Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

Summary

Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.

Timeline

Start

2013-01

Primary completion

2016-12

Completion

2016-12

Publications

• Background Michel M. Classification and therapeutic approaches in autoimmune hemolytic anemia: an update. Expert Rev Hematol. 2011 Dec;4(6):607-18. doi: 10.1586/ehm.11.60.
• Background Randen U, Troen G, Tierens A, Steen C, Warsame A, Beiske K, Tjonnfjord GE, Berentsen S, Delabie J. Primary cold agglutinin-associated lymphoproliferative disease: a B-cell lymphoma of the bone marrow distinct from lymphoplasmacytic lymphoma. Haematologica. 2014 Mar;99(3):497-504. doi: 10.3324/haematol.2013.091702. Epub 2013 Oct 18.
• Background Berentsen S, Tjonnfjord GE. Diagnosis and treatment of cold agglutinin mediated autoimmune hemolytic anemia. Blood Rev. 2012 May;26(3):107-15. doi: 10.1016/j.blre.2012.01.002. Epub 2012 Feb 12.
• Background Berentsen S, Randen U, Vagan AM, Hjorth-Hansen H, Vik A, Dalgaard J, Jacobsen EM, Thoresen AS, Beiske K, Tjonnfjord GE. High response rate and durable remissions following fludarabine and rituximab combination therapy for chronic cold agglutinin disease. Blood. 2010 Oct 28;116(17):3180-4. doi: 10.1182/blood-2010-06-288647. Epub 2010 Jul 15.
• Background Berentsen S, Beiske K, Tjonnfjord GE. Primary chronic cold agglutinin disease: an update on pathogenesis, clinical features and therapy. Hematology. 2007 Oct;12(5):361-70. doi: 10.1080/10245330701445392.
• Background Berentsen S, Ulvestad E, Langholm R, Beiske K, Hjorth-Hansen H, Ghanima W, Sorbo JH, Tjonnfjord GE. Primary chronic cold agglutinin disease: a population based clinical study of 86 patients. Haematologica. 2006 Apr;91(4):460-6.
• Background Berentsen S, Ulvestad E, Gjertsen BT, Hjorth-Hansen H, Langholm R, Knutsen H, Ghanima W, Shammas FV, Tjonnfjord GE. Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients. Blood. 2004 Apr 15;103(8):2925-8. doi: 10.1182/blood-2003-10-3597. Epub 2003 Dec 30.
• Background Schollkopf C, Kjeldsen L, Bjerrum OW, Mourits-Andersen HT, Nielsen JL, Christensen BE, Jensen BA, Pedersen BB, Taaning EB, Klausen TW, Birgens H. Rituximab in chronic cold agglutinin disease: a prospective study of 20 patients. Leuk Lymphoma. 2006 Feb;47(2):253-60. doi: 10.1080/10428190500286481.
• Background Gueli A, Gottardi D, Hu H, Ricca I, De Crescenzo A, Tarella C. Efficacy of rituximab-bendamustine in cold agglutinin haemolytic anaemia refractory to previous chemo-immunotherapy: a case report. Blood Transfus. 2013 Apr;11(2):311-4. doi: 10.2450/2012.0166-12. Epub 2013 Jan 22. No abstract available.
• Background Berentsen S, Ulvestad E, Tjonnfjord GE. B-lymphocytes as targets for therapy in chronic cold agglutinin disease. Cardiovasc Hematol Disord Drug Targets. 2007 Sep;7(3):219-27. doi: 10.2174/187152907781745279.
• Background Ulvestad E, Berentsen S, Bo K, Shammas FV. Clinical immunology of chronic cold agglutinin disease. Eur J Haematol. 1999 Oct;63(4):259-66. doi: 10.1111/j.1600-0609.1999.tb01887.x.
• Background Ulvestad E, Berentsen S, Mollnes TE. Acute phase haemolysis in chronic cold agglutinin disease. Scand J Immunol. 2001 Jul-Aug;54(1-2):239-42. doi: 10.1046/j.1365-3083.2001.00960.x.
• Background Berentsen S. How I manage cold agglutinin disease. Br J Haematol. 2011 May;153(3):309-17. doi: 10.1111/j.1365-2141.2011.08643.x. Epub 2011 Mar 8.
• Background Swiecicki PL, Hegerova LT, Gertz MA. Cold agglutinin disease. Blood. 2013 Aug 15;122(7):1114-21. doi: 10.1182/blood-2013-02-474437. Epub 2013 Jun 11.
• Background Stone MJ. Heating up cold agglutinins. Blood. 2010 Oct 28;116(17):3119-20. doi: 10.1182/blood-2010-07-297523.
• Background Berentsen S, Tjonnfjord GE, Shammas FV, Bergheim J, Hammerstrom J, Langholm R, Ulvestad E. No response to cladribine in five patients with chronic cold agglutinin disease. Eur J Haematol. 2000 Jul;65(1):88-90. doi: 10.1034/j.1600-0609.2000.9l201.x. No abstract available.
• Background Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. doi: 10.1016/S1470-2045(15)00447-7. Epub 2015 Dec 5.
• Berentsen S, Randen U, Oksman M, Birgens H, Tvedt THA, Dalgaard J, Galteland E, Haukas E, Brudevold R, Sorbo JH, Naess IA, Malecka A, Tjonnfjord GE. Bendamustine plus rituximab for chronic cold agglutinin disease: results of a Nordic prospective multicenter trial. Blood. 2017 Jul 27;130(4):537-541. doi: 10.1182/blood-2017-04-778175. Epub 2017 May 22.

Drugs

Indications