Chimeric Antigen Receptor T-cell TherapyPhase 3PREV-CARTNCT07754682
Immunoglobulin Replacement Therapy (IgRT) Versus Antibiotic Prophylaxis (PA) in Patients Treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B Cell Acute Lymphoblastic Leukemia or a B Cell Lymphoma
A Phase 3 study testing Immunoglobulin and antibiotic prophylaxis in people with Chimeric Antigen Receptor T-cell Therapy and B Cell Acute Lymphoblastic Leukemia (B-ALL), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
B cell (CD19) targeted chimeric antigen receptor modified T Cells (CAR-T) has transformed treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) or B-cell lymphoma (BCL). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Chimeric Antigen Receptor T-cell Therapy, B Cell Acute Lymphoblastic Leukemia (B-ALL), B Cell Lymphoma
- What is being tested?
- Immunoglobulin and antibiotic prophylaxis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-80 years at inclusion
- B-cell acute lymphoblastic leukemia or a B-cell lymphoma
- With gamma globulins <4g/L at the time of screening
- Receiving CD19-targeted autologous CAR-T cells (with AMM in their indication)
- 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
- Informed consent signed by patient or legal representatives
Who cannot join
- Any medical history of intolerance to intravenous immunoglobulin
- With renal failure calculated glomerular filtrate rate <30 mL / min;
- With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
- With existing serious acute infection
- Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
- No health insurance coverage
- Females who are pregnant or breastfeeding
- Participation in another interventional study or being
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
B cell (CD19) targeted chimeric antigen receptor modified T Cells (CAR-T) has transformed treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) or B-cell lymphoma (BCL).
Because patients receiving CAR-T often present uncontrolled disease and have undergone several lines of treatment, they may be deeply immuno-depressed and prone to infections. Hypogammaglobulinemia were reported in 74% of patients preCAR-T cells infusion (Hill JA, et al. Blood Rev. 2019 Nov). CART cells also results in depletion of normal CD19+ B cells and hypogammaglobulinemia as an on-target, off tumor toxicity.
Because CAR-T cells can persist for years, patients are exposed to infectious complications secondary to long-term Bcell aplasia and severe hypogammaglobulinemia (<4g/l). Data from patients who received rituximab (CD20-specific monoclonal antibody) show that patients with severe hypogammaglobulinemia experienced recurrent bronchitis, sinusitis, pneumonia, and rarely, enteroviral meningoencephalitis. In patients receiving CAR T-cells, infection density is 0.55-0.67 infections/100 days3,5 at risk after the first month with a majority of respiratory and ENT (earsnose-throat) infections. To prevent infections, anti-bacterial prophylaxis (AP) based on local guidelines is often used in patients treated by CAR-T cells, with the risk of subsequent resistance. Otherwise, intravenous immunoglobulin replacement therapy (IgRT) is authorized by the French authorities for patients with secondary antibody deficiencies who developed severe or recurrent infections after appropriate antimicrobial therapy, if IgG levels <4g/l. However, although IgRT as primary prophylaxis (PP) have no approval, they are used as PP after CAR T-cells by many centers, with no data supporting such a strategy. The benefit of IgRT over AP as a primary prophylaxis in the setting of CD19 CAR-T cells therapy should be demonstrated given its burden for patients and care, as well as its cost and the risk of Ig shortage. Therefore, this multi-centric prospective randomized openlabel study aims to assess the benefits of IgRT versus AP as PP in patients with secondary antibody deficiencies.
- Conditions
- Chimeric Antigen Receptor T-cell Therapy, B Cell Acute Lymphoblastic Leukemia (B-ALL), B Cell Lymphoma, Antibiotic Prophylaxis, Immunoglobulin Therapy
- Being tested
- Immunoglobulin, antibiotic prophylaxis
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoglobulinDrug
IgRT 0.4g/Kg IV every 4 weeks for 12 months
antibiotic prophylaxisDrug
PA following each center's guidelines, for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Immunoglobulin Replacement therapy | Experimental | Not described Receives: Drug: Immunoglobulin |
| Antibiotic prophylaxis | Active comparator | Not described Receives: Drug: antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of recurrent infections
Defined by at least 2 episodes requiring a curative systemic antibiotic treatment
Measured: At 12 months
Occurrence of a severe infection
Defined by the need of hospitalization
Measured: At 12 months
Secondary outcomes (20)
Cumulative hazard of severe infections
requiring hospitalization
Measured: Up to 12 months
Infection-free survival rate
Measured: Up to 12 months
Occurrence of COVID19 infection
Measured: Up to 12 months
Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CART cells
Measured: Up to 12 months
Incidence of adverse events due to IgRT and/or PA
Measured: Up to 12 months
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts, at lymphodepletion
Measured: Up to 12 months
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
Measured: At 1 month
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
Measured: At 3 months
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
Measured: At 6 months
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
Measured: At 9 months
Dosage of immune markers
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
Measured: At 12 months
Quality of life assessment
EQ5D5L : standardized measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score typically ranges from values below 0 (health states considered worse than death) to 1.0 (full health), depending on the country-specific value set. Higher scores indicate better health-related quality of life.
