Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)

Summary

The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

Timeline

Start

2008-02

Primary completion

2011-02

Completion

2011-11

Publications

• Background Cheson BD. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs. 2005;19(5):309-22. doi: 10.2165/00063030-200519050-00004.
• Background Chopra R, Goldstone AH, Pearce R, Philip T, Petersen F, Appelbaum F, De Vol E, Ernst P. Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data. J Clin Oncol. 1992 Nov;10(11):1690-5. doi: 10.1200/JCO.1992.10.11.1690.
• Background Dean RM, Fowler DH, Wilson WH, Odom J, Steinberg SM, Chow C, Kasten-Sportes C, Gress RE, Bishop MR. Efficacy of reduced-intensity allogeneic stem cell transplantation in chemotherapy-refractory non-hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Aug;11(8):593-9. doi: 10.1016/j.bbmt.2005.04.005.
• Background Escalon MP, Champlin RE, Saliba RM, Acholonu SA, Hosing C, Fayad L, Giralt S, Ueno NT, Maadani F, Pro B, Donato M, McLaughlin P, Khouri IF. Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. J Clin Oncol. 2004 Jun 15;22(12):2419-23. doi: 10.1200/JCO.2004.09.092.
• Background Fietz T, Uharek L, Gentilini C, Muessig A, Rieger K, Marinets O, Sandrock D, Munz DL, Glass B, Thiel E, Blau IW. Allogeneic hematopoietic cell transplantation following conditioning with 90Y-ibritumomab-tiuxetan. Leuk Lymphoma. 2006 Jan;47(1):59-63. doi: 10.1080/10428190500260478.
• Background Frater JL, Hsi ED. Properties of the mantle cell and mantle cell lymphoma. Curr Opin Hematol. 2002 Jan;9(1):56-62. doi: 10.1097/00062752-200201000-00010.
• Background Freytes CO, Loberiza FR, Rizzo JD, Bashey A, Bredeson CN, Cairo MS, Gale RP, Horowitz MM, Klumpp TR, Martino R, McCarthy PL, Molina A, Pavlovsky S, Pecora AL, Serna DS, Tsai T, Zhang MJ, Vose JM, Lazarus HM, van Besien K; Lymphoma Working Committee of the International Bone Marrow Transplant Registry. Myeloablative allogeneic hematopoietic stem cell transplantation in patients who experience relapse after autologous stem cell transplantation for lymphoma: a report of the International Bone Marrow Transplant Registry. Blood. 2004 Dec 1;104(12):3797-803. doi: 10.1182/blood-2004-01-0231. Epub 2004 Jul 27.
• Background Gianni AM, Cortelazzo S, Magni M, Martelli M; Michelangelo Cooperative. Rituximab: enhancing stem cell transplantation in mantle cell lymphoma. Bone Marrow Transplant. 2002 Feb;29 Suppl 1:S10-3. doi: 10.1038/sj.bmt.1703296.
• Background Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. doi: 10.1016/j.bbmt.2006.03.014.
• Background Grigg A, Ritchie D. Graft-versus-lymphoma effects: clinical review, policy proposals, and immunobiology. Biol Blood Marrow Transplant. 2004 Sep;10(9):579-90. doi: 10.1016/j.bbmt.2004.05.008.
• Background Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
• Background Johnson TA, Press OW. Synergistic cytotoxicity of iodine-131-anti-CD20 monoclonal antibodies and chemotherapy for treatment of B-cell lymphomas. Int J Cancer. 2000 Jan 1;85(1):104-12. doi: 10.1002/(sici)1097-0215(20000101)85:13.0.co;2-g.
• Background Jones RJ, Ambinder RF, Piantadosi S, Santos GW. Evidence of a graft-versus-lymphoma effect associated with allogeneic bone marrow transplantation. Blood. 1991 Feb 1;77(3):649-53.
• Background Khouri IF, Keating M, Korbling M, Przepiorka D, Anderlini P, O'Brien S, Giralt S, Ippoliti C, von Wolff B, Gajewski J, Donato M, Claxton D, Ueno N, Andersson B, Gee A, Champlin R. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998 Aug;16(8):2817-24. doi: 10.1200/JCO.1998.16.8.2817.
• Background Khouri IF, Lee MS, Romaguera J, Mirza N, Kantarjian H, Korbling M, Albitar M, Giralt S, Samuels B, Anderlini P, Rodriguez J, von Wolff B, Gajewski J, Cabanillas F, Champlin R. Allogeneic hematopoietic transplantation for mantle-cell lymphoma: molecular remissions and evidence of graft-versus-malignancy. Ann Oncol. 1999 Nov;10(11):1293-9. doi: 10.1023/a:1008380527502.
