Investigation of fludarabine exposure in relation to individual renal function in patients with allogeneic hematopoietic stem cell transplantation and patients with CART cell therapy
Not Applicable
Recruiting
- Conditions
- Patients with allogeneic stem cell transplantation or CART cell therapy
- Registration Number
- DRKS00033126
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
•Adult, hospitalized patients of the Clinic and Polyclinic for Stem Cell Transplantation of the UKE who receive an allogeneic hematopoietic stem cell transplantation or CART cell therapy according to indication and whose therapy plan includes fludarabine
•Written informed consent of the patient
Exclusion Criteria
•Age < 18 years
•Absence of written informed consent of the patient
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of fludarabine exposure, measured as F-ara-A AUC, with creatinine- and cystatin C-based eGFR.
- Secondary Outcome Measures
Name Time Method •Development of hypotheses for the future optimization of renal-adapted dosing of fludarabine.<br>•Evaluation of possible influential factors such as concomitant medication on the relationship between fludarabine exposure and biomarker-based estimated kidney function.