Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multicentre Prospective Phase II Single Arm Trial of the French Study Group of Cutaneous Lymphoma

Summary

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients. If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

Timeline

Start

2012-07

Primary completion

2015-03

Completion

2015-08

Publications

• Results Mareschal S, Pham-Ledard A, Viailly PJ, Dubois S, Bertrand P, Maingonnat C, Fontanilles M, Bohers E, Ruminy P, Tournier I, Courville P, Lenormand B, Duval AB, Andrieu E, Verneuil L, Vergier B, Tilly H, Joly P, Frebourg T, Beylot-Barry M, Merlio JP, Jardin F. Identification of Somatic Mutations in Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type by Massive Parallel Sequencing. J Invest Dermatol. 2017 Sep;137(9):1984-1994. doi: 10.1016/j.jid.2017.04.010. Epub 2017 May 4.
• Results Pham-Ledard A, Cappellen D, Martinez F, Vergier B, Beylot-Barry M, Merlio JP. MYD88 somatic mutation is a genetic feature of primary cutaneous diffuse large B-cell lymphoma, leg type. J Invest Dermatol. 2012 Aug;132(8):2118-20. doi: 10.1038/jid.2012.102. Epub 2012 Apr 12. No abstract available.
• Results Pham-Ledard A, Prochazkova-Carlotti M, Andrique L, Cappellen D, Vergier B, Martinez F, Grange F, Petrella T, Beylot-Barry M, Merlio JP. Multiple genetic alterations in primary cutaneous large B-cell lymphoma, leg type support a common lymphomagenesis with activated B-cell-like diffuse large B-cell lymphoma. Mod Pathol. 2014 Mar;27(3):402-11. doi: 10.1038/modpathol.2013.156. Epub 2013 Sep 13.
• Results Pham-Ledard A, Beylot-Barry M, Barbe C, Leduc M, Petrella T, Vergier B, Martinez F, Cappellen D, Merlio JP, Grange F. High frequency and clinical prognostic value of MYD88 L265P mutation in primary cutaneous diffuse large B-cell lymphoma, leg-type. JAMA Dermatol. 2014 Nov;150(11):1173-9. doi: 10.1001/jamadermatol.2014.821.
• Results Pham-Ledard A, Prochazkova-Carlotti M, Deveza M, Laforet MP, Beylot-Barry M, Vergier B, Parrens M, Feuillard J, Merlio JP, Gachard N. Molecular analysis of immunoglobulin variable genes supports a germinal center experienced normal counterpart in primary cutaneous diffuse large B-cell lymphoma, leg-type. J Dermatol Sci. 2017 Nov;88(2):238-246. doi: 10.1016/j.jdermsci.2017.07.008. Epub 2017 Jul 26.
• Results Menguy S, Prochazkova-Carlotti M, Beylot-Barry M, Saltel F, Vergier B, Merlio JP, Pham-Ledard A. PD-L1 and PD-L2 Are Differentially Expressed by Macrophages or Tumor Cells in Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type. Am J Surg Pathol. 2018 Mar;42(3):326-334. doi: 10.1097/PAS.0000000000000983.
• Results Beylot-Barry M, Mermin D, Maillard A, Bouabdallah R, Bonnet N, Duval-Modeste AB, Mortier L, Ingen-Housz-Oro S, Ram-Wolff C, Barete S, Dalle S, Maubec E, Quereux G, Templier I, Bagot M, Grange F, Joly P, Vergier B, Vially PJ, Gros A, Pham-Ledard A, Frison E, Merlio JP. A Single-Arm Phase II Trial of Lenalidomide in Relapsing or Refractory Primary Cutaneous Large B-Cell Lymphoma, Leg Type. J Invest Dermatol. 2018 Sep;138(9):1982-1989. doi: 10.1016/j.jid.2018.03.1516. Epub 2018 Mar 27.
• Results Beylot-Barry M. [Cutaneous lymphomas: breakthroughs and future prospects in 2018]. Ann Dermatol Venereol. 2018 Dec;145(12S):S10-S11. doi: 10.1016/j.annder.2018.09.160. Epub 2018 Nov 1. No abstract available. French.

Drugs

Indications