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

From: Combinatorial epigenetic therapy in diffuse large B cell lymphoma pre-clinical models and 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
VST 300 mg/m2 BID D 1 to 7
 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  
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   
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   
VST 200 mg/m2 BID D 1 to 14