Fludarabine, melphalan, and alemtuzumab conditioning in adults with standard-risk advanced acute myeloid leukemia and myelodysplastic syndrome

Journal of Clinical Oncology

Volumn 23, Issue 24, 2005, Pages 5728-5738

  Van Besien, Koen ^a   Artz, A ^a   Smith, S ^a   Cao, D ^a   Rich, S ^a   Godley, L ^a   Jones, D ^a   Del Cerro, P ^a   Bennett, D ^a   Casey, B ^a   Odenike, O ^a   Thirman, M ^a   Daugherty, C ^a   Wickrema, A ^a   Zimmerman, T ^a   Larson, R A ^a   Stock, W ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ALEMTUZUMAB; COTRIMOXAZOLE; FLUCONAZOLE; FLUDARABINE; GANCICLOVIR; GATIFLOXACIN; LEVOFLOXACIN; MELPHALAN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TACROLIMUS; VALACICLOVIR; VORICONAZOLE; ANTINEOPLASTIC AGENT; CANCER ANTIBODY; DRUG DERIVATIVE; MONOCLONAL ANTIBODY; VIDARABINE;

ACUTE GRANULOCYTIC LEUKEMIA; ADOLESCENT; ADULT; ADVANCED CANCER; AGED; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ANAPHYLAXIS; ARTICLE; CANCER RELAPSE; CANCER RISK; CANCER SURVIVAL; CHRONIC GRAFT VERSUS HOST DISEASE; CLINICAL TRIAL; COMORBIDITY; DRUG FATALITY; ENGRAFTMENT; FEVER; FOLLOW UP; HIGH RISK PATIENT; HUMAN; INFECTION PREVENTION; MAJOR CLINICAL STUDY; MULTIVARIATE ANALYSIS; MYCOSIS; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SCORING SYSTEM; UNIVARIATE ANALYSIS; URTICARIA; VIREMIA; VIRUS INFECTION; ACUTE DISEASE; DISEASE FREE SURVIVAL; FEMALE; GRAFT VERSUS HOST REACTION; IMMUNOSUPPRESSIVE TREATMENT; MALE; METHODOLOGY; MIDDLE AGED; MYELOID LEUKEMIA; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; REMISSION; STEM CELL TRANSPLANTATION;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEOPLASM; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE-FREE SURVIVAL; FEMALE; GRAFT VS HOST DISEASE; HUMANS; LEUKEMIA, MYELOID; MALE; MELPHALAN; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; REMISSION INDUCTION; STEM CELL TRANSPLANTATION; TRANSPLANTATION CONDITIONING; VIDARABINE;

EID: 24944582579     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.15.602     Document Type: Article

References (55)

