HUMAN NORMAL IMMUNOGLOBULIN (IV) for B-cell acute lymphoblastic leukaemia|B-cell lymphoma|Diffuse large B-cell lymphoma|Mantle cell lymphoma|Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- 1.\tAge 16-80 years at inclusion\n- 2.\tB-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma)\n- 3.\tWith gammaglobulin <4g/L at the time of lymphodepletion\n- 4.\tReceiving CD19-targeted autologous CAR-T cells\n- 5.\tPatients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.\n- 6.\tContraceptive measures for concerned patients (cf part 6)\n- 7.\tInformed consent signed by patient or legal representatives"}

Exclusion criteria

• {"criterion_text":"- 1.\tAny medical history of intolerance to intravenous immunoglobulin\n- 2.\tWith renal failure calculated glomerular filtrate rate <30 mL / min;\n- 3.\tWith hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N\n- 4.\tWith existing serious acute infection\n- 5.\tContraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial\n- 6.\tNo health insurance coverage\n- 7.\tFemales who are pregnant or breastfeeding\n- 8.\tParticipation in another interventional study or being in the exclusion period at the end of a previous study"}

Primary endpoints

• {"endpoint_text":"- A composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.","definition_or_measurement_approach":"Composite outcome: recurrent infections defined as at least 2 episodes requiring a curative systemic antibiotic treatment; severe infection defined by the need for hospitalization; measured between randomization and month 12 (M12)."}

Secondary endpoints

• {"endpoint_text":"- Cumulative hazard of severe (requiring hospitalization) infections within 12 months","definition_or_measurement_approach":"Cumulative hazard of severe infections (those requiring hospitalization) assessed within 12 months."}
• {"endpoint_text":"- Infection-free survival rate at M12","definition_or_measurement_approach":"Infection-free survival at month 12 (M12)."}
• {"endpoint_text":"- Occurrence of COVID19 infection within 12 months","definition_or_measurement_approach":"Occurrence/incidence of SARS-CoV-2 infection within 12 months."}
• {"endpoint_text":"- Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CAR-T cells within 12 months","definition_or_measurement_approach":"Cumulative incidence of hospital readmissions for infectious episodes within 12 months after CAR-T infusion hospital discharge."}
• {"endpoint_text":"- Incidence of adverse events due to IgRT and/or PA between randomization and M12","definition_or_measurement_approach":"Incidence of adverse events attributed to immunoglobulin replacement therapy (IgRT) and/or prophylactic antibiotherapy (PA) between randomization and month 12."}
• {"endpoint_text":"- Measures of IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts at lymphodepletion, M1, M3, M6, M9, M12","definition_or_measurement_approach":"Immunological measures (IgA, IgG, IgM and lymphocyte subsets CD19/CD4/CD8) at predefined timepoints: lymphodepletion, month 1, 3, 6, 9, 12."}
• {"endpoint_text":"- Quality of life measured on QLQ-C30 and EQ5D5L","definition_or_measurement_approach":"Patient-reported quality of life assessed using QLQ-C30 and EQ-5D-5L instruments."}
• {"endpoint_text":"- Cost effectiveness and cost utility: incremental cost effectiveness/utility ratios","definition_or_measurement_approach":"Health economic outcomes: incremental cost-effectiveness and cost-utility ratios comparing interventions."}

France

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

24

Number Of Sites

20

Number Of Participants

228

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France