No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
120 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for
This trial is looking for adults who are receiving stem cell transplants for leukemia. Participants will have their treatment adjusted based on specific personal and genetic factors to improve outcomes and reduce side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have given my consent to participate in the study.
I am scheduled to receive a stem cell transplant at Levine Cancer Institute.
I will receive post-transplant cyclophosphamide treatment.
I can understand and follow the study procedures.
You may not be able to join if
I do not have a willing donor for my transplant.
I have taken any investigational drug in the past 30 days.
My donor does not have a willing recipient for the transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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City
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Status
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 …
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.
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