Table 1.
Summary of efficacy for phase II of trial DFI12860
| Primary analysis of full analysis set (FAS) | Results | |
|---|---|---|
| Standard mobilization alone | Plerixafor + standard mobilization | |
| Descriptive statistics and estimate variability | ||
| Treatment group | ||
| Patients, n | 15 | 30 |
| Successful mobilization, % | 28.6 (8.4–58.1) | 80.0 (61.4–92.3) |
| Difference, % | 51.4 (18.5–84.3), p = .0019 | |
| Effect estimate per comparison | ||
| Secondary endpoint: Days of apheresis required to reach >2 × 106 CD34+ cells/kg | ||
| 1 | 1 | |
| Secondary endpoint: Patients reaching the threshold, % | 92.9 | 89.7 |
| Secondary endpoint: Total CD34+ yield, median, cells/kg | 10.15 × 106 | 9.13 × 106 |
| Secondary endpoint: Patients proceeding to transplant, % | 66.7 | 76.7 |
| Secondary endpoint: Patients successfully engrafting, % | 100 | 100 |
| Secondary endpoint: Patients with durable engraftment at 3, 6, 12, and 24 months after transplant, % | ||
| 3 months | 100 | 91.3 |
| 6 months | 90 | 87.0 |
| 12 months | 80.0 | 87.0 |
| 24 months | 80.0 | 82.6 |