Table 1.
Characteristics of overall population and according to ITT (interquartile range).
| Early G-CSF n = 33 | Control n = 89 | p | ||||
|---|---|---|---|---|---|---|
| n | Statistics | n | Statistics | |||
| Age | Median (IQ) | 65 | (53–70) | 60 | 49–68 | 0.12 |
| >70 | 11 | 33% | 18 | 20.2% | 0.13 | |
| Sex | Male | 17 | 51.2% | 58 | 65.2 | 0.21 |
| Female | 16 | 48.5% | 31 | 34.8 | ||
| Histology | DLBCL | 24 | 72.7% | 73 | 82 | 0.47 |
| PMBL | 3 | 9.1% | 5 | 5.6 | ||
| tFL | 6 | 18.2% | 11 | 12.4 | ||
| DLBCL COO | GC | 10 | 41.7% | 37 | 52.9 | 0.48 |
| ABC | 14 | 58.3% | 33 | 47.1 | ||
| Refractory | Yes | 23 | 69.7% | 69 | 77.5 | 0.48 |
| No | 10 | 30.3% | 20 | 22.5 | ||
| Previous lines | 2 | 2-2 | 3 | 2-4 | <0.0001 | |
| Previous ASCT/ | 7 | 21% | 26 | 29% | 0.49 | |
| Previous AlloSCT | 0 | 0% | 0 | 0% | 1 | |
| At enrollment | ||||||
| PS | 0 | 11 | 33.3% | 40 | 44.9 | 0.5 |
| 1 | 18 | 54.6% | 41 | 46 | ||
| 2 | 4 | 12.1% | 8 | 9 | ||
| Elevated LDH | 24 | 72.7% | 42 | 47.2 | 0.021 | |
| Ann Arbor stage | III or IV | 27 | 81.8% | 69 | 77.5% | 0.60 |
| Extranodal sites | ≥2 | 11 | 33% | 27 | 30.3% | 0.75 |
| R-IPI | Very good | 0 | 0% | 6 | 6.74% | 0.059 |
| Good | 13 | 53.9% | 48 | 53.93% | ||
| Poor | 35 | 39.3% | 35 | 39.33% | ||
| IPI | 0 | 0 | 0% | 6 | 6.74% | 0.10 |
| I | 6 | 18.2% | 28 | 31.46% | ||
| II | 7 | 21.2% | 20 | 22.47% | ||
| III | 13 | 39.4% | 21 | 23.6% | ||
| IV | 7 | 21.2% | 10 | 11.24% | ||
| V | 0 | 0% | 4 | 4.49% | ||
| At lymphodepletion | ||||||
| PS | 0 | 7 | 21.2% | 43 | 48.3% | 0.047 |
| 1 | 17 | 51.52% | 32 | 36% | ||
| 2 | 6 | 18.2% | 11 | 12.4% | ||
| 3 | 3 | 9.1 | 3 | 3.37% | ||
| Elevated LDH | 17 | 51.52% | 27 | 30.34% | 0.051 | |
| Ann Arbor stage | III or IV | 26 | 78.8% | 70 | 78.7% | 0.98 |
| Extranodal sites ≥2 | 11 | 33.3% | 28 | 31.4% | 0.84 | |
| Status at lymphodepletion | Partial response | 7 | 21.2% | 19 | 21.3% | 0.98 |
| Stable disease | 5 | 15.2% | 14 | 15.7% | 0.93 | |
| Progression | 21 | 63.6% | 56 | 62.9% | 0.94 | |
| R-IPI | Very good | 1 | 3% | 10 | 11.24% | 0.068 |
| Good | 13 | 39.4% | 47 | 52.8% | ||
| Poor | 19 | 57.6% | 32 | 36% | ||
| IPI | 0 | 1 | 3% | 10 | 11.2% | 0.12 |
| I | 7 | 21.2% | 22 | 24.7% | ||
| II | 6 | 18.2% | 25 | 28.1% | ||
| III | 10 | 30.3% | 19 | 21.4% | ||
| IV | 9 | 27.3% | 10 | 11.2% | ||
| V | 0 | 0% | 3 | 3% | ||
| Prophylaxis | Antipneumocystis | 32 | 96.7% | 86 | 96.6% | 1 |
| Antiviral | 33 | 100% | 86 | 96.6% | 0.56 | |
| Bridging | No bridging | 5 | 15.2% | 13 | 14.6% | 0.94 |
| Low | 6 | 18.2% | 21 | 23.6% | 0.52 | |
| High | 22 | 66.6% | 55 | 61.7% | 0.62 | |
| CAR T product | Tisagencecleucel (kymriah) | 15 | 45.5% | 44 | 49.4% | 0.69 |
| Axicabtagene-ciloleucel (yescarta) | 18 | 54.4% | 45 | 50.6% | ||
| At infusion | ||||||
| Neutrophils | Median (IQ), G/L | 0.990 | (0.41–2.06) | 1.22 | (0.62–1.992) | 0.45 |
| Hemoglobin | median (IQ) g/L | 9.5 | (8.6–10.9) | 9.8 | 8.8–11.2 | 0.5 |
| Platelets | Median (IQ), G/L | 140 | (87–195) | 141 | 97–190 | 0.75 |
| CRP | >30 mg/L | 14 | 42.2% | 26 | 29.2% | 0.16 |
| Albumin | <35 g/L | 12 | 36.3% | 17 | 19.1% | 0.046 |
| Lymphocytes | Median (IQ) G/L | 0.02 | (0–0.03) | 0.04 | (0.02–0.06) | 0.002 |
| Ferritine | median(IQ) | 763 | (414–1084) | 721 | (361–1128) | 0.67 |
| LDH | >Nl | 17 | 51.5% | 27 | 30.3% | 0.036 |
| Hemotox score | ≥2 | 21 | 94% | 75 | 84.3% | 0.35 |