Clinical trial · Interventional
Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation
NCT01800643CI-TRIAL-00016222unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chronic Leukemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Immunodeficiency | — | UNRESOLVED | — |
| Lymphoproliferative Disease | — | UNRESOLVED | — |
| Myeloproliferative Disease | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analyze the pharmacokinetics of busulfan for transplantation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Orally Busulfan PK
- description
- Evaluate the Pharmacokinetics of orally busulfan
- interventionNames
- Other: Analyze the pharmacokinetics of busulfan for transplantation
- type
- OTHER
- label
- Intravenously Busulfan PK
- description
- Evaluate the Pharmacokinetics of intravenously busulfan
- interventionNames
- Other: Analyze the pharmacokinetics of busulfan for transplantation
Primary outcomes (1)
- measure
- Dosing of plasmatic levels of busulfan
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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;
References
Publications (1)
- DERIVEDEsteves 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. PMID 31089278