Alemtuzumab and Rituximab in Aplastic Anemia

Summary

The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.

Timeline

Start

2011-07

Primary completion

2013-01

Completion

2014-01

Publications

• Background Young NS, Maciejewski J. The pathophysiology of acquired aplastic anemia. N Engl J Med. 1997 May 8;336(19):1365-72. doi: 10.1056/NEJM199705083361906. No abstract available.
• Background Young NS, Calado RT, Scheinberg P. Current concepts in the pathophysiology and treatment of aplastic anemia. Blood. 2006 Oct 15;108(8):2509-19. doi: 10.1182/blood-2006-03-010777. Epub 2006 Jun 15.
• Background Gomez-Almaguer D, Jaime-Perez JC, Garza-Rodriguez V, Chapa-Rodriguez A, Tarin-Arzaga L, Herrera-Garza JL, Ruiz-Arguelles GJ, Lopez-Otero A, Gonzalez-Llano O, Rodriguez-Romo L. Subcutaneous alemtuzumab plus cyclosporine for the treatment of aplastic anemia. Ann Hematol. 2010 Mar;89(3):299-303. doi: 10.1007/s00277-009-0816-5. Epub 2009 Aug 25.
• Background Takamatsu H, Yagasaki H, Takahashi Y, Hama A, Saikawa Y, Yachie A, Koizumi S, Kojima S, Nakao S. Aplastic anemia successfully treated with rituximab: the possible role of aplastic anemia-associated autoantibodies as a marker for response. Eur J Haematol. 2011 Jun;86(6):541-5. doi: 10.1111/j.1600-0609.2011.01612.x.
• Background Gomez-Almaguer D, Solano-Genesta M, Tarin-Arzaga L, Herrera-Garza JL, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias. Blood. 2010 Dec 2;116(23):4783-5. doi: 10.1182/blood-2010-06-291831. Epub 2010 Sep 14.
• Background Risitano AM, Selleri C, Serio B, Torelli GF, Kulagin A, Maury S, Halter J, Gupta V, Bacigalupo A, Socie G, Tichelli A, Schrezenmeier H, Marsh J, Passweg J, Rotoli B; Working Party Severe Aplastic Anaemia (WPSAA) of the European Group for Blood and Marrow Transplantation (EBMT). Alemtuzumab is safe and effective as immunosuppressive treatment for aplastic anaemia and single-lineage marrow failure: a pilot study and a survey from the EBMT WPSAA. Br J Haematol. 2010 Mar;148(5):791-6. doi: 10.1111/j.1365-2141.2009.08027.x. Epub 2009 Dec 7.

Drugs

Indications