Table 2.
Engraftment and toxicities at all dose levels.
| Application of HDCT/ASCT | Results |
|---|---|
| BeEAM + BV 1 protocols given as planned, n (%) | 12 (100%) |
| Transplanted CD34+ cells, ×106/kg b.w., median (range) | 5.6 (2.8–11.5) |
| Interval to hematological recovery, days, median (range) | |
| Tc 2 > 20 × 109/L | 15 (10–28) |
| Tc > 50 × 109/L | 26 (16–86) |
| Tc > 100 × 109/L | 40 (25–86) |
| ANC 3 > 0.5 × 109/L | 11 (8–17) |
| ANC > 1.0 × 109/L | 12 (10–25) |
| Peripheral blood product use, median (range) | |
| RBC units 4 | 3 (0–9) |
| Tc units 2 | 4 (2–8) |
| Duration of Hospitalization, d, median (range) | 23 (22–56) |
| Adverse events | |
| Patients with at least one AE 5 (all grades), n (%) | 12 (100%) |
| Patients with at least one AE (grade III–IV), n (%) | 4 (33%) |
| Patients with more than one AE (all grades), n (%) | 7 (58%) |
| Severity of AEs, graded by CTCAE 6, median (range) | 1 (1–4) |
| AEs 5 possibly, probably, or definitely related to trial treatment, n (%) | 1 (3%) |
| Adverse events by type, n (%) | |
| Mucosal 7 | 1 (3%) |
| Infectious 8 | 27 (90%) |
| Other 9 | 2(7%) |
| Infections | |
| Patients with at least one febrile episode (>38.0 °C), n (%) | 12 (100%) |
| Febrile episodes (>38.0 °C), median (range) | 2 (1–4) |
| Patients with at least 1 identified pathogen, n (%) | 7 (58%) |
| Patients with >1 identified pathogen, n (%) | 1 (8%) |
| Bacteria, Gram-positive 10,11, n (%) | 5 (42%) |
| Bacteria, Gram-negative 10,12, n (%) | 3 (25%) |
| Viral, n (%) | 0 (0%) |
| Fungal, n (%) | 0 (0%) |
1 Brentuximab vedotin; 2 thrombocytes; 3 absolute neutrophil count; 4 red blood cells; 5 adverse event; 6 common terminology criteria for adverse events; 7 oral mucositis (n = 1, grade III); 8 febrile neutropenia (n = 1, grade III); pneumonia (n = 2, grade II and 2, grade III); sepsis (n = 2, grade IV); 9 steroid-induced diabetes mellitus (n = 1, grade III); paralytic ileus (n = 1, Grade III); 10 identified using cultures of blood (n = 6), urine (n = 1), and a CVK tip (n = 1); 11 coagulase negative Streptococci (3), Corynebacterium (1); 12 E. cloacae (1), E. coli (2).