Table 1:
Characteristics all Entire Cohort, CD34-Selected TCD Cohort, and Unmodified Cohort
| CAR + HSCT Entire Cohort N=15 | CAR + CD34-Selected HSCT Cohort N=9 | CAR + Unmodified HSCT Cohort N=6 | p-value* | ||
|---|---|---|---|---|---|
| Median Age (range, years) | 13 (1–20) | 13 (1–20) | 12.5 (4–20) | 0.81 | |
| Median time from CAR T cell therapy to allo-HSCT (range, days) | 57 (30–135) | 46 (30–135) | 65 (55–95) | 0.09 | |
|
Lymphodepleting regimen pre-CAR T cell therapy Cyclophosphamide/Fludarabine Cyclophosphamide |
6 9 |
4 5 |
2 4 |
>0.99 | |
|
CRS grade
0 1 2 3 4 |
2 6 5 1 1 |
2 4 2 0 1 |
0 2 3 1 0 |
>0.99 (0/1/2 vs 3/4) |
|
|
ICANS grade
0 1 2 3 4 |
2 4 5 3 1 |
2 2 3 1 1 |
0 2 2 2 0 |
>0.99 (0/1/2 vs 3/4) |
|
|
Disease Status
CR1 CR2 CR3 CR4 |
6 5 3 1 |
5 2 2 0 |
1 3 1 1 |
0.29 (CR1 vs ≥CR2) |
|
|
Conditioning Regimen TBI-based 1500 cGy 1200–1440 cGy unknown Chemotherapy only clo/mel/thio** flu/mel/thio*** |
12 8 3 1 3 2 1 |
7 7 0 0 2 2 0 |
5 1 3 1 1 0 1 |
>0.99 | |
|
HLA Matched Mismatched Related Unrelated |
10 5 8 7 |
6 3 4 5 |
4 2 4 2 |
>0.99 0.61 |
|
|
Graft Source BM PBSC |
7 8 |
1 8 |
6 0 |
n/a | |
|
GVHD prophylaxis
CD34+ selected CNI plus MTX CNI plus MMF Post HSCT Cyclophosphamide |
9 4 1 1 |
9 0 0 0 |
0 4 1 1 |
n/a |
CAR, chimeric antigen receptor; HSCT, hematopoietic stem cell transplantation; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; CR, complete remission; TBI, total body irradiation; BM, bone marrow; PBSC, peripheral blood stem cell; GVHD, graft-vs-host disease; CNI, calcineurin inhibitor; MTX, methotrexate; n/a, not applicable for statistical analysis because graft source and GVHD prophylaxis is dependent on the graft manipulation cohort.
p-values from Mann-Whitney-Wilcoxon rank test or Fisher’s exact test.
clofarabine (150 mg/m2), melphalan (140 mg/m2), and thiotepa (10mg/kg).
fludarabine (120 mg/m2), melphalan (140 mg/m2), and thiotepa (10 mg/kg).