Clinical trial · Observational
Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed/Refractory Large B-cell Lymphoma
Impact de la lymphodéplétion Dans la réponse Aux CAR T-cells Dans Les Lymphomes B Agressifs réfractaires ou en Rechute
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 necessary to for response and lymphodepletion type and exposure, notably to fludarabine, associated with expansion and response. The aim of the study is to analyse prospectivaly Fludarabine and cyclophosphamide exposure and correlate exposure to expansion, therapeutic response and survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAR T Cell | — | UNRESOLVED | — |
| Large B Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma
- interventionNames
- Other: Blood sampling
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- At 1 year
- description
- One year after the CAR T therapy
Secondary outcomes (21)
- measure
- Global response
- timeFrame
- At 1 month
- measure
- Complete response
- timeFrame
- At 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available