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In a recent article on Lymphoma Hub, the use of oral 5-azacytidine (AZA) and romidepsin (ROMI) to target epigenetic dysregulation in the treatment of peripheral T-cell lymphoma (PTCL) was discussed. The article centered on the phase II portion of a phase I/II trial (NCT01998035) which was presented at the International Conference on Malignant Lymphoma (ICML) in June 2019. Owen O’Connor, Columbia University Medical Center, US, and team have now published the phase I part of the study in Blood.1
This phase I trial assessed the effect of AZA plus ROMI in the treatment of relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin Lymphoma (HL), with emphasis on patients with PTCL. The primary objectives were to determine the dose-limiting toxicity (DLT) of the combined treatment in the first cycle and the maximum tolerated dose (MTD), which is defined as the highest dose level resulting in less than a third of the treatment cohort experiencing DLT in the first cycle.
O’Connor and colleagues concluded that the results of this study highlight the utility of this combination treatment for patients with R/R PTCL due to the high CR rates seen in such a heavily pre-treated group, enabling them to be considered for AHSCT. The study also suggests that this treatment may work well for AITL, but this would need validating in a larger sample. They go on to state that although the number of patients included was low, the phase II results and validation of these findings is ongoing and should confirm these findings.
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