Investigation of fludarabine exposure in relation to individual renal function in patients with allogeneic hematopoietic stem cell transplantation and patients with CART cell therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033126

Enrollment

Registered

2023-12-04

Start date

2023-11-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with allogeneic stem cell transplantation or CART cell therapy

Interventions

Group 1: Adult, hospitalized patients of the Clinic and Polyclinic for Stem Cell Transplantation of the UKE, who receive allogeneic stem cell transplantation or CART cell therapy according to indicati

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: • Age < 18 years • Absence of written informed consent of the patient

Design outcomes

Primary

Measure	Time frame
Correlation of fludarabine exposure, measured as F-ara-A AUC, with creatinine- and cystatin C-based eGFR.	—

Secondary

Measure	Time frame
• Development of hypotheses for the future optimization of renal-adapted dosing of fludarabine. • Evaluation of possible influential factors such as concomitant medication on the relationship between fludarabine exposure and biomarker-based estimated kidney function.	—

Countries

Germany

Contacts

Public ContactClaudia Langebrake

Universitätsklinikum Hamburg-Eppendorf

clangebrake@uke.de040 / 741056583

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026