R±CEOP90 Versus R±CEOP75 in Newly Diagnosed Young Patients With Medium/High-risk DLBCL

Summary

This clinical trial is designed to compare the efficacy and safety of R±CEOP90 containing high-dose epirubicin and R±CEOP75 containing standard epirubicin in newly diagnosed young patients with medium/high-risk diffuse large B-cell lymphoma. Half of the participants receive R±CEOP regimen containing 90mg/m2 epirubicin, while the other half of participants receive R±CEOP regimen containing 75mg/m2 epirubicin. Via exploring whether high-dose epirubicin shall achieve better efficacy and less toxicity, we hope to optimize current treatment choice for young patients with medium/high-risk diffuse large B-cell lymphoma.

Timeline

Start

2016-07

Primary completion

2017-07

Completion

2017-07

Publications

• Background Economopoulos T, Dimopoulos MA, Mellou S, Pavlidis N, Samantas E, Nicolaides C, Tsatalas C, Papadopoulos A, Papageogriou E, Papasavvas P, Fountzilas G. Treatment of intermediate- and high-grade non-Hodgkin's lymphoma using CEOP versus CNOP. Eur J Haematol. 2002 Mar;68(3):135-43. doi: 10.1034/j.1600-0609.2002.01620.x.
• Background Rossini F, Terruzzi E, Perego D, Miccolis I, Rivolta F, Manca E, Pogliani EM. Long-term follow-up of patients with intermediate or high-grade non-Hodgkin lymphoma treated with a combination of cyclophosphamide, epirubicin, vincristine, and prednisone. Cancer. 2004 Jan 15;100(2):350-5. doi: 10.1002/cncr.11907.
• Background Chim CS, Kwong YL, Lie AK, Lee CK, Liang R. CEOP treatment results and validity of the International Prognostic Index in Chinese patients with aggressive non-Hodgkin's lymphoma. Hematol Oncol. 1998 Sep;16(3):117-23. doi: 10.1002/(sici)1099-1069(199809)16:33.0.co;2-0.
• Background Lambertenghi Deliliers G, Butti C, Baldini L, Ceriani A, Lombardi F, Luoni M, Montalbetti L, Pavia G, Pinotti G, Pogliani E, et al. A cooperative study of epirubicin with cyclophosphamide, vincristine and prednisone (CEOP) in non-Hodgkin's lymphoma. Haematologica. 1995 Jul-Aug;80(4):318-24.
• Background Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
• Background Pfreundschuh M, Schubert J, Ziepert M, Schmits R, Mohren M, Lengfelder E, Reiser M, Nickenig C, Clemens M, Peter N, Bokemeyer C, Eimermacher H, Ho A, Hoffmann M, Mertelsmann R, Trumper L, Balleisen L, Liersch R, Metzner B, Hartmann F, Glass B, Poeschel V, Schmitz N, Ruebe C, Feller AC, Loeffler M; German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol. 2008 Feb;9(2):105-16. doi: 10.1016/S1470-2045(08)70002-0. Epub 2008 Jan 15.
• Background Recher C, Coiffier B, Haioun C, Molina TJ, Ferme C, Casasnovas O, Thieblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquieres H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.
• Background Basaran M, Bavbek ES, Sakar B, Eralp Y, Alici S, Tas F, Yaman F, Dogan O O, Camlica H, Onat H. Treatment of aggressive non-Hodgkin's lymphoma with dose-intensified epirubicin in combination of cyclophosphamide, vincristine, and prednisone (CEOP-100): a phase II study. Am J Clin Oncol. 2001 Dec;24(6):570-5. doi: 10.1097/00000421-200112000-00008.
• Background Pronzato P, Lionetto R, Botto F, Pensa F, Tognoni A. High-dose intensity cyclophosphamide, epidoxorubicin, vincristine and prednisone by shortened intervals and granulocyte colony-stimulating factor in non-Hodgkin's lymphoma: a phase II study. Br J Cancer. 1998 Sep;78(6):777-80. doi: 10.1038/bjc.1998.578.
• Background Zinzani PL, Mazza P, Gherlinzoni F, Zanchini R, Bocchia M, Aitini E, Cavazzini G, Amurri B, Gobbi M, Tura S. CEOP regimen in the treatment of advanced low-grade non-Hodgkin's lymphomas: preliminary report. Tumori. 1990 Dec 31;76(6):533-6. doi: 10.1177/030089169007600603.
• Background Abate G, Comella P, Di Pietro N, Ganzina F, Pergola M, Silvestro P, Basso A, Salvatore M, Zarrilli D. Epirubicin in combination chemotherapy in the treatment of advanced stage non-Hodgkin's lymphomas. Tumori. 1987 Feb 28;73(1):43-7. doi: 10.1177/030089168707300108.

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