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The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orally Busulfan PK | Other | Evaluate the Pharmacokinetics of orally busulfan |
|
| Intravenously Busulfan PK | Other | Evaluate the Pharmacokinetics of intravenously busulfan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analyze the pharmacokinetics of busulfan for transplantation | Other | Evaluate the Bu pharmacokinetics (PK) when the drug will be received by P.O or I.V and we will establish the target "Area Under Curve- AUC" based on a single daily dose (test dose) before HSCT. The test dose of orally Bu is 1 mg/Kg and the blood samples are collected and processed in time: 0h, 30 min, 1h, 1,5h, 2h, 3h, 4h, 5h and 6h after drug intake. After extraction of the plasma samples busulfan, quantitative analyzes of busulfan on human plasma will be performed by the liquid chromatograph. For the patients that will receive intravenously busulfan, the test dose is 32 mg/m2 and blood samples are collected in time: 0h, 30', 45', 1h, 2h, 3h, 4h, 5h, 6h and 8h after drug intake. The dose during the conditioning will depend on the test dose and the AUC target. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Evaluation of 5-years overall survival in patients who underwent different formulations of busulfan during stem Cell Transplantation | 5 years |
| Cumulative incidence of relapse and non relapse mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iracema Esteves, investigator | Contact | (5511)963010921 | iestevesmed@yahoo.com.br | |
| Sandra Nakashima, nurse | Contact | (5511)21511128 | sandra.nakashima@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Nelson Hamerschlak, Doctor | Hospital Israelita Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | Recruiting | São Paulo | São Paulo | 05651901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31089278 | Derived | Esteves I, Santos FPS, Fernandes JF, Seber A, Oliveira JSR, Hamerschlak N, Kerbauy FR, S Andersson B, de Lima M. Pharmacokinetics analysis results are similar for oral compared to intravenous busulfan in patients undergoing hematopoietic stem cell transplantation, except for the earlier onset of mucositis. A controlled clinical study. Bone Marrow Transplant. 2019 Nov;54(11):1799-1804. doi: 10.1038/s41409-019-0521-5. Epub 2019 May 14. |
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Evaluate 5-years cumulative incidence of relapse and non relapse mortality in patients that underwent stem cell transplantation with busulfan in conditioning regimen
| 5 years |
| Disease Free Survival | Evaluate 1-year Disease Free Survival in patients that underwent stem cell transplantation with busulfan in conditioning regimen who enter complete remission after | 1 year |
| Toxicity | Evaluate hematological and non hematological toxicity in patients that underwent stem cell transplantation with busulfan in conditioning regimen | 1 year |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D009196 | Myeloproliferative Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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