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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”
EU CTIS ID: 2025-521571-30-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 16-80 years at inclusion
- 2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma)
- 3. With gammaglobulin <4g/L at the time of lymphodepletion
- 4. Receiving CD19-targeted autologous CAR-T cells
- 5. Patients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.
- 6. Contraceptive measures for concerned patients (cf part 6)
You likely can't join if
- 1. Any medical history of intolerance to intravenous immunoglobulin
- 2. With renal failure calculated glomerular filtrate rate <30 mL / min;
- 3. With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
- 4. With existing serious acute infection
- 5. Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
- 6. No health insurance coverage
See the full eligibility criteria
- 1. Age 16-80 years at inclusion
- 2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma)
- 3. With gammaglobulin <4g/L at the time of lymphodepletion
- 4. Receiving CD19-targeted autologous CAR-T cells
- 5. Patients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.
- 6. Contraceptive measures for concerned patients (cf part 6)
- 7. Informed consent signed by patient or legal representatives
- 1. Any medical history of intolerance to intravenous immunoglobulin
- 2. With renal failure calculated glomerular filtrate rate <30 mL / min;
- 3. With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
- 4. With existing serious acute infection
- 5. Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
- 6. No health insurance coverage
- 7. Females who are pregnant or breastfeeding
- 8. Participation in another interventional study or being in the exclusion period at the end of a previous study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.