Results of the 43 HR patients who underwent HSCT in CR1
| . | Protocol-specified HSCT . | Protocol-unspecified HSCT, n = 5 . | P* . | |
|---|---|---|---|---|
| UCBD, n = 32 . | MFD, n = 6 . | |||
| FCM-MRD at TP3 | ||||
| Negative | 22 | 6 | 3 | |
| Positive | 1 | 0 | 0 | |
| Not evaluated | 9 | 0 | 2 | |
| Days from registration to HSCT | ||||
| Median (range) | 156 (135-194) | 185 (138-196) | 163 (150-190) | .27 |
| Donor | ||||
| UCBD | 32 | — | 4 | |
| MFD | — | 6 (5 BM and 1 PBSC) | 0 | |
| Haploidentical mother | — | — | 1 | |
| Conditioning regimen | ||||
| BU + ETP + CY | 32 | 6 | 3 | |
| FLU + MEL + other | — | — | 2 | |
| GVHD prophylaxis | ||||
| TAC + sMTX | 22 | 4 | 5 | |
| CsA + sMTX | 10 | 1 | 0 | |
| MTX only | 0 | 1 | 0 | |
| Infused cell dose, ×107/kg | ||||
| Median (range) | 12.3 (0.113-115) | 41.5 (19.3-69.0) | — | .0077 |
| Neutrophil engraftment† | ||||
| n | 31 | 6 | 5 | |
| Median (range), d | 17 (12-39) | 15.5 (14-17) | — | .0024 |
| Platelet engraftment‡ | ||||
| n | 31 | 6 | 5 | |
| Median (range), d | 43 (23-85) | 32.5 (28-51) | — | .12 |
| Acute GVHD | ||||
| Any | 17 | 3 | 2 | |
| Grade I | 6 | 2 | 1 | |
| Grade II | 6 | 1 | 1 | |
| Grade III | 2 | 0 | 0 | |
| Grade IV | 3 | 0 | 0 | |
| Not evaluated | 1 | 0 | 0 | |
| Chronic GVHD | ||||
| Any | 5 | 0 | 0 | |
| Limited | 5 | 0 | 0 | |
| Extensive | 0 | 0 | 0 | |
| Not evaluated | 3 | 0 | 0 | |
| Relapse | ||||
| Any | 10 | 2 | 1 | |
| BM relapse | 5 | 0 | 1 | |
| Combined BM/EM relapse | 4 | 1 | 0 | |
| Isolated EM relapse | 1 | 1 | 0 | |
| Nonrelapse death | 1 | 0 | 0 | |
| Continuous CR (%) | 22 (68.8) | 3 (50) | 4 (80) | |
| . | Protocol-specified HSCT . | Protocol-unspecified HSCT, n = 5 . | P* . | |
|---|---|---|---|---|
| UCBD, n = 32 . | MFD, n = 6 . | |||
| FCM-MRD at TP3 | ||||
| Negative | 22 | 6 | 3 | |
| Positive | 1 | 0 | 0 | |
| Not evaluated | 9 | 0 | 2 | |
| Days from registration to HSCT | ||||
| Median (range) | 156 (135-194) | 185 (138-196) | 163 (150-190) | .27 |
| Donor | ||||
| UCBD | 32 | — | 4 | |
| MFD | — | 6 (5 BM and 1 PBSC) | 0 | |
| Haploidentical mother | — | — | 1 | |
| Conditioning regimen | ||||
| BU + ETP + CY | 32 | 6 | 3 | |
| FLU + MEL + other | — | — | 2 | |
| GVHD prophylaxis | ||||
| TAC + sMTX | 22 | 4 | 5 | |
| CsA + sMTX | 10 | 1 | 0 | |
| MTX only | 0 | 1 | 0 | |
| Infused cell dose, ×107/kg | ||||
| Median (range) | 12.3 (0.113-115) | 41.5 (19.3-69.0) | — | .0077 |
| Neutrophil engraftment† | ||||
| n | 31 | 6 | 5 | |
| Median (range), d | 17 (12-39) | 15.5 (14-17) | — | .0024 |
| Platelet engraftment‡ | ||||
| n | 31 | 6 | 5 | |
| Median (range), d | 43 (23-85) | 32.5 (28-51) | — | .12 |
| Acute GVHD | ||||
| Any | 17 | 3 | 2 | |
| Grade I | 6 | 2 | 1 | |
| Grade II | 6 | 1 | 1 | |
| Grade III | 2 | 0 | 0 | |
| Grade IV | 3 | 0 | 0 | |
| Not evaluated | 1 | 0 | 0 | |
| Chronic GVHD | ||||
| Any | 5 | 0 | 0 | |
| Limited | 5 | 0 | 0 | |
| Extensive | 0 | 0 | 0 | |
| Not evaluated | 3 | 0 | 0 | |
| Relapse | ||||
| Any | 10 | 2 | 1 | |
| BM relapse | 5 | 0 | 1 | |
| Combined BM/EM relapse | 4 | 1 | 0 | |
| Isolated EM relapse | 1 | 1 | 0 | |
| Nonrelapse death | 1 | 0 | 0 | |
| Continuous CR (%) | 22 (68.8) | 3 (50) | 4 (80) | |
CsA, cyclosporine; EM, extramedullary; FLU, fludarabine; MEL, melphalan; MTX, methotrexate; sMTX, short-term methotrexate; TAC, tacrolimus; TP3, time point 3 (at the end of early consolidation).
Comparison between UCBD and MFD among the 38 patients who received protocol-specified HSCT.
Neutrophil engraftment, the first day of the 3 consecutive days achieving an absolute neutrophil count ≥0.5 × 109/L.
Platelet engraftment, the first day of achieving a platelet count ≥20 × 109/L without transfusions.