Puvvada S.D, et al. – This single-arm phase II study gauged if PXD-101 would increase major histocompatibility complex class II (MHCII) expression, synergize with Zevalin, and improve clinical outcomes. A priori identification of responding patients was precluded by the pleotropic effects of histone deacetylase inhibition and lack of clinical biomarkers. In this study, the importance of a clinically feasible biomarker was emphasized.

Methods

• Geared toward heavily pretreated patients with CD20-positive aggressive lymphomas (aNHL), this was a single-center open-label phase II trial (NCT01686165).
• Overall response rate (ORR) in aNHL patients treated with 2 cycles of PXD-101 followed by restaging CT and 1 cycle of Zevalin was the primary endpoint. 

Results

• This study incorporated five patients, and all were heavily pretreated.
• This study found therapy as well tolerated.
• In addition, nausea and vomiting were the most frequent adverse events.
• After receiving therapy, all patients progressed.
• The study did not achieve the required ORR to proceed to the next stage.