Investigations into the influence of fludarabine exposure on the outcome of patients after CAR-T cell therapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033974

Enrollment

200

Registered

2024-04-09

Start date

2024-04-10

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

C90 C83

Interventions

Group 1: Adult, hospitalized patients of the participating clinics who are receiving CAR-T cell therapy for an aggressive B-cell lymphoma or multiple myeloma and whose lymphodepletion contains fludara

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: - Age < 18 years - Lack of written consent of the patient

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• Correlation of fludarabine exposure with malignant disease response at day 30 and 90 after CAR-T cell therapy • Correlation of fludarabine exposure with progression-free survival 12 months after CAR-T cell therapy • Correlation of fludarabine exposure with incidence of CRS (Cytokine release syndrom) • Correlation of fludarabine exposure with incidence of ICANS (immune effector cell-associated neurotoxicity syndrome) • Correlation of fludarabine exposure with cytopenia on day 30 after CAR-T cell therapy • Correlation of fludarabine exposure with biomarker-based estimated renal function • Evaluation of possible influencing factors such as comedication on the correlation between fludarabine exposure and biomarker-based estimated renal function	—

Measure

Time frame

• Correlation of fludarabine exposure with malignant disease response at day 30 and 90 after CAR-T cell therapy • Correlation of fludarabine exposure with progression-free survival 12 months after CAR-T cell therapy • Correlation of fludarabine exposure with incidence of CRS (Cytokine release syndrom) • Correlation of fludarabine exposure with incidence of ICANS (immune effector cell-associated neurotoxicity syndrome) • Correlation of fludarabine exposure with cytopenia on day 30 after CAR-T cell therapy • Correlation of fludarabine exposure with biomarker-based estimated renal function • Evaluation of possible influencing factors such as comedication on the correlation between fludarabine exposure and biomarker-based estimated renal 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: Jun 11, 2026