Pharmacokinetics of treosulfan in children undergoing hematopoietic stem cell transplantatio
Completed
- Conditions
- Patients undergoing an allogeneic stem cell transplantation due to a malignant or non-malignant immuno-hematologic disease.Chemotherapeutic drug prior to stem cell transplantation
- Registration Number
- NL-OMON41480
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Pediatric patients undergoing stem cell transplantation
Receiving treosulfan as part of their conditioning regimen
Permanent venous access
Exclusion Criteria
None
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the population pharmacokinetic parameters of<br /><br>treosulfan, defined as treosulfan clearance, treosulfan half-life, area under<br /><br>the concentration time curve over 24 hours and inter- and intrapatient<br /><br>variability in PK parameters in the patient population.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In the second part of the study the PK parameters of treosulfan will be<br /><br>correlated with clinical outcome of the patient in. The following parameters<br /><br>will be taken into account.<br /><br>• Stem cell engraftment<br /><br>• 100-day treatment related toxicity.<br /><br>• Survival<br /><br>• Relapse<br /><br>• Occurrence of GVHD acute and chronic.</p><br>
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