Study of Clofarabine and Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation (HCT)
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Infectious Disease, HIV / AIDS, Anemia, Anemia, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology, Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 8/3/2018 |
| Start Date: | February 2016 |
| End Date: | April 2019 |
| Contact: | Danna D Chan, Pharm.D. |
| Email: | danna.chan@ucsf.edu |
| Phone: | 4155964594 |
Population Pharmacokinetics of the Nucleoside Analogues Clofarabine and Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (alloHCT)
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.
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.
Fludarabine and clofarabine are nucleoside analogs with potent antitumor and
immunosuppressive properties used in conditioning regimens of pediatric allogeneic
hematopoietic cell transplantation (alloHCT) to promote stem cell engraftment.
This is a single-center, prospective, non-interventional pharmacokinetic (PK) study
investigating the clinical pharmacology of combination nucleoside analogue therapy in 24
children undergoing alloHCT at UCSF Benioff Children's Hospital.
Patients would receive clofarabine and fludarabine regardless of whether or not they decide
to consent to PK sampling.
Clofarabine and fludarabine doses will not be adjusted based on PK data.
The investigators will apply the combination of a limited sampling strategy and population PK
methodologies to determine specific factors influencing clofarabine and fludarabine exposure
in pediatric alloHCT recipients and identify exposure-response relationships.
Subjects will undergo PK sampling of clofarabine and fludarabine drug concentrations over the
duration of combination therapy (3 to 5 days).
To evaluate sources of variability impacting clofarabine and fludarabine exposure clinical
data will be obtained from the patient's medical chart on each day of PK sampling.
To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity,
and survival data will be collected through day 100 post-transplant.
immunosuppressive properties used in conditioning regimens of pediatric allogeneic
hematopoietic cell transplantation (alloHCT) to promote stem cell engraftment.
This is a single-center, prospective, non-interventional pharmacokinetic (PK) study
investigating the clinical pharmacology of combination nucleoside analogue therapy in 24
children undergoing alloHCT at UCSF Benioff Children's Hospital.
Patients would receive clofarabine and fludarabine regardless of whether or not they decide
to consent to PK sampling.
Clofarabine and fludarabine doses will not be adjusted based on PK data.
The investigators will apply the combination of a limited sampling strategy and population PK
methodologies to determine specific factors influencing clofarabine and fludarabine exposure
in pediatric alloHCT recipients and identify exposure-response relationships.
Subjects will undergo PK sampling of clofarabine and fludarabine drug concentrations over the
duration of combination therapy (3 to 5 days).
To evaluate sources of variability impacting clofarabine and fludarabine exposure clinical
data will be obtained from the patient's medical chart on each day of PK sampling.
To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity,
and survival data will be collected through day 100 post-transplant.
Inclusion Criteria:
- Children 0-17 years of age
- Undergoing alloHCT for the treatment of malignant or nonmalignant disorder
- Receiving clofarabine and fludarabine-based preparative regimen
Exclusion Criteria:
- Any child 7-17 years of age unwilling to provide assent
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