Impact of fludarabine dosage on outcomes in large B-cell lymphoma patients treated with CAR T-cell therapy: a retrospective study of the CTIWP of the EBMT
Higher chemotherapy doses before CAR-T immunotherapy don't improve outcomes in lymphoma and may actually harm survival, clarifying optimal treatment intensity.
This large EBMT registry study (n=1498) definitively demonstrates that escalating fludarabine beyond standard dosing does not improve CAR-T outcomes in LBCL with tisagenlecleucel, and may worsen OS. Axicabtagene ciloleucel at standard lymphodepletion doses consistently outperformed both tisa-cel dose groups in PFS and OS, with higher ICANS as trade-off.
What the study was
- Study design
- Retrospective EBMT registry study; n=1498 LBCL patients (tisa-cel n=549, axi-cel n=949) treated 2019-2023; OS, PFS, relapse incidence compared by fludarabine dose groups
- Population
- Adults with relapsed/refractory large B-cell lymphoma treated with CD19 CAR-T (tisagenlecleucel or axicabtagene ciloleucel) at EBMT centers
- Sample size
- 1498
- Category
- Treatment Innovation
- Maturity
- Validated
- Journal
- Bone Marrow Transplantation
Why it surfaced
Largest registry-based analysis of fludarabine dosing in CAR-T therapy (n=1498, EBMT). Directly actionable finding: dose escalation of fludarabine does not improve and may harm outcomes in tisa-cel. Results have immediate clinical practice implications for lymphodepletion protocol design.
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