Table 1.

Patient characteristics associated with neurotoxicity

Neurotoxicity gradeGrades 0–2Grades 3–4TotalUnivariate P
Overall, n (%)31 (58)22 (42)53
Age, n (%)18–309 (29%)5 (22.7%)14 (26.4%)0.04
31–6013 (41.9%)16 (72.7%)29 (54.7%)
>609 (29%)1 (4.5%)10 (18.9%)
Gender, n (%)Female7 (22.6%)6 (27.3%)13 (24.5%)0.753
Male24 (77.4%)16 (72.7%)40 (75.5%)
Weight (kg)78 (10.1–145.1)80 (60.4–126)78 (10.1–145.1)0.752
BMI (kg/m2)<2511 (35.5%)8 (36.4%)19 (35.8%)1
25–3013 (41.9%)9 (40.9%)22 (41.5%)
>307 (22.6%)5 (22.7%)12 (22.6%)
Lines of prior therapy212 (38.7%)9 (40.9%)21 (39.6%)1
38 (25.8%)5 (22.7%)13 (24.5%)
≥411 (35.5%)8 (36.4%)19 (35.8%)
Prior HSCTNo20 (64.5%)14 (63.6%)34 (64.2%)1
Yes11 (35.5%)8 (36.4%)19 (35.8%)
Disease burdenaHigh13 (41.9%)19 (86.4%)32 (60.4%)0.002
Low18 (58.1%)3 (13.6%)21 (39.6%)
Philadelphia chromosomeNo20 (64.5%)18 (81.8 %)38 (71.7%)0.223
Yes11 (35.5%)4 (18.2%)15 (28.3%)
Conditioning chemotherapyFlu/Cyb5 (16.1%)5 (22.7%)10 (18.9%)0.724
Cy alonec26 (83.9%)17 (77.3%)43 (81.1 %)
CAR T-cell dose (CAR T cells/kg)1 × 10611 (35.5%)10 (45.5%)21 (39.6%)0.752
3 × 10619 (61.3%)12 (54.5%)31 (58.5%)
4 × 1051 (3.2%)1 (1.9%)
Cytokine release syndromeNone (grade 0)14 (45.2%)4 (18.2%)18 (34%)0.001
Mild (grade 1–2)16 (51.6%)8 (36.4%)24 (45.3%)
Severe (grade 3–5)1 (3.2%)10 (45.5%)d11 (20.8%)
  • Abbreviations: BMI, body mass index; HSCT, hematopoietic stem cell transplant; Flu, fludarabine; Cy, cyclophosphamide.

  • aAll patients had disease burden assessed by bone marrow biopsy and/or radiographic studies prior to CAR T-cell infusion. High disease burden is defined as bone marrow blasts ≥5% or radiographically evident extramedullary disease. Low disease burden is defined as <5% bone marrow blasts.

  • bFludarabine 25 mg/m2/d for 3–5 days and cyclophosphamide 1.5–3 g/m2/d for 1 day.

  • cCyclophosphamide 1.5–3 g/m2/d for 1 day.

  • dIncludes 1 patient who developed grade 5 CRS.