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Table 3 Experimental combinations in the front-line setting

From: Biomarker-driven management strategies for peripheral T cell lymphoma

Agent Trial/phase Subtype N ORR (%), CR (%) Median PFS (months) Median OS (months) AEs
Alemtuzumab Phase II [23] T-PLL 32 IV route: 91, 81 SubQ route: 33 67% at 12 months 37% at 48 months IV route: 2 patients with grade 4 hematologic AEs; 2 asymptomatic CMV reactivation; 2 skin reactionsSubQ route: 22% of patients died on treatment
Alemtuzumab + CHOP, “CHOP-C” GITIL phase II [71] PTCL, PTCL-NOS 58.3%, AITL 25%
ALCL, ALK− 12.5%
24 75, 71 48% at 2 years 53% at 2 years JC viral encephalitis in 1 pt
Invasive aspergillosis in 2 pts PJP in 1 pt
Staphylococcus sepsis in 1 pt
CHOP ± alemtuzumab followed by ASCT ACT-1 phase III [89] CD 52+ PTCL (no ALCL), PTCL-NOS 58%, AITL 21% 65 77, 52 37% at 3 years 52% at 3 years Grade 4 leukopenia (73% vs 35% in CHOP arm, p = 0.001)
Grade ≥ 3 bacterial/fungal infections and other serious AEs similar in both arms
*After 2pts developed systemic fungal infections, an amendment tapered ALZ dose from 360 mg (30 mg on days 1 + 2 of each CHOP course) to 120 mg (30 mg on day 1 of CHOP courses 1–4)
Alemtuzumab + CHOP-14 HOVON phase II [72] CD 52 + PTCL, PTCL-NOS 50%, AITL 30%, subcutaneous panniculitis-like (SPTCL) 15%, EATL 5% 20 90, 60 10 27 Neutropenic fever (40%), CMV reactivation (35%), secondary EBV-related lymphoma (15%)
Alemtuzumab + DA-EPOCH NCI phase I/II [73] CD 52+ PTCL, PTC
-NOS 35%,ATLL 32%, AITL 13%,CGDTCL 6%,epatosplenic TCL 6%
30 83.3, 57 6.6 20.2 5 treatment-related deaths:
2 sepsis, 1 cardiac arrest, 1 pneumonia, 1 disseminated toxoplasmosis
Romidepsin + CHOP, “Ro-CHOP”, LYSARC LYSA phase I/II [90] PTCL, PTCL-NOS 28%, AITL 22%
ALCL, ALK− 11%, EATL 6%, follicular PTCL 6%, ATLL 6%
37 69, 51 41% at 30 months 71% at 30 months Gr ≥ 3 AEs: neutropenia (89%), thrombocytopenia 78%), anemia (43%)
QT prolongation < 480 ms (37%); 480–500 ms (5%)
Lenalidomide + CHOP, “len-CHOP” LYSA phase II [77] AITL, pts > 59 years old 78 47.4,43.6 42.3% at 2 years 60.1% at 2 years 29% discontinuation rate due to toxicities (15 pts) or POD (8 pts)
4 secondary malignancies
5 treatment-related deaths (4 infections)
Lenalidomide + CHOEP, “len-CHOEP” T cell consortium phase II [76] PTCL, PTCL-NOS 57.5%,
AITL 30%
ALCL, ALK− 12.5%
12 68,48 68% at 1 year 89% at 1 year 25% discontinuation rate due to toxicity (6pts) or POD (4pts)
5 deaths: 1 POD, 2 sepsis, 1 cardiac arrest, 1 secondary malignancy (AML)
Belinostat + CHOP Bel-CHOP phase I [74] PTCL, PTCL-NOS 43%, ATIL 39%
ALCL, ALK+ 9%
ALCL, ALK− 4%
23 89, 72 Not reported Not reported Gr ≥ 3 AEs: neutropenia (26%), anemia (22%), lymphopenia (17%)
Pralatrexate alternating with CEOP T cell Consortium phase II [78] PTCL,PTCL-NOS 64%, AITL 24%
ALC, ALK− 12%
33 70, 52 39% at 2 years 60% at 2 years Gr ≥ 3 AEs: anemia (27%), thrombocytopenia (12%), febrile neutropenia (18%), mucositis (18%), sepsis (15%), elevated creatinine (12%), elevated and liver transaminases (12%)
Chidamide + CHOP Phase Ib/II [75] PTCL
,PTCL-NOS 40%, AITL 26.7%
ALCL, ALK+ 13.3%
ALCL, ALK− 10%
30 82.1, 46.4 14,54.3% at 12 months Not reached,100% at 12 months Gr ≥ 3 AEs: leukopenia (90%), neutropenia (83.3%), lymphopenia (40%), vomiting (13.3%), thrombocytopenia (10%), and febrile neutropenia (10%)