Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation
- Busulfan is an alkylating antineoplastic agent used commonly during the conditioning
regimen (CR) in patient undergoing Haematopoietic Stem Cell Transplantation (HSCT). Due
to the fact that this drug has a variable metabolism in different individuals, the
investigators performed the plasmatic dosage of chemotherapy before starting the
conditioning regimen (test dose) as a way to predict the best dose to them during the
CR. Busulfan toxicities depends on the "Area Under Curve" and Concentration Steady
State (CSS) that the investigators see by the pharmacokinetic study.
- The investigators randomized in two groups according to the route of drug
administration: Oral and intravenous. For both the investigators did test dose before
HSCT and in the first day of CR. The dosage of test dose was 1 mg/Kg/dose for oral
formulation of busulfan and 32 mg/m2 for intravenous busulfan. The dose of busulfan
that the investigators give for the patients during the CR depends on the
pharmacokinetics obtained during the test dose. On the first day of CR the
investigators calculated plasma levels again to make adjustments according the "Area
Under Curve" target. This is a good way to know the population pharmacokinetic study of
busulfan before and during HSCT.
- To test dose analysis pharmacokinetic and analysis during CR for oral busulfan, the
investigators collect peripheral blood samples at the time: 0h (before taking
busulfan), 30', 1h, 1,5h, 2h, 3h, 4h, 5h and 6h after taking this drug. To test dose
for intravenous busulfan the investigators collect on time 0h, 30', 45', 1h, 2h, 3h,
4h, 5h, 6h and 8h after receiving busulfan. If the patient is receiving intravenous
busulfan during CR, the blood samples should be collected on time 0h, 30', 1h, 2h, 3h,
4h, 5h, 6h, 7h and 8h after taking busulfan. The blood samples will be centrifuged (4ยบ
C/ 3200 rpm/10 minutes) and analysed.
- Since pharmacokinetic study until clinical outcomes, patients will be monitored. The
investigators will evaluate acute and chronic toxicities after Stem Cell
Transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Dosing of plasmatic levels of busulfan
To study the effectiveness dosing of busulfan plasma levels during the administration of orally busulfan or intravenous prior to HSCT (test dose) and correlate with the respective plasma measurements in the first days of conditioning
2 years
Yes
Nelson Hamerschlak, Doctor
Study Chair
Hospital Israelita Albert Einstein
United States: Food and Drug Administration
Busulfan-2013
NCT01800643
March 2010
December 2014
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