Demographic and baseline clinical characteristics of CTCL patients
| . | Mogamulizumab dose . | . | ||
|---|---|---|---|---|
| . | 0.1 mg/kg (n = 3) . | 0.3 mg/kg (n = 3) . | 1.0 mg/kg (n = 35)* . | Total (n = 41) . |
| Age, y, median (min, max) | 68 (62, 68) | 74 (64, 79) | 66 (35, 85) | 66 (35, 85) |
| Gender | ||||
| Male | 3 (100) | 1 (33.3) | 20 (57.1) | 24 (58.5) |
| Female | 0 (0) | 2 (67.7) | 15 (42.9) | 17 (41.5) |
| Race | ||||
| White/Caucasian | 1 (33.3) | 3 (100) | 32 (91.4) | 36 (87.8) |
| Black/African American | 1 (33.3) | 0 (0) | 2 (5.7) | 3 (7.3) |
| Other | 1 (33.3) | 0 (0) | 0 (0) | 1 (2.4) |
| Not reported | 0 | 0 (0) | 1 (2.9) | 1 (2.4) |
| Primary diagnosis | ||||
| Mycosis fungoides | 2 (67.7) | 2 (67.7) | 18 (51.4) | 22 (53.7) |
| Sézary syndrome | 1 (33.3) | 1 (33.3) | 17 (48.6) | 19 (46.3) |
| Clinical stage | ||||
| IB | 0 (0) | 0 (0) | 3 (8.6) | 3 (7.3) |
| II | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IIB | 0 (0) | 1 (33.3) | 8 (22.9) | 9 (22.0) |
| III | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IIIA | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IVA | 3 (33.3) | 2 (66.7) | 17 (48.6) | 22 (53.7) |
| IVB | 0 (0) | 0 (0) | 4 (11.4) | 4 (9.8) |
| ECOG performance status | ||||
| 0 | 2 (67.7) | 3 (100) | 26 (74.3) | 31 (75.6) |
| 1 | 0 (0) | 0 (0) | 9 (25.7) | 9 (21.9) |
| 2 | 1 (33.3) | 0 (0) | 0 (0) | 1 (2.4) |
| No. of prior systemic therapies, median (min, max) | 3 (1, 17) | |||
| Previous systemic therapies† | ||||
| Retinoids | 28 (68.3) | |||
| Interferon | 19 (46.3) | |||
| Chemotherapy | 24 (58.5) | |||
| Denileukin diftitox | 12 (29.3) | |||
| HDAC inhibitor | 13 (31.7) | |||
| Extracorporeal photopheresis | 19 (46.3) | |||
| Systemic steroids | 5 (12.2) | |||
| Investigational therapies | 18 (43.9) | |||
| Other (Revlimid, alemtuzumab, Velcade, etc.) | 8 (19.5) | |||
| . | Mogamulizumab dose . | . | ||
|---|---|---|---|---|
| . | 0.1 mg/kg (n = 3) . | 0.3 mg/kg (n = 3) . | 1.0 mg/kg (n = 35)* . | Total (n = 41) . |
| Age, y, median (min, max) | 68 (62, 68) | 74 (64, 79) | 66 (35, 85) | 66 (35, 85) |
| Gender | ||||
| Male | 3 (100) | 1 (33.3) | 20 (57.1) | 24 (58.5) |
| Female | 0 (0) | 2 (67.7) | 15 (42.9) | 17 (41.5) |
| Race | ||||
| White/Caucasian | 1 (33.3) | 3 (100) | 32 (91.4) | 36 (87.8) |
| Black/African American | 1 (33.3) | 0 (0) | 2 (5.7) | 3 (7.3) |
| Other | 1 (33.3) | 0 (0) | 0 (0) | 1 (2.4) |
| Not reported | 0 | 0 (0) | 1 (2.9) | 1 (2.4) |
| Primary diagnosis | ||||
| Mycosis fungoides | 2 (67.7) | 2 (67.7) | 18 (51.4) | 22 (53.7) |
| Sézary syndrome | 1 (33.3) | 1 (33.3) | 17 (48.6) | 19 (46.3) |
| Clinical stage | ||||
| IB | 0 (0) | 0 (0) | 3 (8.6) | 3 (7.3) |
| II | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IIB | 0 (0) | 1 (33.3) | 8 (22.9) | 9 (22.0) |
| III | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IIIA | 0 (0) | 0 (0) | 1 (2.9) | 1 (2.4) |
| IVA | 3 (33.3) | 2 (66.7) | 17 (48.6) | 22 (53.7) |
| IVB | 0 (0) | 0 (0) | 4 (11.4) | 4 (9.8) |
| ECOG performance status | ||||
| 0 | 2 (67.7) | 3 (100) | 26 (74.3) | 31 (75.6) |
| 1 | 0 (0) | 0 (0) | 9 (25.7) | 9 (21.9) |
| 2 | 1 (33.3) | 0 (0) | 0 (0) | 1 (2.4) |
| No. of prior systemic therapies, median (min, max) | 3 (1, 17) | |||
| Previous systemic therapies† | ||||
| Retinoids | 28 (68.3) | |||
| Interferon | 19 (46.3) | |||
| Chemotherapy | 24 (58.5) | |||
| Denileukin diftitox | 12 (29.3) | |||
| HDAC inhibitor | 13 (31.7) | |||
| Extracorporeal photopheresis | 19 (46.3) | |||
| Systemic steroids | 5 (12.2) | |||
| Investigational therapies | 18 (43.9) | |||
| Other (Revlimid, alemtuzumab, Velcade, etc.) | 8 (19.5) | |||
Values are n (%); summation of percentages does not always equal 100% because of rounding.
ECOG, Eastern Cooperative Oncology Group; HDAC, histone deacetylase; max, maximum; min, minimum.
Includes patients from phase 1 (n = 3) and phase 2 (n = 32).
If a subject received the same category of therapy multiple times (eg, if subject received methotrexate; cyclophosphamide, hydroxydaunorubicin, Oncovin, and prednisone; and gemcitabine, 3 different chemotherapy regimens), the subject was only counted as having prior chemotherapy once (counts are by subject, not by treatment).