A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study

Abstract

This phase II study to determine the safety and efficacy of denileukin diftitox (DD) and cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) enrolled patients with newly diagnosed peripheral T-cell lymphoma (PTCL). Forty-nine received DD 18 μg/kg/day (days 1, 2) with CHOP (day 3) every 21 days for ≤ 6–8 cycles. Intent-to-treat (ITT) and safety populations comprised all patients. In the ITT population, the overall response rate was 65%, median duration of response was 30 months and median progression-free survival was 12 months. Median overall survival was not attained at the end of the study, and the overall survival rate was 63.3%. The two most frequent treatment-related adverse events (AEs) were fatigue and nausea. Most frequent AEs ≥ grade 3 within the hematologic system were lymphopenia (24.5%), neutropenia (20.4%) and leukopenia (18.4%). Three treatment-related deaths occurred. DD plus CHOP was well tolerated, and progression-free and overall survival improved versus historical comparison with CHOP alone. Confirmation in larger trials is warranted.

Keywords::

• Denileukin diftitox
• CHOP
• lymphoma
• T-cell
• phase II
• clinical trial
• fusion protein toxin

Acknowledgements

This study was sponsored by Eisai Inc. Editorial support for this manuscript was provided by Sui Generis Health and by Peloton Advantage, LLC, and was funded by Eisai Inc. We thank Kara Nyberg, PhD, of Sui Generis Health for providing medical writing and editorial assistance, and Yvonne E. Yarker, PhD, CMPP, of Peloton Advantage, LLC, for providing editorial support.

Potential conflict of interest:

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