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”
Key facts
- Where
- Angers, Brest, Caen, Clermont-Ferrand, Grenoble Cedex 9, Lille Cedex, Limoges Cedex 1, Nantes, Nice, Paris, Pessac, Saint-Priest-en-Jarez, Toulouse Cedex 9, Tours és Vandoeuvre Les Nancy, FranciaországSee the 15 sites
- Phase
- 3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországToborzás még nem indult
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de Caen NormandieCaen, FranciaországToborzás még nem indult
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországToborzás még nem indult
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de NantesNantes, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de NiceNice, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux de ParisParis, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországToborzás még nem indult
- Centre Hospitalier Régional Universitaire de ToursTours, FranciaországToborzás még nem indult
- CHRU De NancyVandoeuvre Les Nancy, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique Hopitaux De Paris
- Trial code
- EU 2025-521571-30-00
- Record updated
- 2026. április 13.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 16-80 years at inclusion; B-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma); With gammaglobulin <4g/L at the time of lymphodepletion; Receiving CD19-targeted autologous CAR-T cells; Patients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion; Contraceptive measures for concerned patients (cf part 6); Informed consent signed by patient or legal representatives.
Exclusion: Participation in another interventional study or being in the exclusion period at the end of a previous study; Any medical history of intolerance to intravenous immunoglobulin; With renal failure calculated glomerular filtrate rate <30 mL / min; With existing serious acute infection; With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N; Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial; No health insurance coverage; Females who are pregnant or breastfeeding.