Characterization of CR patients in remission at end of study (n = 16) by transplant status
| Characteristics . | CR patients in remission at EOS (n = 16) . | All other CR (n = 22) . | |
|---|---|---|---|
| SCT (n = 8) . | No SCT (n = 8) . | ||
| Median age in years (range) | 48.5 (17-61) | 59.5 (14-76) | 50.0 (17-74) |
| Female, n (%) | 4 (50) | 0 | 13 (59) |
| ECOG performance status, n (%) | |||
| Grade 0 | 2 (25) | 2 (25) | 11 (50) |
| Grade 1 | 6 (75) | 6 (75) | 11 (50) |
| ALK status, n (%) | |||
| Positive | 4 (50) | 1 (13) | 5 (23) |
| Negative | 4 (50) | 7 (88) | 17 (77) |
| Disease status relative to most recent prior therapy, n (%)* | |||
| Relapsed | 5 (63) | 6 (75) | 11 (50) |
| Refractory | 3 (38) | 2 (25) | 11 (50) |
| Primary refractory disease, n (%)† | 4 (50) | 3 (38) | 16 (73) |
| Stage at initial diagnosis, n (%) | |||
| I/II | 3 (38) | 2 (25) | 12 (55) |
| III/IV | 4 (51) | 2 (25) | 10 (46) |
| Unknown | 1 (13) | 4 (50) | 0 |
| Median time in months from initial diagnosis to first dose (range) | 21.7 (6.2-103.5) | 21.83 (7.2-113.2) | 19.55 (186.5) |
| Median time in months from most recent relapse to first dose (range)‡ | 1.2 (0.5-2.5) | 1.6 (0.4-2.9) | 2.1 (0.7-2.8) |
| Baseline B symptoms, n (%)§ | 4 (50) | 1 (13) | 6 (27) |
| Fever | 3 (38) | 0 | 3 (14) |
| Night sweats | 2 (25) | 1 (13) | 5 (23) |
| Median baseline SPD of dominant nodes or nodal masses per investigator (cm2, range)|| | 15.7 (4.5-76.8) | 12.1 (3.2, 47.8) | 11.9 (2.0, 51.3) |
| Baseline bone marrow involvement, n (%) | 0 | 0 | 2 (9) |
| Characteristics . | CR patients in remission at EOS (n = 16) . | All other CR (n = 22) . | |
|---|---|---|---|
| SCT (n = 8) . | No SCT (n = 8) . | ||
| Median age in years (range) | 48.5 (17-61) | 59.5 (14-76) | 50.0 (17-74) |
| Female, n (%) | 4 (50) | 0 | 13 (59) |
| ECOG performance status, n (%) | |||
| Grade 0 | 2 (25) | 2 (25) | 11 (50) |
| Grade 1 | 6 (75) | 6 (75) | 11 (50) |
| ALK status, n (%) | |||
| Positive | 4 (50) | 1 (13) | 5 (23) |
| Negative | 4 (50) | 7 (88) | 17 (77) |
| Disease status relative to most recent prior therapy, n (%)* | |||
| Relapsed | 5 (63) | 6 (75) | 11 (50) |
| Refractory | 3 (38) | 2 (25) | 11 (50) |
| Primary refractory disease, n (%)† | 4 (50) | 3 (38) | 16 (73) |
| Stage at initial diagnosis, n (%) | |||
| I/II | 3 (38) | 2 (25) | 12 (55) |
| III/IV | 4 (51) | 2 (25) | 10 (46) |
| Unknown | 1 (13) | 4 (50) | 0 |
| Median time in months from initial diagnosis to first dose (range) | 21.7 (6.2-103.5) | 21.83 (7.2-113.2) | 19.55 (186.5) |
| Median time in months from most recent relapse to first dose (range)‡ | 1.2 (0.5-2.5) | 1.6 (0.4-2.9) | 2.1 (0.7-2.8) |
| Baseline B symptoms, n (%)§ | 4 (50) | 1 (13) | 6 (27) |
| Fever | 3 (38) | 0 | 3 (14) |
| Night sweats | 2 (25) | 1 (13) | 5 (23) |
| Median baseline SPD of dominant nodes or nodal masses per investigator (cm2, range)|| | 15.7 (4.5-76.8) | 12.1 (3.2, 47.8) | 11.9 (2.0, 51.3) |
| Baseline bone marrow involvement, n (%) | 0 | 0 | 2 (9) |
The categories of CR in remission at end of study include patients with a best response of CR without new treatment and free of known PD per investigator or death due to disease.
Relapse = best response of CR if a patient only had 1 prior therapy, or best response of CR or PR to most recent prior therapy if a patient had more than 1 prior therapy; refractory = best response of PR, SD, or PD if a patient had only 1 prior therapy, or best response of SD or PD to most recent prior therapy if a patient had more than 1 prior therapy.
No CR, or relapse within 3 months of frontline therapy.
For those with relapsed disease status to most recent prior therapy.
B symptoms present at the time of cycle 1, day 1.
SPD of up to 6 of the largest dominant nodes or nodal masses.