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”

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-04-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministry of Health, PHRC-K2024, INCA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 7

1. To compare the incidence of severe infections (grade 3-4)
2. To compare the hospital readmission for infections
3. To compare the safety of IgRT versus PA
4. To compare the Cost effectiveness of both interventions
5. To compare the immune reconstitution after CAR-T cells
6. To compare quality of life
7. To compare the incidence of SARS COV 2 infection

Conditions and MedDRA coding

Young Adults and adults with R/R B-cell acute lymphoblastic leukemia (BCP-ALL) or a B cell lymphoma (BCL)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Age 16-80 years at inclusion
2. 2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma)
3. 3. With gammaglobulin <4g/L at the time of lymphodepletion
4. 4. Receiving CD19-targeted autologous CAR-T cells
5. 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. 6. Contraceptive measures for concerned patients (cf part 6)
7. 7. Informed consent signed by patient or legal representatives

Exclusion criteria 8

1. 1. Any medical history of intolerance to intravenous immunoglobulin
2. 2. With renal failure calculated glomerular filtrate rate <30 mL / min;
3. 3. With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
4. 4. With existing serious acute infection
5. 5. Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
6. 6. No health insurance coverage
7. 7. Females who are pregnant or breastfeeding
8. 8. Participation in another interventional study or being in the exclusion period at the end of a previous study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 8

1. - Cumulative hazard of severe (requiring hospitalization) infections within 12 months
2. - Infection-free survival rate at M12
3. - Occurrence of COVID19 infection within 12 months
4. - Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CAR-T cells within 12 months
5. - Incidence of adverse events due to IgRT and/or PA between randomization and M12
6. - Measures of IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts at lymphodepletion, M1, M3, M6, M9, M12
7. - Quality of life measured on QLQ-C30 and EQ5D5L
8. - Cost effectiveness and cost utility: incremental cost effectiveness/utility ratios

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Florence RABIAN

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Florence RABIAN

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications