NCT03555851

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
113mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jul 2018Aug 2035

First Submitted

Initial submission to the registry

May 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2033

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2035

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

15.2 years

First QC Date

May 2, 2018

Last Update Submit

January 6, 2026

Conditions

Leukemia, Not Otherwise SpecifiedLeukemia, Other

Outcome Measures

Primary Outcomes (1)

  • Comparison of Cy cMax Values

    Evaluation and comparison of average Day 3 Cy cMax values between subjects who experience acute GVHD versus subjects who do not experience acute GVHD

    Approx. 24 mos

Secondary Outcomes (4)

  • Incidence of chronic GVHD

    Approx. 24 mos

  • Cy exposure

    Approx. 10 days

  • Toxicities

    Approx. 180 days

  • Pharmacogenetics of Cy-related genes

    Approx. 24 mos

Study Arms (2)

Recipient

Cyclophosphamide

Drug: CyclophosphamideOther: Specimen collection

Donor

Specimen collection

Other: Specimen collection

Interventions

CyclophosphamideDRUG

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.

Recipient
Specimen collectionOTHER

Buccal swabs will be obtained from donors for pharmacogenomics.

DonorRecipient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who are scheduled as a recipient or respective donor for the following hematopoietic stem cell transplants (HCT): haplo-identical donor HCT, match related donor (MRD) HCT, matched unrelated donor (MUD) HCT.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs, whole blood

MeSH Terms

Conditions

Leukemia

Interventions

CyclophosphamideSpecimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Aleksander Chojecki, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Parke

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

June 14, 2018

Study Start

July 13, 2018

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

August 1, 2035

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)