Status:
NOT_YET_RECRUITING
Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed/Refractory Large B-cell Lymphoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Large B Cell Lymphoma
CAR T Cell
Eligibility:
All Genders
18+ years
Brief Summary
CAR T cells therapy has transformed the prognostic of relapsed/refractory large B cells lymphomas. Relapse however is still high and multiple causes have been studied. CAR expansion seems to be necess...
Detailed Description
Currently, a standard dose of fludarabine and cyclophosphamide is administered according to the type of CAR T-cells used. For Tisa-cel, a dose of 25 mg/m²/day of fludarabine is administered from Day ...
Eligibility Criteria
Inclusion
- Adult patient aged 18 years and older
- Treated with commercial CAR T-cells (Lisocabtagene maraleucel, Tisagenlecleucel, or Axicabtagene ciloleucel), with standard lymphodepletion consisting of Fludarabine and Cyclophosphamide
- Presenting with aggressive large B-cell lymphoma that is refractory or has relapsed after at least one line of treatment
- Creatinine clearance \> 50 ml/min (Cockcroft CKD-EPI)
Exclusion
- Weight ≤ 50 kg
- Out-of-specification reinfusion product
- Individual participating in another study with an ongoing exclusion period at the time of inclusion
- Person under guardianship or curatorship, or deprived of liberty by judicial or administrative decision
- Patient's opposition to the study
Key Trial Info
Start Date :
May 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06988085
Start Date
May 30 2025
End Date
May 30 2027
Last Update
May 23 2025
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