Medical history before leniolisib and latest time point of treatment
| Patient . | P1 . | P2 . | P3 . | P4 . | P5 . | P6 . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . |
| BMI, kg/m2 | 22.5 | 26.9 | 24.6 | 24.3 | 27 | 36.5 | 18.9 | 27.6 | 18.0 | 22.0 | 21.4 | 25.2 |
| IRT use | Yes | No | Yes | Yes, decreased dose | Yes | Yes | No | No | Yes | Yes, decreased dose | Yes | No |
| Spleen 3D volume∗, cm3 (normal range, 159-314 cm3) | 978.78 | 782.80 | 792.04 | 392.96 | 385.83 | 128.20 | 782.21 | 467.21 | 419.84 | 212.89 | 721.83 | 336.20 |
| Liver 3D volume, cm3 | 1849.59 | 1669.64 | 1438.04 | 1375.58 | 1349.16 | 1475.39 | 1398.93 | 1143.93 | 1396.21 | 1274.87 | 1817.80 | 1878.66 |
| Index lymph node SPD, cm2 | 24.52 | 5.49 | 19.26 | 14.43 | 12.35 | 3.09 | 7.48 | 4.12 | 2.58 | 1.35 | 8.58 | 3.89 |
| EBV/CMV, copies per mL | ND/<344† | ND/ND | ND/ND | ND/ND | 740/<344 | 2000/ND | ND/ND | ND/ND | ND/ND | 24.61/ND | ND†/380 | ND/ND |
| Platelets, ×109/L (normal range, ×109/L) | 129 (140-370)‡ | 144 (161-347)§ | 53 (140-370)‡ | 148 (173-369)§ | 103 (140-370)‡ | 224 (173-369)§ | 134 (140-370)‡ | 213 (161-347)§ | 121 (140-370)‡ | 260 (150-400)§ | 123 (140-370)‡ | 211 (150-370)§ |
| Neutrophils, ×109/L (lower limit of normal, 1.5 ×109/L)ǁ | 2.9 | 2.1 | 0.4 | 1.68 | 2.9 | 4.04 | 1.9 | 2.4 | 2.1 | 3.63 | 3.1 | 4.18 |
| Lymphocytes, ×109/L (normal range, 109/L) | 1.0 (0.8-3.3)‡ | 1.64 (1.32-3.57)§ | 0.6 (0.8-3.3)‡ | 0.95 (1.18-3.74)§ | 0.7 (0.8-3.3)‡ | 2.03 (1.18-3.74)§ | 0.5 (0.8-3.3)‡ | 0.85 (1.32-3.57)§ | 0.6 (0.8-3.3)‡ | 1.16 (0.8-4)§ | 0.8 (0.8-3.3)‡ | 0.94 (0.5-5)§ |
| Hemoglobin, g/L (normal range, g/L) | 132 (130-175)‡ | 150 (139-175)§ | 114 (113-156)‡ | 124 (112-157)§ | 120 (113-156)‡ | 131 (112-157)§ | 111 (130-175)‡ | 163 (139-175)§ | 143 (130-175)‡ | 152 (135-175)§ | 136 (130-175)‡ | 153.1 (138.6-169.2)§ |
| Patient . | P1 . | P2 . | P3 . | P4 . | P5 . | P6 . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . | DFT baseline . | Latest time point . |
| BMI, kg/m2 | 22.5 | 26.9 | 24.6 | 24.3 | 27 | 36.5 | 18.9 | 27.6 | 18.0 | 22.0 | 21.4 | 25.2 |
| IRT use | Yes | No | Yes | Yes, decreased dose | Yes | Yes | No | No | Yes | Yes, decreased dose | Yes | No |
| Spleen 3D volume∗, cm3 (normal range, 159-314 cm3) | 978.78 | 782.80 | 792.04 | 392.96 | 385.83 | 128.20 | 782.21 | 467.21 | 419.84 | 212.89 | 721.83 | 336.20 |
| Liver 3D volume, cm3 | 1849.59 | 1669.64 | 1438.04 | 1375.58 | 1349.16 | 1475.39 | 1398.93 | 1143.93 | 1396.21 | 1274.87 | 1817.80 | 1878.66 |
| Index lymph node SPD, cm2 | 24.52 | 5.49 | 19.26 | 14.43 | 12.35 | 3.09 | 7.48 | 4.12 | 2.58 | 1.35 | 8.58 | 3.89 |
| EBV/CMV, copies per mL | ND/<344† | ND/ND | ND/ND | ND/ND | 740/<344 | 2000/ND | ND/ND | ND/ND | ND/ND | 24.61/ND | ND†/380 | ND/ND |
| Platelets, ×109/L (normal range, ×109/L) | 129 (140-370)‡ | 144 (161-347)§ | 53 (140-370)‡ | 148 (173-369)§ | 103 (140-370)‡ | 224 (173-369)§ | 134 (140-370)‡ | 213 (161-347)§ | 121 (140-370)‡ | 260 (150-400)§ | 123 (140-370)‡ | 211 (150-370)§ |
| Neutrophils, ×109/L (lower limit of normal, 1.5 ×109/L)ǁ | 2.9 | 2.1 | 0.4 | 1.68 | 2.9 | 4.04 | 1.9 | 2.4 | 2.1 | 3.63 | 3.1 | 4.18 |
| Lymphocytes, ×109/L (normal range, 109/L) | 1.0 (0.8-3.3)‡ | 1.64 (1.32-3.57)§ | 0.6 (0.8-3.3)‡ | 0.95 (1.18-3.74)§ | 0.7 (0.8-3.3)‡ | 2.03 (1.18-3.74)§ | 0.5 (0.8-3.3)‡ | 0.85 (1.32-3.57)§ | 0.6 (0.8-3.3)‡ | 1.16 (0.8-4)§ | 0.8 (0.8-3.3)‡ | 0.94 (0.5-5)§ |
| Hemoglobin, g/L (normal range, g/L) | 132 (130-175)‡ | 150 (139-175)§ | 114 (113-156)‡ | 124 (112-157)§ | 120 (113-156)‡ | 131 (112-157)§ | 111 (130-175)‡ | 163 (139-175)§ | 143 (130-175)‡ | 152 (135-175)§ | 136 (130-175)‡ | 153.1 (138.6-169.2)§ |
3D, 3-dimensional; BMI, body mass index; CMV, cytomegalovirus; ND, not detected; SPD, sum of product of diameters.
Spleen, liver, and lymph node data were collected from the CSR. To minimize radiation exposure, computerized tomography or magnetic resonance imaging were completed around year 1 of treatment (either extension day 168 or 252). The index lymph node SPD was determined by multiplying the length and width of ≤6 nodes and calculating the sum.
Experimental day 29 and 1 were used for P1 and P6, respectively.
Normal ranges are from the DFT.20 Values outside the normal range are italicized.
Normal ranges are from the OLE study and varied per patient. Values outside normal range are italicized.
ASH guidelines were used to determine neutropenia (lower limit of normal, 1.5 × 109/L). Values outside normal range are italicized.