Baseline clinical characteristics and attributes of stem cell boost and subsequent engraftment
| . | Demographics and baseline patient characteristics . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| # . | Age . | Sex . | Pathology . | CAR product . | ECOG . | IPI . | Prior lines . | Prior autologous/ allogeneic SCT . | Bridging therapy . | BM infiltration . | LDH (U/L) . | HT score . |
| 1 | 44 | F | DLBCL, NOS | Axi-cel | 1 | 3 | 4 | Haploidentical SCT, 2 y prior | R-Benda, R-GEMOX | N | 451 | 4 |
| 2 | 61 | M | HGBL (DH) | Tisa-cel | 1 | 4 | 2 | — | R-ICE | N | 1431 | 6 |
| 3 | 59 | M | DLBCL, non-GCB (trFL) | Axi-cel | 1 | 1 | 4 | — | 2 x R-CHOP | Y (5% to 10%) | 237 | 7 |
| 4 | 36 | F | BCP-ALL | Axi-cel | 0 | N/A | 4 | Peripheral blood SCT from MUD (10/10), 1 y prior | Vincristine + dexamethasone | Y (80%) | 333 | 7 |
| 5 | 53 | M | DLBCL | Axi-cel | 2 | 2 | 4 | Autologous SCT | R-ICE + venetoclax | N | 145 | ≥3* |
| 6 | 65 | F | DLBCL (trFL) | Axi-cel | 1 | 2 | 4 | Autologous SCT | R-Benda | Y | 148 | ≥4* |
| 7 | 58 | M | DLBCL | Axi-cel | 1 | 2 | 3 | — | R-ICE | N | 497 | ≥4* |
| 8 | 71 | F | MCL | Brexu-cel | 1 | MIPI: int risk | 6 | Autologous SCT | R-Bortezomib | N | 331 | ≥4* |
| 9 | 67 | M | DLBCL | Axi-cel | 0 | 1 | 2 | — | R-ICE | N | 187 | ≥4* |
| 10 | 52 | F | DLBCL | Axi-cel | 0 | 2 | 2 | — | R-DHAC | N | 320 | 2 |
| 11 | 55 | F | DLBCL (trFL) | Axi-cel | 2 | 2 | 2 | — | R-DHAOx | N | 698 | 3 |
| 12 | 23 | M | BCP-ALL | Tisa-cel | 2 | N/A | 8 | Allogeneic SCT, 1 + 4 y prior | None | Y (90%) | 965 | 5 |
| Total (median, range) | 57 (36-71) | M/F 6:12 | 9 LBCL, 2 ALL, 1 MCL | 10/12 CD28z | 1 (0-2) | 2 (1-4) | 4 (2-8) | AlloSCT: 3/12 (25%), AutoSCT: 3/12 (25%) | Bridging: 11/12 (92%) | 4/12 (33%) | 332 (145-1431) | 4 (2-7) |
| . | Demographics and baseline patient characteristics . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| # . | Age . | Sex . | Pathology . | CAR product . | ECOG . | IPI . | Prior lines . | Prior autologous/ allogeneic SCT . | Bridging therapy . | BM infiltration . | LDH (U/L) . | HT score . |
| 1 | 44 | F | DLBCL, NOS | Axi-cel | 1 | 3 | 4 | Haploidentical SCT, 2 y prior | R-Benda, R-GEMOX | N | 451 | 4 |
| 2 | 61 | M | HGBL (DH) | Tisa-cel | 1 | 4 | 2 | — | R-ICE | N | 1431 | 6 |
| 3 | 59 | M | DLBCL, non-GCB (trFL) | Axi-cel | 1 | 1 | 4 | — | 2 x R-CHOP | Y (5% to 10%) | 237 | 7 |
| 4 | 36 | F | BCP-ALL | Axi-cel | 0 | N/A | 4 | Peripheral blood SCT from MUD (10/10), 1 y prior | Vincristine + dexamethasone | Y (80%) | 333 | 7 |
| 5 | 53 | M | DLBCL | Axi-cel | 2 | 2 | 4 | Autologous SCT | R-ICE + venetoclax | N | 145 | ≥3* |
| 6 | 65 | F | DLBCL (trFL) | Axi-cel | 1 | 2 | 4 | Autologous SCT | R-Benda | Y | 148 | ≥4* |
| 7 | 58 | M | DLBCL | Axi-cel | 1 | 2 | 3 | — | R-ICE | N | 497 | ≥4* |
| 8 | 71 | F | MCL | Brexu-cel | 1 | MIPI: int risk | 6 | Autologous SCT | R-Bortezomib | N | 331 | ≥4* |
| 9 | 67 | M | DLBCL | Axi-cel | 0 | 1 | 2 | — | R-ICE | N | 187 | ≥4* |
| 10 | 52 | F | DLBCL | Axi-cel | 0 | 2 | 2 | — | R-DHAC | N | 320 | 2 |
| 11 | 55 | F | DLBCL (trFL) | Axi-cel | 2 | 2 | 2 | — | R-DHAOx | N | 698 | 3 |
| 12 | 23 | M | BCP-ALL | Tisa-cel | 2 | N/A | 8 | Allogeneic SCT, 1 + 4 y prior | None | Y (90%) | 965 | 5 |
| Total (median, range) | 57 (36-71) | M/F 6:12 | 9 LBCL, 2 ALL, 1 MCL | 10/12 CD28z | 1 (0-2) | 2 (1-4) | 4 (2-8) | AlloSCT: 3/12 (25%), AutoSCT: 3/12 (25%) | Bridging: 11/12 (92%) | 4/12 (33%) | 332 (145-1431) | 4 (2-7) |
| . | Stem cell boost . | Neutrophil engraftment after boost . | Platelet engraftment after boost . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| # . | Day after CAR-T . | Indication for stem cell boost . | Stem cell source . | CD34+ selection . | Total no. of infused cells (×106 CD34/kg) . | ANC (G/L) on day of boost . | Day of engraftment (n = 11) . | PLT count (G/L) on day of boost . | Day of engraftment (n = 9) . |
