Status:
UNKNOWN
Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Hospital Israelita Albert Einstein
Conditions:
Acute Leukemia
Chronic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation
Detailed Description
* 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 ha...
Eligibility Criteria
Inclusion
- 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
- Presence of infectious process in uncontrolled activity;
- Presence of psychiatric disorder;
- Pregnancy;
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01800643
Start Date
March 1 2010
End Date
December 1 2014
Last Update
December 3 2014
Active Locations (1)
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1
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05651901