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

NCT06988085 | Not Yet Recruiting

• 1 other identifier: APHP221165
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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 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

Large B Cell Lymphoma; CAR T Cell

Keywords

Large B cell lymphoma; CAR T cell; Lymphodepletion; Fludarabine exposure

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  One year after the CAR T therapy

  At 1 year

Secondary Outcomes (21)

• Global response

  At 1 month

• Complete response

  At 1 month

• Global response

  At 3 months

• Complete response

  At 3 months

• Overall survival

  At 1 year

Study Arms (1)

Adult patients with relapsed or refractory diffuse large B-cell lymphoma

Other: Blood sampling

Interventions

Blood sampling OTHER

Before and after fludarabine infusion

Adult patients with relapsed or refractory diffuse large B-cell lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• Weight ≤ 50 kg
• Out-of-specification reinfusion product
• Person under guardianship or curatorship, or deprived of liberty by judicial or administrative decision
• Patient's opposition to the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples Before infusion of fludarabine and cyclophosphamide 30 min after fludarabine infusion 1h after fludarabine infusion 3h after fludarabine infusion 7h after fludarabine infusion 9h after fludarabine infusion 1h after fludarabine infusion

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 23, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05