Table 2.

Novel Combinations Under Investigation in Previously Untreated PTCLs

Agent(s)	ClinicalTrials.gov	Phase	N	Treatment	Primary Endpoint(s)
Decitabine + CHOP vs CHOP	NCT03553537	III	100	Experimental arm: decitabine 10mg/m2 on day 1 to 5 + CHOP on day 6 every 4 weeks for 6 cycles Control arm: CHOP Q3 weeks for 6 cycles	PFS
CDOP vs CHOP	NCT03952572	III	244	Experimental arm: pegylated liposomal doxorubicin + cyclophosphamide + vincristine + prednisone Q3 weeks for 6 cycles Control arm: CHOP Q3 weeks for 6 cycles	CR and PR rates
Romidepsin + CHOEP + HSCT	NCT02223208	I/II	110	Phase I: romidepsin dose escalation on days 1 and 8 + CHOEP 21 Phase II: Romidepsin on days 1 and 8 + CHOEP 21 In phase I and II 3 cycles and if CR or PR 3 additional cycles followed by HSCT CR followed by ASCT PR followed by allogenic SCT	DLT PFS
CC-486 (oral 5-Azacitidine) + CHOP	NCT03542266	II	20	CC-486 300mg PO daily day −6 to 0 of cycle 1 and day 8 to 21 during cycles 1 to 5 CHOP Q3 weeks for 6 cycles	CR rate
Romidepsin + lenalidomide	NCT02232516	II	35	Romidepsin on days 1, 8 and 15 and lenalidomide daily on days 1 to 21 on a 28-day cycle for up to 1 year in the absence of PD or unacceptable toxicity	Efficacy of the combination
Nivolumab + standard DA-EPOCH	NCT03586999	II	18	Nivolumab IV + DA-EPOCH Q3 weeks for 6 cycles	Incidence of TEAE Efficacy (ORR, CR rate, PR rate, SD rate, PD rate)

Abbreviations: PFS, progression-free survival; CR, complete response; PR, partial response; DLT, dose-limiting toxicity; TEAE, treatment-emergent adverse events; ORR, objective response rate; SD, stable disease; PD, progressive disease; HSCT, hematological stem cell transplantation; ASCT, autologous stem cell transplantation; SCT, stem cell transplantation; PO, per os; IV, intravenously.