Reduction in Number of Tumor Cells
| No. of Tumor Cells . | CD34-Selected Arm (n = 28) . | Unselected Arm (n = 19) . |
|---|---|---|
| PBPC product (×106) | ||
| Mean ± SEM | 31.9 ± 13.8 | 95.6 ± 52.6 |
| Median | 2.6 | 2.3 |
| Range | 0-363.9 | 0-930.3 |
| CD34-selected product (×106) | ||
| Mean ± SEM | 0.07 ± 0.04 | NA |
| Median | 0 | |
| Range | 0-1.2 | |
| CD34-depleted product (×106) | ||
| Mean ± SEM | 39.5 ± 15.2 | NA |
| Median | 9.9 | |
| Range | 0-375.4 | |
| Log depletion of tumor cells | n = 24 | |
| Mean ± SEM | 3.29 ± 0.26 | NA |
| Median | 3.10 | |
| Range | 1.56-6.02 |
| No. of Tumor Cells . | CD34-Selected Arm (n = 28) . | Unselected Arm (n = 19) . |
|---|---|---|
| PBPC product (×106) | ||
| Mean ± SEM | 31.9 ± 13.8 | 95.6 ± 52.6 |
| Median | 2.6 | 2.3 |
| Range | 0-363.9 | 0-930.3 |
| CD34-selected product (×106) | ||
| Mean ± SEM | 0.07 ± 0.04 | NA |
| Median | 0 | |
| Range | 0-1.2 | |
| CD34-depleted product (×106) | ||
| Mean ± SEM | 39.5 ± 15.2 | NA |
| Median | 9.9 | |
| Range | 0-375.4 | |
| Log depletion of tumor cells | n = 24 | |
| Mean ± SEM | 3.29 ± 0.26 | NA |
| Median | 3.10 | |
| Range | 1.56-6.02 |
The number of tumor cells was assessed in the first leukaphereses using the patient-specific VH primers. The clonal Ig sequence was identified for 28 patients and 19 patients in the CD34-selected and unselected arms, respectively. The number of tumor cells before processing (PBPC product) and after processing (CD34-selected and CD34-depleted products) was assessed in the CD34-selected arm. The number of tumor cells in the PBPC product before cryopreservation was assessed in the unselected arm. There was no significant difference between the arms in the number of tumor cells in the PBPC product (P = .957, Wilcoxon rank sum test). For patients in the CD34-selected arm with detectable tumor cells in the PBPC product, the log depletion of tumor cells after processing on the CEPRATE SC System was calculated.
Abbreviation: NA, not applicable.