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Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation

Phase 3
Open (Enrolling)
Acute Leukemia, Chronic Leukemia, Lymphoproliferative Disease, Myeloproliferative Disease, Immunodeficiency

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Trial Information

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

Inclusion Criteria:

- Diagnosis of hematologic or non-hematologic pathology using as part of the
conditioning regimen busulfan;

- Men, women and children regardless of age;

- Performance Status> 80 or ECOG <2;

- Total bilirubin <2 mg / dl and transaminases <3 times the upper limit of normal;

- Creatinine <1.5 mg / dl;

- LVEF> 50% by echocardiogram or MUGA at rest;

- Pulmonary function test with FEV1> 70%;

- Consent form signed before the start of any specific procedure.

Exclusion Criteria:

- Presence of infectious process in uncontrolled activity;

- Presence of psychiatric disorder;

- Pregnancy;

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dosing of plasmatic levels of busulfan

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nelson Hamerschlak, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Israelita Albert Einstein


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

December 2014

Related Keywords:

  • Acute Leukemia
  • Chronic Leukemia
  • Lymphoproliferative Disease
  • Myeloproliferative Disease
  • Immunodeficiency
  • Busulfan
  • plasmatic dosage
  • Stem Cell Transplantation
  • Immunologic Deficiency Syndromes
  • Leukemia
  • Lymphoproliferative Disorders
  • Myeloproliferative Disorders
  • Chronic Disease