Investigations into the influence of fludarabine exposure on the outcomeof patients after CAR-T cell therapy
Not Applicable
Recruiting
- Conditions
- C90C83Multiple myeloma and malignant plasma cell neoplasmsNon-follicular lymphoma
- Registration Number
- DRKS00033974
- Lead Sponsor
- niversitätsklinikum Hamburg Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
•Adult, hospitalized patients of the participating clinics receiving CAR T-
cell therapy according to indication and whose conditioning plan
includes fludarabine
•Diagnosis of multiple myeloma or aggressive B-cell lymphoma
•Written consent of the patients
Exclusion Criteria
- Age < 18 years
- Lack of written 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 CAR-T cell expansion (maximum value measured within the first 4 weeks after CAR-T cell infusion)
- Secondary Outcome Measures
Name Time Method •Correlation of fludarabine exposure with malignant disease response at <br> day 30 and 90 after CAR-T cell therapy<br>•Correlation of fludarabine <br> exposure with progression-free survival 12 months after CAR-T cell <br> therapy<br>•Correlation of fludarabine exposure with incidence of CRS (Cytokine <br> release syndrom)<br>•Correlation of fludarabine exposure with incidence of ICANS (immune <br> effector cell-associated neurotoxicity syndrome)<br>•Correlation of fludarabine exposure with cytopenia on day 30 after CAR-T <br> cell therapy<br>•Correlation of fludarabine exposure with biomarker-based estimated renal <br> function<br>•Evaluation of possible influencing factors such as comedication on the <br> correlation between fludarabine exposure and biomarker-based estimated <br> renal function