A Pharmacokinetic Study of Melphalan in Children

Completed · Phase 1

Conditions studied: Hematopoietic Stem Cell Transplantation

In brief

The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important component of HSCT preparative regimens, but can be associated with significant toxicity. PK data is a powerful clinical tool that, when used to develop individualized treatment plans for a specific patient, may ultimately increase the likelihood of selecting the right dose for the right patient and/or of reducing the number of adverse drug events. The investigators' goal is to establish baseline pediatric melphalan PK data. These data may be used for patient specific dosing of melphalan in the future to minimize toxicity and improve transplant outcomes.

Key facts

Study ID

NCT02390544

Run by

Children's Hospital Medical Center, Cincinnati

People needed

34

Starts

2015-05-08

Expected to finish

2018-09-23

Last updated by the study team

2021-08-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing either allogeneic RIC HSCT, or autologous transplant containing melphalan as part of the preparative regimen at CCHMC will be included.

You may not qualify if…

• Failure to sign informed consent, or inability to undergo informed consent process.
• It is not medically advisable to obtain the specimens necessary for this study.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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