Preventing infections after CAR-T cell treatment for B cell leukemia or lymphoma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16-80 with B-cell acute lymphoblastic leukemia or B-cell lymphoma who receive CD19-targeted CAR-T cells and have low gammaglobulin. It compares immunoglobulin replacement with antibiotic prophylaxis to prevent infections.

Age

16-80 years

Sex

All sexes

Disease stage

B-cell acute lymphoblastic leukemia or B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma).

Earlier treatment

Must be receiving CD19-targeted autologous CAR-T cells.

Biomarker or test result

Gammaglobulin below 4g/L at the time of lymphodepletion.

Main reasons for not taking part

• History of intolerance to intravenous immunoglobulin
• Kidney failure (glomerular filtration rate below 30 mL/min)
• Liver failure, hepatitis, or high bilirubin or liver enzymes
• Existing serious acute infection
• Pregnant or breastfeeding

The registry criteria, word for word

What the trial wants to find out

To compare immunoglobulin replacement therapy (IgRT) to prophylactic antibiotic treatment (AP) following center’s guidelines in the prevention of the occurrence of clinically or microbiologically documented infections within 12 months following randomization, in patients 16-80 years old, treated by CAR-T cells therapy for B-ALL or BCL. The main trial endpoint is 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.