This multicenter, open-label, dose-finding, dose-escalation phase 1 trial was conducted in 2 parts: the first with the primary objective to evaluate the MTD of pralatrexate in combination with CHOP and the second part with an expansion cohort of 30 patients treated at the MTD to better characterize safety and efficacy of 6 cycles of the pralatrexate-CHOP (Folotyn-CHOP [Fol-CHOP]) combination.
The study was reviewed and approved by the institutional review boards at each of the 4 participating sites and was registered at as NCT02594267. The study conduct complied with the Declaration of Helsinki and followed International Conference on Harmonization Guidelines for Good Clinical Practice. All participating patients provided written informed consent and understood that study participation was voluntary.
The study was reviewed and approved by the institutional review boards at each of the 4 participating sites and was registered at as NCT02594267. The study conduct complied with the Declaration of Helsinki and followed International Conference on Harmonization Guidelines for Good Clinical Practice. All participating patients provided written informed consent and understood that study participation was voluntary.