| 1 | 343 | Persistent neutropenia* | Allo | — | 7.5 | 0.8 | 15 | 73 | — |
| 2 | 35 | Pancytopenia | Auto | — | 3.6 | 0 | 9 | 33 | 12 |
| 3 | 41 | Pancytopenia | Auto | Yes | 3.1 | 0 | 12 | 12 | Death prior to engraftment |
| 4 | 146 | Pancytopenia | Allo | Yes | 3.0 | 0.2 | 6 | 21 | 16 |
| 5 | 55 | Persistent cytopenia*/† | Auto | — | 4.6 | 0.6 | 29 | 7 | 29 |
| 6 | 212/617 | Persistent neutropenia* | Auto | — | 2.1/2.2 | 0.5 | 124 | 133 | — |
| 7 | 46/93 | Pancytopenia | Auto | — | 3.0/3.0 | 0.04 | 14 | 2 | 34 (2nd boost for pers. thrombocytopenia) |
| 8 | 84 | Persistent thrombocytopenia† | Auto | — | 4.9 | 7.9 | — | 34 | Progression prior to engraftment |
| 9 | 370 | Persistent neutropenia* | Auto | — | 1.7 | 0.9 | 14 | 85 | — |
| 10 | 48 | Pancytopenia | Auto | Yes | 2.6 | 0 | 16 | 11 | 31 |
| 11 | 399 | Persistent cytopenia*/† | Auto | Yes | 6.0 | 1.1 | 8 | 33 | 21 |
| 12 | 42 | Pancytopenia | Allo | Yes | 5.5 | 0.6 | 21 | 7 | 14 |
| Median (Range) | 69 (35-617) | Pancytopenia: 6/12, persistent cytopenia: 6/12 | 9 autoSCT, 3 alloSCT | 5/12 (42%) | 3.1 (1.7-7.5) | 0.50 (0-7.9) | Engraftment: 11/11 (100%), Day: 15 (6-124) | 27 (2-133) | Engraftment: 7/9 (78%), Day: 21 (12-34) |
| . | Stem cell boost . | Neutrophil engraftment after boost . | Platelet engraftment after boost . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| # . | Day after CAR-T . | Indication for stem cell boost . | Stem cell source . | CD34+ selection . | Total no. of infused cells (×106 CD34/kg) . | ANC (G/L) on day of boost . | Day of engraftment (n = 11) . | PLT count (G/L) on day of boost . | Day of engraftment (n = 9) . |
| 1 | 343 | Persistent neutropenia* | Allo | — | 7.5 | 0.8 | 15 | 73 | — |
| 2 | 35 | Pancytopenia | Auto | — | 3.6 | 0 | 9 | 33 | 12 |
| 3 | 41 | Pancytopenia | Auto | Yes | 3.1 | 0 | 12 | 12 | Death prior to engraftment |
| 4 | 146 | Pancytopenia | Allo | Yes | 3.0 | 0.2 | 6 | 21 | 16 |
| 5 | 55 | Persistent cytopenia*/† | Auto | — | 4.6 | 0.6 | 29 | 7 | 29 |
| 6 | 212/617 | Persistent neutropenia* | Auto | — | 2.1/2.2 | 0.5 | 124 | 133 | — |
| 7 | 46/93 | Pancytopenia | Auto | — | 3.0/3.0 | 0.04 | 14 | 2 | 34 (2nd boost for pers. thrombocytopenia) |
| 8 | 84 | Persistent thrombocytopenia† | Auto | — | 4.9 | 7.9 | — | 34 | Progression prior to engraftment |
| 9 | 370 | Persistent neutropenia* | Auto | — | 1.7 | 0.9 | 14 | 85 | — |
| 10 | 48 | Pancytopenia | Auto | Yes | 2.6 | 0 | 16 | 11 | 31 |
| 11 | 399 | Persistent cytopenia*/† | Auto | Yes | 6.0 | 1.1 | 8 | 33 | 21 |
| 12 | 42 | Pancytopenia | Allo | Yes | 5.5 | 0.6 | 21 | 7 | 14 |
| Median (Range) | 69 (35-617) | Pancytopenia: 6/12, persistent cytopenia: 6/12 | 9 autoSCT, 3 alloSCT | 5/12 (42%) | 3.1 (1.7-7.5) | 0.50 (0-7.9) | Engraftment: 11/11 (100%), Day: 15 (6-124) | 27 (2-133) | Engraftment: 7/9 (78%), Day: 21 (12-34) |
Characteristics are provided for all included patients (n = 12). Bridging therapy was defined as antineoplastic therapy administered between CAR-T indication and infusion. Prior to stem cell boost, 3 patients (#1, 7, 10) fulfilled platelet engraftment criteria and 1 patient fulfilled criteria for neutrophil engraftment (#9). These patients were excluded from the calculation of median time to engraftment.
Axi-cel, Axicabtagene ciloleucel; Brexu-cel, Brexucabtagene autoleucel; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group Performance Status; HGBL, high-grade B-cell lymphoma; HT score, CAR-HEMATOTOX score10 ; IPI, international prognostic index; LDH, lactate dehydrogenase; MCL, mantle cell lymphoma; MUD, matched unrelated donor transplantation; Tisa-cel, Tisagenlecleucel; trFL, transformed follicular lymphoma;
Indication for stem cell boost was long-lasting G-CSF dependency.
Indication for stem cell boost was ongoing platelet transfusion dependency. Patient 7 received a second boost for persistent thrombocytopenia.