Demographics and clinical characteristics
| . | Phase I* (n = 60) No. (%) . | Phase II* (n = 95) No. (%) . | Phase III* (n = 23) No. (%) . |
|---|---|---|---|
| Number of trials with TCL patients only | 27 | 66 | 19 |
| Total number of patients | 1791 | 3818 | 2782 |
| Number of T-cell lymphoma patients | 1075 | 3246 | 1888 |
| No. of patients (median, IQR)† | 25 (13-29) | 37 (25-49) | 58 (42-82) |
| Age (median, IQR)† | 62 (55-66) | 61 (55-64) | 58 (51-67) |
| Male, % (median, IQR) | 62 (56-68) | 62 (52-70) | 66 (65-67) |
| No. of trials reporting prior therapies | 34 (57) | 61 (64) | 18 (78) |
| No. of prior therapies (median, IQR)† | 3 (2-3) | 2 (0-3) | 0 (0-2) |
| No. of trials reporting IPI score ≥3‡,§ | 9 (15) | 27 (28) | 9 (39) |
| Percentage of patients with IPI score ≥3 (median, IQR)‖ | 60 (36-61) | 45 (41-56) | 46 (31-52) |
| Therapy | |||
| Novel SA | 36 (60) | 49 (52) | 5 (22) |
| CC | 7 (12) | 30 (32) | 15 (65) |
| SA + CC | 7 (12) | 9 (9) | 3 (13) |
| SA + SA | 10 (17) | 7 (7) | 0 (0) |
| Drug class* | |||
| Cytotoxic chemotherapy¶ | 10 (15) | 34 (33) | 17 (74) |
| Epigenetic modifiers# | 10 (15) | 16 (16) | 1 (4) |
| Antibody-drug conjugates** | 4 (6) | 6 (6) | 1 (20) |
| Therapeutic antibodies†† | 9 (13) | 14 (14) | 0 (0) |
| SMis‡‡ | 11 (16) | 10 (10) | 1 (4) |
| IMIDs§§ | 3 (4) | 7 (7) | 0 (0) |
| Other‖‖ | 10 (15) | 8 (8) | 0 (0) |
| Combination¶¶ | 11 (16) | 8 (8) | 3 (13) |
| Calendar period of publication | |||
| Before 2009 | 4 (7) | 12 (13) | 1 (4) |
| 2009-2015 | 19 (32) | 36 (38) | 2 (9) |
| 2016 and after | 37 (62) | 47 (49) | 20 (87) |
| Treatment setting* | |||
| Upfront | 8 (13) | 29 (31) | 17 (74) |
| Relapsed | 51 (85) | 61 (64) | 6 (26) |
| Upfront + relapsed | 1 (2) | 5 (5) | 0 (0) |
| . | Phase I* (n = 60) No. (%) . | Phase II* (n = 95) No. (%) . | Phase III* (n = 23) No. (%) . |
|---|---|---|---|
| Number of trials with TCL patients only | 27 | 66 | 19 |
| Total number of patients | 1791 | 3818 | 2782 |
| Number of T-cell lymphoma patients | 1075 | 3246 | 1888 |
| No. of patients (median, IQR)† | 25 (13-29) | 37 (25-49) | 58 (42-82) |
| Age (median, IQR)† | 62 (55-66) | 61 (55-64) | 58 (51-67) |
| Male, % (median, IQR) | 62 (56-68) | 62 (52-70) | 66 (65-67) |
| No. of trials reporting prior therapies | 34 (57) | 61 (64) | 18 (78) |
| No. of prior therapies (median, IQR)† | 3 (2-3) | 2 (0-3) | 0 (0-2) |
| No. of trials reporting IPI score ≥3‡,§ | 9 (15) | 27 (28) | 9 (39) |
| Percentage of patients with IPI score ≥3 (median, IQR)‖ | 60 (36-61) | 45 (41-56) | 46 (31-52) |
| Therapy | |||
| Novel SA | 36 (60) | 49 (52) | 5 (22) |
| CC | 7 (12) | 30 (32) | 15 (65) |
| SA + CC | 7 (12) | 9 (9) | 3 (13) |
| SA + SA | 10 (17) | 7 (7) | 0 (0) |
| Drug class* | |||
| Cytotoxic chemotherapy¶ | 10 (15) | 34 (33) | 17 (74) |
| Epigenetic modifiers# | 10 (15) | 16 (16) | 1 (4) |
| Antibody-drug conjugates** | 4 (6) | 6 (6) | 1 (20) |
| Therapeutic antibodies†† | 9 (13) | 14 (14) | 0 (0) |
| SMis‡‡ | 11 (16) | 10 (10) | 1 (4) |
| IMIDs§§ | 3 (4) | 7 (7) | 0 (0) |
| Other‖‖ | 10 (15) | 8 (8) | 0 (0) |
| Combination¶¶ | 11 (16) | 8 (8) | 3 (13) |
| Calendar period of publication | |||
| Before 2009 | 4 (7) | 12 (13) | 1 (4) |
| 2009-2015 | 19 (32) | 36 (38) | 2 (9) |
| 2016 and after | 37 (62) | 47 (49) | 20 (87) |
| Treatment setting* | |||
| Upfront | 8 (13) | 29 (31) | 17 (74) |
| Relapsed | 51 (85) | 61 (64) | 6 (26) |
| Upfront + relapsed | 1 (2) | 5 (5) | 0 (0) |
IMIDs, immunomodulatory drugs; IQR, interquartile range.
Combined phase trials such as I/II, II/III, or I/II/III, trials investigating multiple drug classes or combined upfront, and relapsed/refractory trials were included in >1 phase or category in Table 1 for analysis, thereby making the number of trials in each of these categories greater than the number of total trials included for the overall meta-analysis, but they were counted only once in the analysis and not duplicated.
Median (no. of patients per trial, age, male percentage, no. of prior therapies, IPI score >3) reflects information reported by studies at trial enrollment.
IPI score calculated based on age >60 years, stage III or IV Ann Arbor system, elevated lactate dehydrogenase, Eastern Cooperative Oncology Group performance status of 2 to 4, and ≥2 extra nodal sites of disease.
Represents number (percentage) of trials reporting patients with IPI score ≥3 at trial enrollment.
Represents percentage of patients with IPI score ≥3 at trial enrollment reported by the study.
Cytotoxic chemotherapy arm included anthracycline-, ifosfamide-, gemcitabine-, and platinum-based treatments.
Epigenetic modifiers included histone deacetylase inhibitors (romidepsin, belinostat, chidamide), DNA methyltransferase inhibitors (azacytidine and decitabine), and EZH1/2 inhibitors (tazemetostat and valmetostat).
Antibody-drug conjugates included brentuximab vedotin and camidanlumab tesirine.
Therapeutic antibodies included alemtuzumab, nivolumab, pembrolizumab, durvalumab, avelumab, and anti-CD47 monoclonal antibody TTI621 and TTI622.
SMis included inhibitor of PI3K/AKT/mTOR, JAK/STAT, ALK (duvelisib, tenalisib, everolimus, ruxolitinib, cerdulatinib, crizotinib), aurora kinase (alisertib), farnesyl transferase, and proteosome pathways (tipifarnib, fenritinide, bortezomib).
IMIDs included cereblon inhibitors (lenalidomide and CPI 818).
Drugs in the “other” category included ixazomib, avadomide, E777, darinaparsin, RH IL-15, valganciclovir, denileukin, bortezemib, carfilzomib, selinexor, 13 cis-retinoic acid, and interferon α.
Combination includes trials of cytotoxic chemotherapy with other drug classes.