Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Summary

The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.

Timeline

Start

2012-02

Primary completion

2015-07

Completion

2016-07

Publications

• Background Bernengo MG, Novelli M, Quaglino P, Lisa F, De Matteis A, Savoia P, Cappello N, Fierro MT. The relevance of the CD4+ CD26- subset in the identification of circulating Sezary cells. Br J Dermatol. 2001 Jan;144(1):125-35. doi: 10.1046/j.1365-2133.2001.04014.x.
• Background Booken N, Heck M, Nicolay JP, Klemke CD, Goerdt S, Utikal J. Oral aprepitant in the therapy of refractory pruritus in erythrodermic cutaneous T-cell lymphoma. Br J Dermatol. 2011 Mar;164(3):665-7. doi: 10.1111/j.1365-2133.2010.10108.x. Epub 2011 Jan 28. No abstract available.
• Background Duval A, Dubertret L. Aprepitant as an antipruritic agent? N Engl J Med. 2009 Oct 1;361(14):1415-6. doi: 10.1056/NEJMc0906670. No abstract available.
• Background Cevikbas F, Steinhoff M, Ikoma A. Role of spinal neurotransmitter receptors in itch: new insights into therapies and drug development. CNS Neurosci Ther. 2011 Dec;17(6):742-9. doi: 10.1111/j.1755-5949.2010.00201.x. Epub 2010 Oct 15.
• Background Lambeir AM, Durinx C, Scharpe S, De Meester I. Dipeptidyl-peptidase IV from bench to bedside: an update on structural properties, functions, and clinical aspects of the enzyme DPP IV. Crit Rev Clin Lab Sci. 2003 Jun;40(3):209-94. doi: 10.1080/713609354.
• Background Ahmad S, Wang L, Ward PE. Dipeptidyl(amino)peptidase IV and aminopeptidase M metabolize circulating substance P in vivo. J Pharmacol Exp Ther. 1992 Mar;260(3):1257-61.
• Background Heymann E, Mentlein R. Liver dipeptidyl aminopeptidase IV hydrolyzes substance P. FEBS Lett. 1978 Jul 15;91(2):360-4. doi: 10.1016/0014-5793(78)81210-1. No abstract available.
• Background Mussap CJ, Geraghty DP, Burcher E. Tachykinin receptors: a radioligand binding perspective. J Neurochem. 1993 Jun;60(6):1987-2009. doi: 10.1111/j.1471-4159.1993.tb03484.x.
• Background Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008 Jun 5;358(23):2482-94. doi: 10.1056/NEJMra0706547. No abstract available.
• Background Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.
• Background Vonderheid EC, Bernengo MG, Burg G, Duvic M, Heald P, Laroche L, Olsen E, Pittelkow M, Russell-Jones R, Takigawa M, Willemze R; ISCL. Update on erythrodermic cutaneous T-cell lymphoma: report of the International Society for Cutaneous Lymphomas. J Am Acad Dermatol. 2002 Jan;46(1):95-106. doi: 10.1067/mjd.2002.118538.
• Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
• Zic JA, Straka BT, McGirt LY, Nian H, Yu C, Brown NJ. Aprepitant for the Treatment of Pruritus in Sezary Syndrome: A Randomized Crossover Clinical Trial. JAMA Dermatol. 2018 Oct 1;154(10):1221-1222. doi: 10.1001/jamadermatol.2018.2510.

Drugs

Indications