TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients
Recruiting
- Conditions
- allogeneic stem cell transplantationcyclosporineTDMAdverse drug reactions
- Registration Number
- NL-OMON27177
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age 18-65 inclusive
- AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
Exclusion Criteria
- Renal dysfunction (serum creatinine > 150 umol/L or clearance < 50 ml/min)
- Patients with active, uncontrolled infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Grade acute kidney injury<br /><br>- Grade nausea <br /><br>- Grade in tremor <br /><br>
- Secondary Outcome Measures
Name Time Method Adverse drug reactions <br /><br>- Headache <br /><br>- Hypertension<br /><br><br /><br>Clinical chemical parameters:<br /><br>- Glucose<br /><br>- Potassium<br /><br>- Magnesium<br /><br>- Total cholesterol<br /><br>- High-density lipoproteins<br /><br>- Liver function<br /><br><br /><br>Other parameters:<br /><br>- Grade GVHD<br /><br>- Minimal residual disease on day 28; 56; 84; 112; 140 ; 168<br /><br>- Engraftment<br /><br>- Quality of life (QoL) will be assessed by means of the validated questionnaires.<br />