TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients (TRAM-study)
Completed
- Conditions
- allogeneic stemcel transplantation10024324
- Registration Number
- NL-OMON39871
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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)
* Planned allogeneic stem cell transplantation
* Related or unrelated donor with a 7/8 or 8/8 HLA match (HLA A, B, C, DRB1) or 9/10 or 10/10 MUD match
* WHO performance status 0-2
Exclusion Criteria
* Renal dysfunction (serum creatinine > 150 umol/L or clearance < 50 ml/min)
* Patients with active, uncontrolled infection
* Cord Blood transplantation
* Patients with progressive disease in case of MM, CLL, NHL, HL
* Patients with > 5% marrow blasts in case of AML, ALL, CML
* Patients with EMD in case of AML, ALL, CML
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse drug reactions (headache, tremor, renal dysfunction, hypertension).<br /><br>Quality of life (QoL) will be assessed by means of validated questionnaires.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of life (QoL) will be assessed by means of validated questionnaires.</p><br>