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

Earlier intervention to prevent severe ICANS in Axi-cel (PIXEL)

Kiyoi Hitoshi

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

65 Tsurumai-cho, Showak-ku, Nagoya, Aichi, JAPAN

kiyoi@med.nagoya-u.ac.jp

Wakabayashi Hiroya

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

65 Tsurumai-cho, Showak-ku, Nagoya, Aichi, JAPAN

+81-52-744-2145

wakabayashi.h1@med.nagoya-u.ac.jp

Recruiting

Jan. 20, 2026

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

(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.

Both

Severe immune effector cell-associated neurotoxicity syndrome (ICANS)

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.
2 Dexamethasone Taper
If the fever resolves by Day 4 and there are no symptoms of ICANS, reduce dexamethasone to 10 mg once daily QD on Day 5 and Day 6.
3 Dexamethasone Discontinuation
If the patient remains afebrile and shows no symptoms of ICANS on Day 6, discontinue dexamethasone from Day 7 onwards.
4 Dexamethasone Continuation or Taper
If fever more than 38.0 celcius persists on Day 4, continue dexamethasone at the same dose 10 mg TID. The day after the fever resolves, reduce the dose to 10 mg QD. If fever does not recur after this reduction, discontinue dexamethasone on the following day.
5 Management of Recurrent Fever
In scenarios 2 or 4, if fever recurs after reducing dexamethasone to 10 mg QD, resume dexamethasone at 10 mg TID. Subsequent management will follow the same steps as described in rule 4.
6 Treatment Discontinuation
If dexamethasone administration is not completed by Day 30, the study treatment will be discontinued.
7 Tocilizumab Administration
From Day 0 or 1 to Day 4, repeated administration of tocilizumab is not recommended, however, another dose of tocilizumab is acceptable total 2 doses maximum.
8 Dose Rounding
Rounding of doses up or down for dexamethasone and tocilizumab should follow the standard clinical practice at each institution but must remain within a 20 percent range.
Management of ICANS
9 If Grade 1 ICANS develops: Continue the current treatment regimen until ICANS resolves.
10 If the dexamethasone dose was TID at the onset of Grade 1 ICANS, reduce it to QD on the day after ICANS resolves. If ICANS does not recur, discontinue dexamethasone on the following day.
11 If the dexamethasone dose was QD at the onset of Grade 1 ICANS, discontinue it on the day after ICANS resolves.
12 If no dexamethasone was being administered at the onset of Grade 1 ICANS, administer dexamethasone 10mg QD and subsequent management will follow the same steps as described in rule 11.

13 If Grade 2 ICANS develops: Administer dexamethasone 10 mg four times daily (QID) and continue until improvement.
14 When ICANS improves to Grade 1, reduce dexamethasone to 10 mg QD on the following day. When ICANS resolves completely, discontinue dexamethasone on the following day.

Malignant lymphoma, immune effector cell-associated neurotoxicity syndrome, CAR-T cell therapy

corticosteroid, dexamethasone

C000722498

D013256

The success rate of severe ICANS prevention in the study treatment group.

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).

+81-52-744-2479

Nov. 28, 2025

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