Table 1. Baseline Characteristics of Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma in a Phase I Trial of Puquitinib Mesylate (XC-302, an inhibitor of phosphatidylinositol 3-kinase p110δ).
| Characteristic | XC-302 dosage | |||
|---|---|---|---|---|
| 25 mg, BID n = 3 | 37.5 mg, BID n = 9 | 50 mg, BID n = 9 | All n = 21 | |
| Age, median (range), y | 54 (43–58) | 49 (39–72) | 58 (42–68) | 56 (39–72) |
| Sex, n (%) | ||||
| Men | 2 (66.7) | 7 (77.8) | 8 (88.9) | 17 (81.0) |
| Women | 1 (33.3) | 2 (22.2) | 1 (11.1) | 4 (33.3) |
| ECOG performance status, n (%) | ||||
| 0 | 0 | 0 | 0 | 0 |
| 1 | 3 (100) | 9 (100) | 9 (100) | 21 (100) |
| Disease type, n (%) | ||||
| Follicular lymphoma | 1 (33.3) | 1 (11.1) | 1 (11.1) | 3 (14.3) |
| SLL/CLL | 0 | 1 (11.1) | 5 (55.6) | 10 (47.6) |
| Mantle cell lymphoma | 2 (66.7) | 5 (55.6) | 2 (22.2) | 5 (23.8) |
| Peripheral T-cell lymphoma | 0 | 1 (11.1) | 0 | 1 (4.8) |
| BPDCN | 0 | 1 (11.1) | 0 | 1 (4.8) |
| Gastric MALT | 0 | 0 | 1 (11.1) | 1 (4.8) |
| Bulky disease (≥1 lymph node ≥5 cm), n (%) | 1 (33.3) | 4 (44.4) | 2 (22.2) | 7 (33.3) |
| Elevated lactate dehydrogenase, n (%) | 0 | 4 (44.4) | 3 (33.3) | 7 (33.3) |
| Anemia, n (%) | 0 | 1 (11.1) | 3 (33.3) | 4 (33.3) |
| Thrombocytopenia, n (%) | 1 (33.3) | 5 (55.6) | 3 (33.3) | 9 (42.9) |
| Neutropenia, n (%) | 1 (33.3) | 2 (22.2) | 3 (33.3) | 6 (28.6) |
| Elevated ALT/AST, n (%) | 1 (33.3) | 2 (22.2) | 0 | 3 (14.3) |
| Clinical stage, n (%) | ||||
| III | 0 | 1 (11.1) | 4 (44.4) | 5 (23.8) |
| IV | 3 (100) | 8 (88.9) | 5 (55.6) | 16 (76.2) |
| LBMI, n (%) | 3 (100) | 6 (66.7) | 4 (44.4) | 13 (61.9) |
| Time since diagnosis, median (range), months | 38.1(1.3–63.3) | 18.4(4.4–113.9) | 36.0(3.9–71.9) | 29.7(1.3–113.9) |
| Prior therapies, median (range) | 1 (1–3) | 1 (1–3) | 1 (1–3) | 1 (1–3) |
| Prior therapy type, n (%) | ||||
| Rituximab | 2 (66.7) | 4 (44.4) | 8 (88.9) | 14 (66.7) |
| Alkylating agent | 3 (100) | 9 (100.0) | 9 (100.0) | 21 (100) |
| Anthracycline | 3 (100) | 7 (77.8) | 6 (66.7) | 16 (76.2) |
| Bortezomib | 1 (33.3) | 0 | 0 | 1 (4.8) |
| Purine analog | 1 (33.3) | 4 (44.4) | 6 (66.7) | 11 (52.4) |
ECOG, Eastern Cooperative Oncology Group; SLL/CLL, small lymphocytic lymphoma/chronic lymphocytic leukemia; BPDCN, blasticplasmacytoid dendritic cell neoplasm; LBMI, lymphoma bone marrow involvement; ALT/AST, alanine transaminase (ALT) and aspartate transaminase