Combinatorial epigenetic therapy in diffuse large B cell lymphoma pre-clinical models and patients

Clinical Epigenetics

Table 1 Overview of the phase Ib study on the combination of vorinostat and azacitidine in RR-DLBCL patients

Open-label phase Ib (NCT01120834)
Key enrollment criteria	Dose level 1	Key endpoints	Post-study
R/R-DLBCL	AZA 55 mg/m² s.q. D 1 to 5	Primary: MTD or MAD	ORR and subsequent OS
R/R-DLBCL	VST 300 mg/m² BID D 1 to 7		ORR and subsequent OS
Relapsed after or ineligible for ASCT	Dose level 2
ANC > or = 1000/μL	AZA 75 mg/m² s.q. D 1 to 5	Secondary: Efficacy
ANC > or = 1000/μL	VST 200 mg/m² BID D 1 to 7
Platelets > or = 75/μL	Dose level 3
Adequate renal and hepatic functions	AZA 55 mg/m² s.q. D 1 to 5
Adequate renal and hepatic functions	VST 300 mg/m² BID D 1 to 14
No prior treatment with HDACIs	Dose level 4
QTc no more than 0.470	AZA 75 mg/m² s.q. D 1 to 5
QTc no more than 0.470	VST 200 mg/m² BID D 1 to 14

ISSN: 1868-7083