Efficacy endpoints in infused subjects (n = 19)
UPN . | iwCLL . | Marrow response . | MRD∗ . | Last follow-up (mo) . | Status at last follow-up . | On Ibrutinib at last follow-up . | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
M3 . | M12 . | M3 . | M12 . | Preinfusion . | M1 . | M3 . | M6 . | M12 . | ||||
01 | CR | CR | CR | CR | 5.7 × 10−2 | 2.3 × 10−5 | 2.5 × 10−5 | 5.8 × 10−6 | 1.5 × 10−5 | 54 | CR | Y |
02 | PR | PR | CR | CR | 4.5 × 10−2† | 1.3 × 10−4 | 7.9 × 10−7 | ND | ND | 58 | Relapse | N |
03 | CR | PR | CR | CR | 5.4 × 10−2 | ND | ND | ND† | ND | 43 | CR | Y |
04 | NA | CR | CR | CR | 1.1 × 10−1 | 6.5 × 10−6 | ND | ND† | ND | 45 | CR | Y |
05 | CR | CR | CR | CR | 2.8 × 10−1 | ND | ND | ND† | ND | 55 | CR | N |
06 | PR | NA | CR | CR | 6.6 × 10−2 | ND | ND | ND | ND | 47 | CR | N |
07 | CR | PR | CR | CR | 2.0 × 10−1† | ND | ND | ND | ND | 48 | CR | N |
08 | SD | NA | CR | CR | 2.1 × 10−1 | ND | ND | ND† | ND | 49 | CR | N |
09 | PD | PD | CR | NR | 3.7 × 10−1 | 4.5 × 10−6 | ND | NA | 4.9 × 10−2 | 25 | Died‡ | N |
10 | SD | PR | CR | CR | 1.4 × 10−1 | 3.0 × 10−3 | 2.3 × 10−3 | 1.2 × 10−3 | 6.5 × 10−4 | 31 | Died§ | Y |
11 | CR | NA | CR | NA | 1.9 × 10−2 | ND | ND | ND† | ND | 17 | NA‖ | N |
12 | PR | PR | CR | CR | 1.8 × 10−1 | 5.9 × 10−5 | ND | ND† | 2.9 × 10−5 | 33 | CR | N |
13 | SD | NA | CR | CR | 7.4 × 10−2 | ND | ND | ND† | ND | 38 | CR | N |
15 | PR | CR | CR | CR | 2.7 × 10−1 | ND | ND | ND | ND | 45 | CR | N |
16 | NA | CR | CR | CR | 1.2 × 10−1† | ND | ND | ND† | ND | 41 | CR | Y |
17 | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.25 | Died¶ | NA |
18 | SD | SD | NR | NR | 9.7 × 10−2 | 3.1 × 10−2 | 3.2 × 10−2 | 9.2 × 10−2† | 6.8 × 10−2 | 41 | SD | N |
19 | CR | CR | CR | CR | 4.2 × 10−2 | ND | ND | ND | ND | 39 | CR | N |
20 | CR | CR | CR | CR | 2.0 × 10−1 | ND | ND | ND | ND | 40 | CR | N |
UPN . | iwCLL . | Marrow response . | MRD∗ . | Last follow-up (mo) . | Status at last follow-up . | On Ibrutinib at last follow-up . | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
M3 . | M12 . | M3 . | M12 . | Preinfusion . | M1 . | M3 . | M6 . | M12 . | ||||
01 | CR | CR | CR | CR | 5.7 × 10−2 | 2.3 × 10−5 | 2.5 × 10−5 | 5.8 × 10−6 | 1.5 × 10−5 | 54 | CR | Y |
02 | PR | PR | CR | CR | 4.5 × 10−2† | 1.3 × 10−4 | 7.9 × 10−7 | ND | ND | 58 | Relapse | N |
03 | CR | PR | CR | CR | 5.4 × 10−2 | ND | ND | ND† | ND | 43 | CR | Y |
04 | NA | CR | CR | CR | 1.1 × 10−1 | 6.5 × 10−6 | ND | ND† | ND | 45 | CR | Y |
05 | CR | CR | CR | CR | 2.8 × 10−1 | ND | ND | ND† | ND | 55 | CR | N |
06 | PR | NA | CR | CR | 6.6 × 10−2 | ND | ND | ND | ND | 47 | CR | N |
07 | CR | PR | CR | CR | 2.0 × 10−1† | ND | ND | ND | ND | 48 | CR | N |
08 | SD | NA | CR | CR | 2.1 × 10−1 | ND | ND | ND† | ND | 49 | CR | N |
09 | PD | PD | CR | NR | 3.7 × 10−1 | 4.5 × 10−6 | ND | NA | 4.9 × 10−2 | 25 | Died‡ | N |
10 | SD | PR | CR | CR | 1.4 × 10−1 | 3.0 × 10−3 | 2.3 × 10−3 | 1.2 × 10−3 | 6.5 × 10−4 | 31 | Died§ | Y |
11 | CR | NA | CR | NA | 1.9 × 10−2 | ND | ND | ND† | ND | 17 | NA‖ | N |
12 | PR | PR | CR | CR | 1.8 × 10−1 | 5.9 × 10−5 | ND | ND† | 2.9 × 10−5 | 33 | CR | N |
13 | SD | NA | CR | CR | 7.4 × 10−2 | ND | ND | ND† | ND | 38 | CR | N |
15 | PR | CR | CR | CR | 2.7 × 10−1 | ND | ND | ND | ND | 45 | CR | N |
16 | NA | CR | CR | CR | 1.2 × 10−1† | ND | ND | ND† | ND | 41 | CR | Y |
17 | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0.25 | Died¶ | NA |
18 | SD | SD | NR | NR | 9.7 × 10−2 | 3.1 × 10−2 | 3.2 × 10−2 | 9.2 × 10−2† | 6.8 × 10−2 | 41 | SD | N |
19 | CR | CR | CR | CR | 4.2 × 10−2 | ND | ND | ND | ND | 39 | CR | N |
20 | CR | CR | CR | CR | 2.0 × 10−1 | ND | ND | ND | ND | 40 | CR | N |
NA, not assessable; ND, not detected; NR, no response; PR, partial response; SD, stable disease.
By deep sequencing of the immunoglobulin heavy chain (estimated number of genomes).
indicates sample was collected from peripheral blood instead of bone marrow.
Died of relapsed CLL.
Died in CR of infectious complications.
Lost to follow-up due to chemotherapy for second malignancy, therefore CLL disease status not known.
Died of toxicity.