TRough vs AUC Monitoring of cyclosporine: a randomized comparison of adverse drug reactions in allogeneic stem cell recipients

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2015
INTERVENTION: CsA monitoring and dose adjustments will be based on trough levels (arm 1) or abbreviated AUC[0‐12] (arm 2) CONDITION: Allogeneic stem cell transplantation, Cyclosporine, Adverse Drug Events ; ; PRIMARY OUTCOME: ‐ Grade acute kidney injury; ; ‐ Grade nausea ; ; ‐ Grade in tremor ; ; SECONDARY OUTCOME: Adverse drug reactions ; ; ‐ Headache ; ; ‐ Hypertension ; ; ; ; Clinical chemical parameters: ; ; ‐ Glucose ; ; ‐ Potassium ; ; ‐ Magnesium ; ; ‐ Total cholesterol ; ; ‐ High‐density lipoproteins ; ; ‐ Liver function ; ; ; ; Other parameters: ; ; ‐ Grade GVHD ; ; ‐ Minimal residual disease on day 28; 56; 84; 112; 140 ; 168 ; ; ‐ Engraftment ; ; ‐ Quality of life (QoL) will be assessed by means of the validated questionnaires. ; 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 ‐ Written Informed Consent
Epistemonikos ID: 5b5cf962e0d4970980858d687e48ffd44116f42b
First added on: Aug 23, 2024