Earlier intervention to prevent severe ICANS in Axi-cel

Exploring the effect of early administration of tocilizumab + dexamethasone on patients highly risked for severe CAR-T related-AEs after Axi-cel infusion. - PIXEL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041250141

Enrollment

335

Registered

2025-12-12

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe immune effector cell-associated neurotoxicity syndrome (ICANS) Malignant lymphoma, immune effector cell-associated neurotoxicity syndrome, CAR-T cell therapy

Interventions

1 Initial Treatment, Day 1 to 4 Administer tocilizumab 8 mg per kg once and dexamethasone 10 mg three times daily TID from Day 0 or 1 to Day 4. The TID dosing of dexamethasone is continued until Day 4

D013256

corticosteroid, dexamethasone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria: (1) Target Disease: Relapsed or refractory (R/R) malignant lymphoma eligible for Axi-cel therapy. (2) Sex: Male or Female. (3) Age: 18 years or older. (4) Treatment: Patients scheduled to receive Axi-cel therapy for the above-mentioned disease. This study involves the secondary use of information from cases registered in [Validation of an early prediction for severe ICANS after CAR-T infusion by initial fever.] No new information will be collected for this study. (5) Informed Consent: Patients who have understood the nature of the study and have provided written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients receiving glucocorticoids or other immunosuppressants for the prophylaxis of CRS/ICANS before the onset of CRS. (2) Patients receiving steroids or other immunosuppressants prior to lymphodepleting chemotherapy. (3) Patients who are unable to provide written informed consent or lack the capacity to consent.

Design outcomes

Primary

Measure	Time frame
The success rate of severe ICANS prevention in the study treatment group.	—

Secondary

Measure	Time frame
Cumulative steroid dose (from Axi-cel infusion until hospital discharge or Day 30, whichever comes first). Overall Survival (OS). Progression-Free Survival (PFS). Best overall response to Axi-cel for malignant lymphoma in all subjects. Incidence and severity of CRS in all subjects. Incidence and severity of ICANS in all subjects. Incidence of adverse events in all subjects. Comparison of the above endpoints between the study treatment group and the observational group. Analysis of baseline characteristics between groups (including pre-observation laboratory values and maximum CRP and ferritin levels from Day 0-5).	—

Measure

Time frame

Cumulative steroid dose (from Axi-cel infusion until hospital discharge or Day 30, whichever comes first). Overall Survival (OS). Progression-Free Survival (PFS). Best overall response to Axi-cel for malignant lymphoma in all subjects. Incidence and severity of CRS in all subjects. Incidence and severity of ICANS in all subjects. Incidence of adverse events in all subjects. Comparison of the above endpoints between the study treatment group and the observational group. Analysis of baseline characteristics between groups (including pre-observation laboratory values and maximum CRP and ferritin levels from Day 0-5).

—

Contacts

Public ContactHiroya Wakabayashi

Nagoya University Graduate School of Medicine, Department of Hematology and Oncology

wakabayashi.h1@med.nagoya-u.ac.jp+81-52-744-2145

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026