Clinical trial · Interventional
Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
- 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)
Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data are available for population from America, Europe and Japan or Korea in Asia, there are no data in Chinese population. It is shown that high Bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct the pharmacokinetic study in Chinese population.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Iv-Busulfan
- description
- iv busulfan 1.6mg/kg given q12h
- interventionNames
- Drug: Busulfan
Primary outcomes (1)
- measure
- Area Under Curve (AUC)
- timeFrame
- predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose
- description
- busulifan blood concentration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * patient with acute myeloid or lymphoblastic leukemia in 1st or second remission * age 18-55 years * with inform consent * no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage * HLA matched related (6/6) or unrelated donors (at least 8/10) Exclusion Criteria: * age less than 18 years or over 56 years * HLA mismatched related donor * liver function/renal function damage (over 2 X upper normal range) * with mental disease
References
Publications (0)
Data not yet available