Measured: At 3 months
Quality of life assessment
EQ5D5L : standardized measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score typically ranges from values below 0 (health states considered worse than death) to 1.0 (full health), depending on the country-specific value set. Higher scores indicate better health-related quality of life.
Measured: At 6 months
Quality of life assessment
EQ5D5L : standardized measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score typically ranges from values below 0 (health states considered worse than death) to 1.0 (full health), depending on the country-specific value set. Higher scores indicate better health-related quality of life.
Measured: At 9 months
Quality of life assessment
EQ5D5L : standardized measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score typically ranges from values below 0 (health states considered worse than death) to 1.0 (full health), depending on the country-specific value set. Higher scores indicate better health-related quality of life.
Measured: At 12 months
Quality of life assessment
EORTC QLQ-C30 : cancer-specific questionnaire designed to assess health-related quality of life in patients with cancer. Scores are linearly transformed to a 0-100 scale. For the Global Health Status/Quality of Life scale and the functional scales, higher scores indicate better quality of life and functioning. For symptom scales, higher scores indicate greater symptom burden and poorer health status.
Measured: At 3 months
Quality of life assessment
EORTC QLQ-C30 : cancer-specific questionnaire designed to assess health-related quality of life in patients with cancer. Scores are linearly transformed to a 0-100 scale. For the Global Health Status/Quality of Life scale and the functional scales, higher scores indicate better quality of life and functioning. For symptom scales, higher scores indicate greater symptom burden and poorer health status.
Measured: At 6 months
Quality of life assessment
EORTC QLQ-C30 : cancer-specific questionnaire designed to assess health-related quality of life in patients with cancer. Scores are linearly transformed to a 0-100 scale. For the Global Health Status/Quality of Life scale and the functional scales, higher scores indicate better quality of life and functioning. For symptom scales, higher scores indicate greater symptom burden and poorer health status.
Measured: At 9 months
Quality of life assessment
EORTC QLQ-C30 : cancer-specific questionnaire designed to assess health-related quality of life in patients with cancer. Scores are linearly transformed to a 0-100 scale. For the Global Health Status/Quality of Life scale and the functional scales, higher scores indicate better quality of life and functioning. For symptom scales, higher scores indicate greater symptom burden and poorer health status.
Measured: At 12 months
Incremental Cost-Effectiveness Ratio (ICER)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chimeric Antigen Receptor T-cell TherapyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III randomized two-parallel arms, open-label multicentric design in patients treated by CD19-targeted CAR-T Cells for a B-ALL or a BCL, randomly allocated in a 1:1 ratio to receive either IgRT or PA.
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754682
- Sponsor's protocol ID
- APHP241013
- Acronym
- PREV-CART
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07754682
- Acronym / sponsor ID
- PREV-CART / APHP241013
- Conditions
- Chimeric Antigen Receptor T-cell Therapy, B Cell Acute Lymphoblastic Leukemia (B-ALL), B Cell Lymphoma, Antibiotic Prophylaxis, Immunoglobulin Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
B cell (CD19) targeted chimeric antigen receptor modified T Cells (CAR-T) has transformed treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) or B-cell lymphoma (BCL).
Because patients receiving CAR-T often present uncontrolled disease and have undergone several lines of treatment, they may be deeply immuno-depressed and prone to infections. Hypogammaglobulinemia were reported in 74% of patients preCAR-T cells infusion (Hill JA, et al. Blood Rev. 2019 Nov). CART cells also results in depletion of normal CD19+ B cells and hypogammaglobulinemia as an on-target, off tumor toxicity.
