About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Adult patients aged 18 and over treated with commercial CAR T-cells (Lisocabtagene maraleucel, Tisagenlecleucel, or Axicabtagene ciloleucel) for relapsed or refractory diffuse large B-cell lymphoma.
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sampling
Other interventionBefore and after fludarabine infusion
Treatment groups
Trial outcomes
Primary outcomes
Progression Free Survival
One year after the CAR T therapy
Secondary outcomes
Global response
Complete response
Global response
Complete response
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: