Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed/Refractory Large B-cell Lymphoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

    Before and after fludarabine infusion

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Adult patients with relapsed or refractory diffuse large B-cell lymphoma1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival

One year after the CAR T therapy

Time frame
At 1 year

Secondary outcomes

1

Global response

Time frame
At 1 month
2

Complete response

Time frame
At 1 month
3

Global response

Time frame
At 3 months
4

Complete response

Time frame
At 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: