Patient demographics and baseline disease characteristics
| . | Cohort 1 (ENKTL) (n = 22) . | Cohort 2 (PTCLs) (n = 44) . | Cohort 3 (MF and SS) (n = 11) . | Total (N = 77) . |
|---|---|---|---|---|
| Age, y | ||||
| Median | 47.5 | 58.0 | 62.0 | 56.0 |
| Min, max | 24, 76 | 21, 84 | 35, 76 | 21, 84 |
| Age group | ||||
| <60 y | 13 (59.1) | 24 (54.5) | 5 (45.5) | 42 (54.5) |
| ≥60 y | 9 (40.9) | 20 (45.5) | 6 (54.5) | 35 (45.5) |
| Sex | ||||
| Male | 14 (63.6) | 29 (65.9) | 8 (72.7) | 51 (66.2) |
| Female | 8 (36.4) | 15 (34.1) | 3 (27.3) | 26 (33.8) |
| Race | ||||
| Asian | 19 (86.4) | 23 (52.3) | 2 (18.2) | 44 (57.1) |
| White | 2 (9.1) | 18 (40.9) | 8 (72.7) | 28 (36.4) |
| Not reported | 1 (4.5) | 3 (6.8) | 1 (9.1) | 5 (6.5) |
| ECOG performance status at baseline | ||||
| 0 | 3 (13.6) | 21 (47.7) | 6 (54.5) | 30 (39.0) |
| 1 | 17 (77.3) | 21 (47.7) | 4 (36.4) | 42 (54.5) |
| 2 | 2 (9.1) | 2 (4.5) | 1 (9.1) | 5 (6.5) |
| Disease status | ||||
| Relapsed disease | 12 (54.5) | 21 (47.7) | 4 (36.4) | 37 (48.1) |
| Refractory disease | 10 (45.5) | 23 (52.3) | 7 (63.6) | 40 (51.9) |
| Advanced-stage disease∗,† | 14 (63.6) | 36 (81.8) | 9 (81.8) | 59 (76.6) |
| Bone marrow involvement† | 2 (9.1) | 9 (20.5) | 3 (27.3) | 14 (18.2) |
| B-symptoms† | 6 (27.3) | 11 (25.0) | 1 (9.1) | 18 (23.4) |
| High LDH at baseline‡ | 13 (59.1) | 16 (36.4) | 3 (27.3) | 32 (41.6) |
| Low lymphocyte count at baseline†,‡ | 9 (40.9) | 23 (52.3) | 3 (27.3) | 35 (45.5) |
| Number of prior regimens | ||||
| Median | 2.0 | 2.0 | 4.0 | 2.0 |
| Min, max | 1, 5 | 1, 8 | 2, 6 | 1, 8 |
| Number of prior regimens | ||||
| <3 | 13 (59.1) | 24 (54.5) | 2 (18.2) | 39 (50.6) |
| ≥3 | 9 (40.9) | 20 (45.5) | 9 (81.8) | 38 (49.4) |
| Prior autologous stem cell transplant | 0 (0.0) | 6 (13.6) | 0 (0.0) | 6 (7.8) |
| Prior allogenic stem cell transplant§ | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Prior radiation therapy | 16 (72.7) | 8 (18.2) | 4 (36.4) | 28 (36.4) |
| . | Cohort 1 (ENKTL) (n = 22) . | Cohort 2 (PTCLs) (n = 44) . | Cohort 3 (MF and SS) (n = 11) . | Total (N = 77) . |
|---|---|---|---|---|
| Age, y | ||||
| Median | 47.5 | 58.0 | 62.0 | 56.0 |
| Min, max | 24, 76 | 21, 84 | 35, 76 | 21, 84 |
| Age group | ||||
| <60 y | 13 (59.1) | 24 (54.5) | 5 (45.5) | 42 (54.5) |
| ≥60 y | 9 (40.9) | 20 (45.5) | 6 (54.5) | 35 (45.5) |
| Sex | ||||
| Male | 14 (63.6) | 29 (65.9) | 8 (72.7) | 51 (66.2) |
| Female | 8 (36.4) | 15 (34.1) | 3 (27.3) | 26 (33.8) |
| Race | ||||
| Asian | 19 (86.4) | 23 (52.3) | 2 (18.2) | 44 (57.1) |
| White | 2 (9.1) | 18 (40.9) | 8 (72.7) | 28 (36.4) |
| Not reported | 1 (4.5) | 3 (6.8) | 1 (9.1) | 5 (6.5) |
| ECOG performance status at baseline | ||||
| 0 | 3 (13.6) | 21 (47.7) | 6 (54.5) | 30 (39.0) |
| 1 | 17 (77.3) | 21 (47.7) | 4 (36.4) | 42 (54.5) |
| 2 | 2 (9.1) | 2 (4.5) | 1 (9.1) | 5 (6.5) |
| Disease status | ||||
| Relapsed disease | 12 (54.5) | 21 (47.7) | 4 (36.4) | 37 (48.1) |
| Refractory disease | 10 (45.5) | 23 (52.3) | 7 (63.6) | 40 (51.9) |
| Advanced-stage disease∗,† | 14 (63.6) | 36 (81.8) | 9 (81.8) | 59 (76.6) |
| Bone marrow involvement† | 2 (9.1) | 9 (20.5) | 3 (27.3) | 14 (18.2) |
| B-symptoms† | 6 (27.3) | 11 (25.0) | 1 (9.1) | 18 (23.4) |
| High LDH at baseline‡ | 13 (59.1) | 16 (36.4) | 3 (27.3) | 32 (41.6) |
| Low lymphocyte count at baseline†,‡ | 9 (40.9) | 23 (52.3) | 3 (27.3) | 35 (45.5) |
| Number of prior regimens | ||||
| Median | 2.0 | 2.0 | 4.0 | 2.0 |
| Min, max | 1, 5 | 1, 8 | 2, 6 | 1, 8 |
| Number of prior regimens | ||||
| <3 | 13 (59.1) | 24 (54.5) | 2 (18.2) | 39 (50.6) |
| ≥3 | 9 (40.9) | 20 (45.5) | 9 (81.8) | 38 (49.4) |
| Prior autologous stem cell transplant | 0 (0.0) | 6 (13.6) | 0 (0.0) | 6 (7.8) |
| Prior allogenic stem cell transplant§ | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Prior radiation therapy | 16 (72.7) | 8 (18.2) | 4 (36.4) | 28 (36.4) |
Data are expressed as number of patients (%), unless otherwise stated.
Cohort 1: patients with R/R ENKTL; cohort 2: patients with R/R PRCL-NOS, R/R AITL, or R/R ALCL; and cohort 3: patients with R/R MF or R/R SS.
ECOG, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; Max, maximum; Min, minimum.
Stages III to IV for cohort 1 and 2; stage IIB or higher for cohort 3.
Disease stage at study entry was missing for 1 patient in cohort 1. Bone marrow involvement at study entry was unknown for 3 patients in cohort 2 and 2 patients in cohort 3. B-symptom data at study entry was missing for 1 patient in cohort 2 and 2 patients in cohort 3. Lymphocytes count at study entry was missing for 1 patient in cohort 2.
Higher/lower than normal range.
One patient with prior allogenic stem cell transplant was enrolled as a protocol deviation. The deviation was considered unlikely to have had a substantive impact on the outcomes or conclusions of this study.