• Background Khouri IF, Lee MS, Saliba RM, Jun G, Fayad L, Younes A, Pro B, Acholonu S, McLaughlin P, Katz RL, Champlin RE. Nonablative allogeneic stem-cell transplantation for advanced/recurrent mantle-cell lymphoma. J Clin Oncol. 2003 Dec 1;21(23):4407-12. doi: 10.1200/JCO.2003.05.501.
• Background Maris MB, Sandmaier BM, Storer BE, Chauncey T, Stuart MJ, Maziarz RT, Agura E, Langston AA, Pulsipher M, Storb R, Maloney DG. Allogeneic hematopoietic cell transplantation after fludarabine and 2 Gy total body irradiation for relapsed and refractory mantle cell lymphoma. Blood. 2004 Dec 1;104(12):3535-42. doi: 10.1182/blood-2004-06-2275. Epub 2004 Aug 10.
• Background Milpied N, Deconinck E, Gaillard F, Delwail V, Foussard C, Berthou C, Gressin R, Lucas V, Colombat P, Harousseau JL; Groupe Ouest-Est des Leucemies et des Autres Maladies du Sang. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95. doi: 10.1056/NEJMoa031770.
• Background Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. doi: 10.1182/blood-2004-03-1105. Epub 2004 Aug 10.
• Background Nademanee A, Forman SJ. Role of hematopoietic stem cell transplantation for advanced-stage diffuse large cell B-cell lymphoma-B. Semin Hematol. 2006 Oct;43(4):240-50. doi: 10.1053/j.seminhematol.2006.07.006.
• Background Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995 Dec 7;333(23):1540-5. doi: 10.1056/NEJM199512073332305.
• Background Ratanatharathorn V, Uberti J, Karanes C, Abella E, Lum LG, Momin F, Cummings G, Sensenbrenner LL. Prospective comparative trial of autologous versus allogeneic bone marrow transplantation in patients with non-Hodgkin's lymphoma. Blood. 1994 Aug 15;84(4):1050-5.
• Background Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.
• Background Rodriguez R, Nademanee A, Ruel N, Smith E, Krishnan A, Popplewell L, Zain J, Patane K, Kogut N, Nakamura R, Sarkodee-Adoo C, Forman SJ. Comparison of reduced-intensity and conventional myeloablative regimens for allogeneic transplantation in non-Hodgkin's lymphoma. Biol Blood Marrow Transplant. 2006 Dec;12(12):1326-34. doi: 10.1016/j.bbmt.2006.08.035.
• Background Schimmer AD, Jamal S, Messner H, Keating A, Meharchand J, Huebsch L, Walker I, Benger A, Gluck S, Smith A. Allogeneic or autologous bone marrow transplantation (BMT) for non-Hodgkin's lymphoma (NHL): results of a provincial strategy. Ontario BMT Network, Canada. Bone Marrow Transplant. 2000 Oct;26(8):859-64. doi: 10.1038/sj.bmt.1702625.
• Background Shenkier TN, Voss N, Fairey R, Gascoyne RD, Hoskins P, Klasa R, Klimo P, O'Reilly SE, Sutcliffe S, Connors JM. Brief chemotherapy and involved-region irradiation for limited-stage diffuse large-cell lymphoma: an 18-year experience from the British Columbia Cancer Agency. J Clin Oncol. 2002 Jan 1;20(1):197-204. doi: 10.1200/JCO.2002.20.1.197.
• Background Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63.
• Background Vandenberghe E, Ruiz de Elvira C, Loberiza FR, Conde E, Lopez-Guillermo A, Gisselbrecht C, Guilhot F, Vose JM, van Biesen K, Rizzo JD, Weisenburger DD, Isaacson P, Horowitz MM, Goldstone AH, Lazarus HM, Schmitz N. Outcome of autologous transplantation for mantle cell lymphoma: a study by the European Blood and Bone Marrow Transplant and Autologous Blood and Marrow Transplant Registries. Br J Haematol. 2003 Mar;120(5):793-800. doi: 10.1046/j.1365-2141.2003.04140.x.
• Background Winter JN. Combining yttrium 90-labeled ibritumomab tiuxetan with high-dose chemotherapy and stem cell support in patients with relapsed non-Hodgkin's lymphoma. Clin Lymphoma. 2004 Oct;5 Suppl 1:S22-6. doi: 10.3816/clm.2004.s.005.
• Bouabdallah K, Furst S, Asselineau J, Chevalier P, Tournilhac O, Ceballos P, Vigouroux S, Tabrizi R, Doussau A, Bouabdallah R, Mohty M, Le Gouill S, Blaise D, Milpied N. 90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas. Ann Oncol. 2015 Jan;26(1):193-198. doi: 10.1093/annonc/mdu503. Epub 2014 Oct 30.

Drugs

Indications