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Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how genes, how the body handles medicine, and types of immune cells affect cyclophosphamide given after a stem cell transplant. The goal is to help tailor doses to fight cancer while limiting graft-versus-host disease, when donor cells attack the patient's body. It is for adults receiving certain stem cell transplants at Levine Cancer Institute and their donors.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older when you agree to join.
  • Sign forms agreeing to join and allowing the use of your personal health information.
  • Be approved by your doctor to receive or donate for a stem cell transplant at Levine Cancer Institute.
  • The transplant must use a half-matched donor, a matched related donor, or a matched unrelated donor.
  • The transplant must use a less intense treatment plan before transplant.
  • Recipients must plan to get cyclophosphamide after transplant.
  • Be able to understand and follow study steps for the whole study, as judged by the study doctor.

Who can't join

  • Recipients with a half-matched or matched related donor cannot join if their donor will not agree to join. This does not apply to recipients with matched unrelated donors.
  • Recipients cannot join if they received an experimental drug within the 30 days before treatment day −6.
  • Half-matched or matched related donors cannot join if their recipient will not agree to join. Matched unrelated donors do not need to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 (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. 4. Recipient only: Planned post-transplant cyclophosphamide 5. 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 (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. 2. Recipient only: Treatment with any investigational drug within 30 days prior to day -6 of treatment 3. 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.

Study sites (1)

NC