PREV-CART - “A multicentric phase III randomized clinical trial open-label, comparing immunoglobulin replacement therapy (IgRT) and antibiotic prophylaxis (AP) in patients treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B cell acute lymphoblastic leukemia or a B cell lymphoma”

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 228
• 15 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (15)

Sites in registry order. Save your city in your profile to sort them by distance.

Are you the coordinator? Confirm the details