Because CAR-T cells can persist for years, patients are exposed to infectious complications secondary to long-term Bcell aplasia and severe hypogammaglobulinemia (<4g/l). Data from patients who received rituximab (CD20-specific monoclonal antibody) show that patients with severe hypogammaglobulinemia experienced recurrent bronchitis, sinusitis, pneumonia, and rarely, enteroviral meningoencephalitis. In patients receiving CAR T-cells, infection density is 0.55-0.67 infections/100 days3,5 at risk after the first month with a majority of respiratory and ENT (earsnose-throat) infections. To prevent infections, anti-bacterial prophylaxis (AP) based on local guidelines is often used in patients treated by CAR-T cells, with the risk of subsequent resistance. Otherwise, intravenous immunoglobulin replacement therapy (IgRT) is authorized by the French authorities for patients with secondary antibody deficiencies who developed severe or recurrent infections after appropriate antimicrobial therapy, if IgG levels <4g/l. However, although IgRT as primary prophylaxis (PP) have no approval, they are used as PP after CAR T-cells by many centers, with no data supporting such a strategy. The benefit of IgRT over AP as a primary prophylaxis in the setting of CD19 CAR-T cells therapy should be demonstrated given its burden for patients and care, as well as its cost and the risk of Ig shortage. Therefore, this multi-centric prospective randomized openlabel study aims to assess the benefits of IgRT versus AP as PP in patients with secondary antibody deficiencies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III randomized two-parallel arms, open-label multicentric design in patients treated by CD19-targeted CAR-T Cells for a B-ALL or a BCL, randomly allocated in a 1:1 ratio to receive either IgRT or PA.
| Arm | Type | Receives |
|---|---|---|
| Immunoglobulin Replacement therapy | Experimental | Drug: Immunoglobulin |
| Antibiotic prophylaxis | Active comparator | Drug: antibiotic prophylaxis |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 16-80 years at inclusion
- B-cell acute lymphoblastic leukemia or a B-cell lymphoma
- With gamma globulins <4g/L at the time of screening
- Receiving CD19-targeted autologous CAR-T cells (with AMM in their indication)
- Patients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.
Key exclusion criteria (8 listed)
- Any medical history of intolerance to intravenous immunoglobulin
- With renal failure calculated glomerular filtrate rate <30 mL / min;
- With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
- With existing serious acute infection
- Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunoglobulinIgRT 0.4g/Kg IV every 4 weeks for 12 months | Drug | Immunoglobulin Replacement therapy |
| antibiotic prophylaxisPA following each center's guidelines, for 12 months | Drug | Antibiotic prophylaxis |
Primary outcome
Occurrence of recurrent infections
Time frame: At 12 months
Defined by at least 2 episodes requiring a curative systemic antibiotic treatment
Occurrence of a severe infection
Time frame: At 12 months
Defined by the need of hospitalization
20 secondary outcomes
Cumulative hazard of severe infections
Time frame: Up to 12 months
Infection-free survival rate
Time frame: Up to 12 months
Occurrence of COVID19 infection
Time frame: Up to 12 months
Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CART cells
Time frame: Up to 12 months
Incidence of adverse events due to IgRT and/or PA
Time frame: Up to 12 months
Dosage of immune markers
Time frame: Up to 12 months
Dosage of immune markers
Time frame: At 1 month
Dosage of immune markers
Time frame: At 3 months
Dosage of immune markers
Time frame: At 6 months
Dosage of immune markers
Time frame: At 9 months
Dosage of immune markers
Time frame: At 12 months
Quality of life assessment
Time frame: At 3 months
Quality of life assessment
Time frame: At 6 months
Quality of life assessment
Time frame: At 9 months
Quality of life assessment
Time frame: At 12 months
Quality of life assessment
Time frame: At 3 months
Quality of life assessment
Time frame: At 6 months
Quality of life assessment
Time frame: At 9 months
Quality of life assessment
Time frame: At 12 months
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunoglobulin and antibiotic prophylaxis in people with Chimeric Antigen Receptor T-cell Therapy and B Cell Acute Lymphoblastic Leukemia (B-ALL), run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence Rabian, MD (+33 1 42 38 51 27 ext. +33, florence.rabian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of recurrent infections (time frame: At 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.