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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 (PREV-CART)

4 augustus 2026 bijgewerkt door: Assistance Publique - Hôpitaux de Paris

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

228

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Age 16-80 years at inclusion
  2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma
  3. With gamma globulins <4g/L at the time of screening
  4. Receiving CD19-targeted autologous CAR-T cells (with AMM in their indication)
  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
  7. Informed consent signed by patient or legal representatives

Exclusion Criteria:

  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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Immunoglobulin Replacement therapy
Geneesmiddel: Immunoglobulin
IgRT 0.4g/Kg IV every 4 weeks for 12 months
Actieve vergelijker: Antibiotic prophylaxis
Geneesmiddel: antibiotic prophylaxis
PA following each center's guidelines, for 12 months

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Occurrence of recurrent infections
Tijdsspanne: At 12 months
Defined by at least 2 episodes requiring a curative systemic antibiotic treatment
At 12 months
Occurrence of a severe infection
Tijdsspanne: At 12 months
Defined by the need of hospitalization
At 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cumulative hazard of severe infections
Tijdsspanne: Up to 12 months
requiring hospitalization
Up to 12 months
Infection-free survival rate
Tijdsspanne: Up to 12 months
Up to 12 months
Occurrence of COVID19 infection
Tijdsspanne: Up to 12 months
Up to 12 months
Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CART cells
Tijdsspanne: Up to 12 months
Up to 12 months
Incidence of adverse events due to IgRT and/or PA
Tijdsspanne: Up to 12 months
Up to 12 months
Dosage of immune markers
Tijdsspanne: Up to 12 months
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts, at lymphodepletion
Up to 12 months
Dosage of immune markers
Tijdsspanne: At 1 month
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
At 1 month
Dosage of immune markers
Tijdsspanne: At 3 months
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
At 3 months
Dosage of immune markers
Tijdsspanne: At 6 months
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
At 6 months
Dosage of immune markers
Tijdsspanne: At 9 months
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
At 9 months
Dosage of immune markers
Tijdsspanne: At 12 months
IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts
At 12 months
Quality of life assessment
Tijdsspanne: At 3 months
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.
At 3 months
Quality of life assessment
Tijdsspanne: At 6 months
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.
At 6 months
Quality of life assessment
Tijdsspanne: At 9 months
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.
At 9 months
Quality of life assessment
Tijdsspanne: At 12 months
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.
At 12 months
Quality of life assessment
Tijdsspanne: At 3 months
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.
At 3 months
Quality of life assessment
Tijdsspanne: At 6 months
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.
At 6 months
Quality of life assessment
Tijdsspanne: At 9 months
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.
At 9 months
Quality of life assessment
Tijdsspanne: At 12 months
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.
At 12 months
Incremental Cost-Effectiveness Ratio (ICER)
Tijdsspanne: Up to 12 months
Up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2029

Studie voltooiing (Geschat)

1 september 2029

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APHP241013

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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