Table 1.
The characteristic of include studies.
| Study | ClinicalTrials.govidentifier | Phase | Design | Disease | Treatment | No.ofpatients | Agerange | Male/female(n) | Median number ofprior regimen, (range) | ORR% | 12-month PFS rate | 12-month OS rate | mPFS(months) | Discontinued treatment due of Aes (n) | Any grade adverse events (n) | Grade≥3 adverse events (n) | Serious adverse events (n) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| O’Brien-2018 | NCT01476657 | I | multicohort, single arm |
relapsed or refractory CLL/SLL |
25 or 75 mg BID in 28-day cycles | 55 | 66(42–82) | 42/13 | 4(1–11) | 56.4% | 57.1% | 65.5% | ALL:15.7 TP53 mutation/17p-deletion:27.9 |
20 | _ | _ | _ |
| Flinn-2018 | NCT02004522 | III | multicenter, randomized |
relapsed or refractory CLL/SLL |
25 mg BID in 28-day cycles | 160 | 69(39-90) | 96/64 | 2(1-10) | 73.8% | 60.0% | 86.3% | ALL:13.3 TP53 mutation/17p-deletion:12.7 |
55 | 156 | 138 | 115 |
| Davids-2020 | NCT02049515 | III | two-arm, non-randomized |
relapsed or refractory CLL/SLL |
25 mg BID in 28-day cycles | 90 | 68(39–90) | 57/33 | 3(2-8) | 76.7% | 64.4% | 82.2% | ALL:15.7 TP53 mutation/17p-deletion:14.7 |
47 | 90 | 80 | 67 |
| Flinn-2018 | NCT01476657 | I | multicohort, single arm |
relapsed or refractory idolent NHL |
25 or 75 mg BID in 28-day cycles | 31 | 64(37-78) | 18/13 | 3 (1-8) | 58.1% | 58.1% | 77.4% | 9.5 | 6 | _ | _ | _ |
| Flinn-2019 | NCT01882803 | II | single arm | relapsed or refractory idolent NHL |
25 mg BID in 28-day cycles | 129 | 65(30-90) | 88/41 | 3 (1-18) | 47.3% | 31.8% | 76.7% | 14.7 | 40 | 128 | 114 | 74 |
| Zheng-2021 | NCT04707079 | II | multicenter, single arm |
relapsed or refractory Follicular lymphoma |
25 mg BID in 28-day cycles | 23 | 49(31-70) | 16/7 | ≥2 | 82.6% | _ | _ | _ | 21 | 12 | _ | |
| Izutsu-2020 | NCT02598570 | I | multicenter, single arm |
relapsed or refractory B cell NHL |
25 mg BID in 28-day cycles | 7 | 61(54–74) | 4/3 | 3 (1–5) | 71.4% | _ | _ | 2 | 7 | _ | 2 | |
| Flinn-2018 | NCT01476657 | I | multicohort, single arm |
relapsed or refractory B cell NHL |
25 or 75 mg BID in 28-day cycles | 36 | _ | _ | ≥1 | 27.8% | _ | _ | _ | _ | _ | _ | |
| Horwitz-2018 | NCT01476657 | I | multicohort, single arm |
relapsed or refractory T cell NHL |
25 or 75 mg BID in 28-day cycles | 35 | 64 (34-86) | 16/19 | 4 (1-10) | 40.0% | 31.4% | 65.7% | PTCL:8.3 CTCL:4.5 |
13 | 34 | 24 | 20 |
| Horwitz-2019 | NCT02783625 | I | single arm | relapsed or refractory T cell NHL |
25 or 75 mg BID in 1 month lead-in |
16 | _ | _ | ≥1 | 50.0% | _ | _ | _ | _ | _ | _ | |
| Zinzani-2022 | NCT03372057 | II | multicenter, parallel cohort |
relapsed or refractory T cell NHL |
25 mg BID after 75 mg BID for 2 cycles | 101 | 67(21-92) | _ | 3 (1–9) | 48.5% | _ | _ | 3.6 | 20 | _ | _ | _ |