donors
germ-line DNA is associated with incidence and severity of acute and chronic GVHD. Secondary
objectives include determining whether pharmacogenetics (PG) of Cy-related candidate genes
from the recipients and/or donors germ-line DNA is associated with Cy (and metabolites)
exposure and toxicities; quantifying Cy (and related metabolites) exposure measured as the
area under the concentration time curve (AUC) from zero to 24 hours both before (day -6) and
after transplant (day +3), and correlate exposure with incidence of acute and chronic GVHD,
and Adverse Events of Special Interest (AESIs); and determining whether immune activation or
polarization prior to or following Cy GVHD prophylaxis is associated with grade of acute or
chronic GVHD grade and AESIs. Safety objects include evaluating Cy administered, adverse
events of special interest (including deaths while on study therapy), selected laboratory
parameters (including time to neutrophil recovery), and immunosuppressant concomitant
medications administration. Initially, 20 participants (HCT recipients and their respective
haploidentical donors) will be enrolled with a subsequent 100 additional subjects enrolled.

Inclusion Criteria

Recipients and donors must meet all of the following applicable inclusion criteria to
participate in this study:

1. Informed consent and HIPAA authorization for release of personal health information
signed by the subject.

2. Age ≥ 18 years at the time of consent.

3. Subject is scheduled as a recipient or respective donor for the following procedure at
Levine Cancer Institute (LCI), and has been deemed a qualified candidate by his/her
physician, per LCI medical standards: haplo-identical hematopoietic stem cell
transplant (HCT) using a non-myeloablative regimen.

4. 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

Subjects meeting any of the criteria below may not participate in the study:

1. Recipient only: Does not have a respective donor who is willing to sign informed
consent for participation in this study.

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

3. Donor only: Does not have a respective recipient who is willing to sign informed
consent for participation in this study.
We found this trial at
1
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Charlotte, North Carolina 28211
Phone: 980-442-2017
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Charlotte, NC
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