Population Pharmacokinetics of the Nucleoside Analogues Clofarabine and Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (alloHCT)

Locations

1 United States site

Age

< 17 Years

Study type

Observational

Gender

All

Compensation

Unknown

About the study

Fludarabine and clofarabine are chemotherapy drugs used extensively in bone marrow
transplantation. The goal of this study is to determine what causes some children to have
different drug concentrations of clofarabine and fludarabine in their bodies and if drug
levels are related to whether or not a child experiences severe side-effects during their
bone marrow transplant. The hypothesis is that clinical and individual factors cause changes
in clofarabine and fludarabine drug levels in pediatric bone marrow transplant patients and
that high levels may cause severe side-effects.

participation requirements

– Children 0-17 years of age

– Undergoing alloHCT for the treatment of malignant or nonmalignant disorder

– Receiving clofarabine and fludarabine-based preparative regimen

participation restrictions

– Any child 7-17 years of age unwilling to provide assent

Locations

  • San Francisco, California, United States, University of California, San Francisco, 94143