Summary of patient baseline characteristics
| Parameter/statistic, n(%) . | Part 1 . | Part 2 . | Total (N = 52) . | ||||
|---|---|---|---|---|---|---|---|
| CHOP + pralatrexate 10 mg/m2 (n = 4) . | CHOP + pralatrexate 15 mg/m2 (n = 3) . | CHOP + pralatrexate 20 mg/m2 (n = 3) . | CHOP + pralatrexate 25 mg/m2 (n = 3) . | CHOP + pralatrexate 30 mg/m2 (n = 6) . | CHOP + pralatrexate 30 mg/m2 (n = 33) . | ||
| Age, median (range), y | 68.5 (55-74) | 60.0 (18-73) | 60.0 (53-72) | 47.0 (31-58) | 66.0 (43-76) | 62.0 (19-78) | 62.0 (18-78) |
| Age category, n (%), y | |||||||
| <65 | 1 (25.0) | 2 (66.7) | 2 (66.7) | 3 (100.0) | 2 (33.3) | 18 (54.5) | 28 (53.8) |
| 65-75 | 3 (75.0) | 1 (33.3) | 1 (33.3) | 0 | 3 (50.0) | 13 (39.4) | 21 (40.4) |
| >75 | 0 | 0 | 0 | 0 | 1 (16.7) | 2 (6.1) | 3 (5.8) |
| Sex, n (%) | |||||||
| Male | 4 (100.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 3 (50.0) | 18 (54.5) | 30 (57.7) |
| Female | 0 | 2 (66.7) | 1 (33.3) | 1 (33.3) | 3 (50.0) | 15 (45.5) | 22 (42.3) |
| Race, n (%) | |||||||
| White or Caucasian | 3 (75.0) | 3 (100.0) | 2 (66.7) | 3 (100.0) | 6 (100.0) | 24 (72.7) | 41 (78.8) |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 5 (15.2) | 5 (9.6) |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| Asian | 1 (25.0) | 0 | 1 (33.3) | 0 | 0 | 2 (6.1) | 4 (7.7) |
| Other | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 1 (25.0) | 1 (33.3) | 0 | 0 | 0 | 3 (9.1) | 5 (9.6) |
| Not Hispanic or Latino | 3 (75.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 30 (90.9) | 47 (90.4) |
| Subtype of PTCL, n (%) | |||||||
| ALCL, ALK negative | 1 (25.0) | 2 (66.7) | 0 | 0 | 0 | 4 (12.1) | 7 (13.5) |
| ALCL, ALK positive | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| AITL | 1 (25.0) | 0 | 1 (33.3) | 0 | 2 (33.3) | 5 (15.2) | 9 (17.3) |
| Hepatosplenic T-cell lymphoma | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| PTCL, NOS | 2 (50.0) | 1 (33.3) | 2 (66.7) | 3 (100) | 4 (66.7) | 22 (66.7) | 34 (65.4) |
| Eastern Cooperative Oncology Group performance status, n (%) | |||||||
| 0 (fully active) | 1 (25.0) | 2 (66.7) | 2 (66.7) | 3 (100.0) | 3 (50.0) | 19 (57.6) | 30 (57.7) |
| 1 (restricted in physically strenuous activity but ambulatory) | 2 (50.0) | 0 | 1 (33.3) | 0 | 2 (33.3) | 11 (33.3) | 16 (30.8) |
| 2 (ambulatory and capable of all self-care but unable to carry out work) | 0 | 1 (33.3) | 0 | 0 | 1 (16.7) | 3 (9.1) | 5 (9.6) |
| Bone marrow finding, n (%) | |||||||
| Lymphoma not present | 1 (25.0) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 3 (50.0) | 17 (51.5) | 25 (48.1) |
| Lymphoma present | 2 (50.0) | 0 | 1 (33.3) | 1 (33.3) | 3 (50.0) | 9 (27.3) | 16 (30.8) |
| Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Parameter/statistic, n(%) . | Part 1 . | Part 2 . | Total (N = 52) . | ||||
|---|---|---|---|---|---|---|---|
| CHOP + pralatrexate 10 mg/m2 (n = 4) . | CHOP + pralatrexate 15 mg/m2 (n = 3) . | CHOP + pralatrexate 20 mg/m2 (n = 3) . | CHOP + pralatrexate 25 mg/m2 (n = 3) . | CHOP + pralatrexate 30 mg/m2 (n = 6) . | CHOP + pralatrexate 30 mg/m2 (n = 33) . | ||
| Age, median (range), y | 68.5 (55-74) | 60.0 (18-73) | 60.0 (53-72) | 47.0 (31-58) | 66.0 (43-76) | 62.0 (19-78) | 62.0 (18-78) |
| Age category, n (%), y | |||||||
| <65 | 1 (25.0) | 2 (66.7) | 2 (66.7) | 3 (100.0) | 2 (33.3) | 18 (54.5) | 28 (53.8) |
| 65-75 | 3 (75.0) | 1 (33.3) | 1 (33.3) | 0 | 3 (50.0) | 13 (39.4) | 21 (40.4) |
| >75 | 0 | 0 | 0 | 0 | 1 (16.7) | 2 (6.1) | 3 (5.8) |
| Sex, n (%) | |||||||
| Male | 4 (100.0) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 3 (50.0) | 18 (54.5) | 30 (57.7) |
| Female | 0 | 2 (66.7) | 1 (33.3) | 1 (33.3) | 3 (50.0) | 15 (45.5) | 22 (42.3) |
| Race, n (%) | |||||||
| White or Caucasian | 3 (75.0) | 3 (100.0) | 2 (66.7) | 3 (100.0) | 6 (100.0) | 24 (72.7) | 41 (78.8) |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 5 (15.2) | 5 (9.6) |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| Asian | 1 (25.0) | 0 | 1 (33.3) | 0 | 0 | 2 (6.1) | 4 (7.7) |
| Other | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 1 (25.0) | 1 (33.3) | 0 | 0 | 0 | 3 (9.1) | 5 (9.6) |
| Not Hispanic or Latino | 3 (75.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 30 (90.9) | 47 (90.4) |
| Subtype of PTCL, n (%) | |||||||
| ALCL, ALK negative | 1 (25.0) | 2 (66.7) | 0 | 0 | 0 | 4 (12.1) | 7 (13.5) |
| ALCL, ALK positive | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| AITL | 1 (25.0) | 0 | 1 (33.3) | 0 | 2 (33.3) | 5 (15.2) | 9 (17.3) |
| Hepatosplenic T-cell lymphoma | 0 | 0 | 0 | 0 | 0 | 1 (3.0) | 1 (1.9) |
| PTCL, NOS | 2 (50.0) | 1 (33.3) | 2 (66.7) | 3 (100) | 4 (66.7) | 22 (66.7) | 34 (65.4) |
| Eastern Cooperative Oncology Group performance status, n (%) | |||||||
| 0 (fully active) | 1 (25.0) | 2 (66.7) | 2 (66.7) | 3 (100.0) | 3 (50.0) | 19 (57.6) | 30 (57.7) |
| 1 (restricted in physically strenuous activity but ambulatory) | 2 (50.0) | 0 | 1 (33.3) | 0 | 2 (33.3) | 11 (33.3) | 16 (30.8) |
| 2 (ambulatory and capable of all self-care but unable to carry out work) | 0 | 1 (33.3) | 0 | 0 | 1 (16.7) | 3 (9.1) | 5 (9.6) |
| Bone marrow finding, n (%) | |||||||
| Lymphoma not present | 1 (25.0) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 3 (50.0) | 17 (51.5) | 25 (48.1) |
| Lymphoma present | 2 (50.0) | 0 | 1 (33.3) | 1 (33.3) | 3 (50.0) | 9 (27.3) | 16 (30.8) |
| Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 | 0 |