Clinical trials with CD19CAR T cell
Study . | N . | Median age (range), y . | Prior allo-HCT (%) . | Prelympho disease (<5%) in the absence of EMD (%) . | Prior blinatumomab (%) . | CNS . | EMD (%) . | CR/CRi% (MRD− %) . | Post-CAR allo-HCT in responders, % . | Relapse, % . | Survival . | CD19− relapse, % . | No. of pts who underwent leuk but no CAR T . | Ref. . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
U Penn/ CHOP | 30 | 14 (5-60) | 18 (60) | 6 (20) | 3 (10) | CNS-2 = 2 | NR | 90 (88) | 3 (11) | 7 (26) | 6-mo EFS = 67% | 3 (43) | NR | 22 |
6-mo OS = 78% | ||||||||||||||
MSKCC | 53 | 44 (23-74) | 19 (36) | 21 (48) | 13 (25) | None | 5 (9) | 83 (67) | 17 (39) | 25 (57) | Median EFS = 6.1 mo | 4 (16) | 24 | 14 |
Median OS = 12.9 mo | ||||||||||||||
Novartis multicenter | 75 | 11 (3-23) | 46 (61) | NR | NR | CNS-2 = 1 | NR | 81 (81) | 8 (13) | 22 (36) | 12-mo EFS = 50% | 15 (68) | 17 | 17 |
CNS-3 = 1 | 12-mo OS = 76% | |||||||||||||
NCI | 21 | 13 (1-30) | 8 (38) | 5 (24) | 0 (0) | CNS-2 = 2 | NR | 67 (86) | 10 (71) | 2 (14) | 5-mo LFS = 79% | 2 (100) | NR | 42 |
10-mo OS = 52% | ||||||||||||||
Seattle Children’s Hospital | 45 | 12 (1-25) | 28 (62) | 15 (33) | 6 (13) | CNS-2 = 7 | NR | 93 (100) | 11 (28) | 18 (45) | 12-mo EFS = 51% | 7 (39) | NR | 21 |
CNS-3 = 2 | 12-mo OS = 70% | |||||||||||||
FHCRC | 53 | 39 (20-76) | 23 (43) | 14 (26) | 10 (19) | CNS-2 = 5 | 18 (34) | 85 (85) | 18 (40) | 22 (49) | For responders, median EFS = 7.6 mo, and | 6 (27) | 2 | 41 |
median OS= 20 mo = | ||||||||||||||
Hebei Yanda Lu Daopei Hospital, China | 51 | 11 (3-68) and 24 (2-44)* | NR | 9 (18) | NR | 4 | 16 (31) | 90 (88) | 27 (60) | 11 (24) | Relapse = 60% vs 6% for responders who did and did not receive HCT (P = .023) | 6 (55) | NR | 27 |
COH | 13† | 33 (24-72) | 6 (46) | 5 (38) | 9 (69) | None | NR | 100 (91) | 8 (73) | NR | NR | NR | 3 | 37 |
CARPALL | 14 | 9 (1-19) | 10 (71) | 10 (79) | 1 (7) | CNS 2/3 = 2 | 86 (86) | 0 (0) | 6 (50) | 12-mo OS = 63% | 5 (83) | 3 | 36 | |
12-mo EFS = 46% |
Study . | N . | Median age (range), y . | Prior allo-HCT (%) . | Prelympho disease (<5%) in the absence of EMD (%) . | Prior blinatumomab (%) . | CNS . | EMD (%) . | CR/CRi% (MRD− %) . | Post-CAR allo-HCT in responders, % . | Relapse, % . | Survival . | CD19− relapse, % . | No. of pts who underwent leuk but no CAR T . | Ref. . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
U Penn/ CHOP | 30 | 14 (5-60) | 18 (60) | 6 (20) | 3 (10) | CNS-2 = 2 | NR | 90 (88) | 3 (11) | 7 (26) | 6-mo EFS = 67% | 3 (43) | NR | 22 |
6-mo OS = 78% | ||||||||||||||
MSKCC | 53 | 44 (23-74) | 19 (36) | 21 (48) | 13 (25) | None | 5 (9) | 83 (67) | 17 (39) | 25 (57) | Median EFS = 6.1 mo | 4 (16) | 24 | 14 |
Median OS = 12.9 mo | ||||||||||||||
Novartis multicenter | 75 | 11 (3-23) | 46 (61) | NR | NR | CNS-2 = 1 | NR | 81 (81) | 8 (13) | 22 (36) | 12-mo EFS = 50% | 15 (68) | 17 | 17 |
CNS-3 = 1 | 12-mo OS = 76% | |||||||||||||
NCI | 21 | 13 (1-30) | 8 (38) | 5 (24) | 0 (0) | CNS-2 = 2 | NR | 67 (86) | 10 (71) | 2 (14) | 5-mo LFS = 79% | 2 (100) | NR | 42 |
10-mo OS = 52% | ||||||||||||||
Seattle Children’s Hospital | 45 | 12 (1-25) | 28 (62) | 15 (33) | 6 (13) | CNS-2 = 7 | NR | 93 (100) | 11 (28) | 18 (45) | 12-mo EFS = 51% | 7 (39) | NR | 21 |
CNS-3 = 2 | 12-mo OS = 70% | |||||||||||||
FHCRC | 53 | 39 (20-76) | 23 (43) | 14 (26) | 10 (19) | CNS-2 = 5 | 18 (34) | 85 (85) | 18 (40) | 22 (49) | For responders, median EFS = 7.6 mo, and | 6 (27) | 2 | 41 |
median OS= 20 mo = | ||||||||||||||
Hebei Yanda Lu Daopei Hospital, China | 51 | 11 (3-68) and 24 (2-44)* | NR | 9 (18) | NR | 4 | 16 (31) | 90 (88) | 27 (60) | 11 (24) | Relapse = 60% vs 6% for responders who did and did not receive HCT (P = .023) | 6 (55) | NR | 27 |
COH | 13† | 33 (24-72) | 6 (46) | 5 (38) | 9 (69) | None | NR | 100 (91) | 8 (73) | NR | NR | NR | 3 | 37 |
CARPALL | 14 | 9 (1-19) | 10 (71) | 10 (79) | 1 (7) | CNS 2/3 = 2 | 86 (86) | 0 (0) | 6 (50) | 12-mo OS = 63% | 5 (83) | 3 | 36 | |
12-mo EFS = 46% |
CHOP, Children Hospital of Philadelphia; CNS-2, central nervous system-2 defined as <5 white blood cells (WBC)/μl of cerebrospinal fluid (CSF) with presence of lymphoblasts; CNS-3, ≥5 WBC/μl CSF with presence of lymphoblasts; LFS, leukemia-free survival; leuk, leukapharesis; NCI, National Cancer Institute; pts, patients; U Penn, University of Pennsylvania. See Table 1 for expansion of other abbreviations.
First median age and range for patients with r/r ALL; second median age and range for patients only treated for MRD+ disease.
Only 11 were evaluable for response as one received less than the intended dose and the other one had an EMD CD19− lesion.