NCT01800643Unknown2 期
Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dosing of plasmatic levels of busulfan
研究概览
简要总结
The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation
详细描述
- Busulfan is an alkylating antineoplastic agent used commonly during the conditioning regimen in patients 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 conditioning. Busulfan toxicities depends on the "Area Under Curve" and Concentration Steady State (CSS).
- The investigators randomized in groups according to the route of drug administration: per oral and intravenously. Dose test will be performed before conditioning and othe pharmacokinetics (Pk) study will be made in the first day of conditioning. The test dose of P.O busulfan will be 1 mg/Kg/dose and 32 mg/m2 for I.V busulfan. The target dose of busulfan during the conditioning will depends on the Pk obtained during the test dose. In the first day of regimen, other samples will be analysed and the new AUC will be adjusted. We will have a control group who have never performed monitoring before (retrospective group)
- Test Dose for oral busulfan will be performed with peripheral blood samples at the time: 0h (before taking busulfan), 30', 1h, 1,5h, 2h, 3h, 4h, 5h and 6h. In the first day of conditioning other samples will be collected again in the same moments.
- Test dose for I.V busulfan will be performed on time 0h, 30', 45', 1h, 2h, 3h, 4h, 5h, 6h and 8h after receiving I.V busulfan. If the patients will receive I.V busulfan during conditioning, 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 (4º C/ 3200 rpm/10 minutes) and analysed.
- Patients will be monitored with pharmacokinetic's drug and clinical outcomes. The investigators will evaluate acute and chronic toxicities after Stem Cell Transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Presence of infectious process in uncontrolled activity;
- •Presence of psychiatric disorder;
- •Pregnancy;
研究组 & 干预措施
Orally Busulfan PK
Other
Evaluate the Pharmacokinetics of orally busulfan
干预措施: Analyze the pharmacokinetics of busulfan for transplantation (Other)
Intravenously Busulfan PK
Other
Evaluate the Pharmacokinetics of intravenously busulfan
干预措施: Analyze the pharmacokinetics of busulfan for transplantation (Other)
结局指标
主要结局
Dosing of plasmatic levels of busulfan
时间窗: 2 years
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
次要结局
- Disease Free Survival(1 year)
- Overall Survival(5 years)
- Cumulative incidence of relapse and non relapse mortality(5 years)
- Toxicity(1 year)
研究者
Iracema Esteves
MD
Hospital Israelita Albert Einstein
研究点 (1)
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