1. van Besien K, Artz A, Stock W: Unrelated donor transplantation over the age of 55. Are we merely getting (b)older? Leukemia 19:31-33, 2005
2. Shimoni A, Kroger N, Zabelina T, et al: Hematopoietic stem-cell transplantation from unrelated donors in elderly patients (age>55 years) with hematologic malignancies: Older age is no longer a contraindication when using reduced intensity conditioning. Leukemia 19:7-12, 2005
3. Wong R, Giralt SA, Martin T, et al: Reduced-intensity conditioning for unrelated donor hematopoietic stem cell transplantation as treatment for myeloid malignancies in patients older than 55 years. Blood 102:3052-3059, 2003
4. Bensinger WI, Martin PJ, Storer B, et al: Transplantation of bone marrow as compared with peripheral-blood cells from HLA-identical relatives in patients with hematologic cancers. N Engl J Med 344:175-181, 2001
5. Flomenberg N, Baxter-Lowe LA, Confer D, et al: Impact of HLA class I and class II high resolution matching on outcomes of unrelated donor bone marrow transplantation: HLA-C mismatching is associated with a strong adverse effect on transplant outcome. Blood 104:1923-1930, 2004
6. Kernan NA, Bartsch G, Ash RC, et al: Analysis of 462 transplantations from unrelated donors facilitated by the National Marrow Donor Program. N Engl J Med 328:593-602, 1993
7. de Witte T, Hermans J, Vossen J, et al: Haematopoietic stem cell transplantation for patients with myelo-dysplastic syndromes and secondary acute myeloid leukaemias: A report on behalf of the Chronic Leukaemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Br J Haematol 110:620-630, 2000
8. Castro-Malaspina H, Harris RE, Gajewski J, et al: Unrelated donor marrow transplantation for myelodysplastic syndromes: Outcome analysis in 510 transplants facilitated by the National Marrow Donor Program. Blood 99:1943-1951, 2002
9. Sorror ML, Maris MB, Storer B, et al: Comparing morbidity and mortality of HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative and myeloablative conditioning: Influence of pretransplantation comorbidities. Blood 104:961-968, 2004
10. van Besien K, Devine S, Wickrema A, et al: Fludarabine melphalan is a suitable alternative to fludarabine-TBI based conditioning for allogeneic transplantation in patients with advanced hematologic malignancies. Hematol J 3:78a 2002 (suppl 1; abstr 580)
11. van Besien K, Devine S, Wickrema A, et al: Regimen-related toxicity after fludarabine-melphalan conditioning: A prospective study of 31 patients with hematologic malignancies. Bone Marrow Transplant 32:471-476, 2003
12. Van Besien KW, Demuynck H, LeMaistre CF, et al: High dose melphalan allows durable engraftment of allogeneic bone marrow. Bone Marrow Transplant 15:321-323, 1995
13. Singhal S, Powles R, Treleaven J, et al: Melphalan alone prior to allogeneic bone marrow transplantation from HLA-identical sibling donors for hematologic malignancies: Alloengraftment with potential preservation of fertility in women. Bone Marrow Transplant 18:1049-1055, 1996
14. Gandhi V, Plunkett W: Cellular and clinical pharmacology of fludarabine. Clin Pharmacokinet 41:93-103, 2002
15. Essell JH, Thompson JM, Harman GS, et al: Marked increase in veno-occlusive disease of the liver associated with methotrexate use for graft-versus-host disease prophylaxis in patients receiving busulfan/ cyclophosphamide. Blood 79: 2784-2788, 1992
16. Dulley FL, Kanfer EJ, Appelbaum FR, et al: Venocdusive disease of the liver after chemoradiotherapy and autologous bone marrow transplantation. Transplantation 43:870-873, 1987
17. Styler MJ, Crilley P, Biggs J, et al: Hepatic dysfunction following busulfan and cyclophosphamide myeloablation: A retrospective, multicenter analysis. Bone Marrow Transplant 18: 171-176, 1996
18. Cutler C, Li S, Kim H-S, et al: Oral mucositis incidence and severity after methotrexate and non-methotrexate containing GVHD prophylaxis. Blood 104:104a, 2004 (suppl 1; abstr 351)
19. Bacigalupo A, Vignola M, Lamparelli T, et al: Long term follow up of two randomized trials on antithymocyte globulin (ATG) for GvHD prophylaxis in unrelated donor transplants: Chronic GvHD, bronchiolitis and quality of life. Blood 104:128a, 2004 (suppl 1; abstr 638)
20. Chakraverty R, Peggs K, Chopra R, et al: Limiting transplantation-related mortality following unrelated donor stem cell transplantation by using a nonmyeloablative conditioning regimen. Blood 99:1071-1078, 2002
21. Kottaridis PD, Milligan DW, Chopra R, et al: In vivo CAMPATH-1H prevents graft-versus-host disease following nonmyeloablative stem cell transplantation. Blood 96:2419-2425, 2000
22. Morris E, Thomson K, Craddock C, et al: Outcome following alemtuzumab (CAMPATH-1H)-containing reduced intensity allogeneic transplant regimen for relapsed and refractory non-Hodgkin's lymphoma (NHL). Blood 104:3865-3871, 2004
23. Greenberg P, Cox C, LeBeau MM, et al: International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 89: 2079-2088, 1997
24. Charlson M, Szatrowski TP, Peterson J, et al: Validation of a combined comorbidity index. J Clin Epidemiol 47:1245-1251, 1994
25. Verma A, Devine S, Morrow M, et al: Low incidence of CMV viremia and disease after allogeneic peripheral blood stem cell transplantation: Role of pretransplant ganciclovir and post-transplant acyclovir. Bone Marrow Transplant 31:813-816, 2003
26. Ljungman P, De la Camara R, Milpied N, et al: Randomized study of valacyclovir as prophylaxis against cytomegalovirus reactivation in recipients of allogeneic bone marrow transplants. Blood 99:3050-3056, 2002
27. Nichols WG, Price TH, Gooley T, et al: Transfusion-transmitted cytomegalovirus infection after receipt of leukoreduced blood products. Blood 101:4195-4200, 2003
28. Przepiorka D, Weisdorf D, Martin P, et al: Consensus conference on GVHD grading. Bone Marrow Transplant 15:825-828, 1995
29. Bartholomew A, Sher D, Sosler S, et al: Stem cell transplantation eliminates alloantibody in a highly sensitized patient. Transplantation 72:1653-1655, 2001
30. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
31. Gooley TA, Leisenring W, Crowley J, et al: Estimation of failure probabilities in the presence of competing risks: New representations of old estimators. Stat Med 18:695-706, 1999
32. Chappell R: Letter to the editor. Int J Radiat Oncol Biol Phys 36:988-989, 1996
33. Klein JP, Rizzo JD, Zhang MJ, et al: Statistical methods for the analysis and presentation of the results of bone marrow transplants. Part I: Unadjusted analysis. Bone Marrow Transplant 28:909-915, 2001
34. van Besien K, Smith S, Anastasi J, et al: Irreversible myelosuppression after fludarabine-melphalan conditioning: Observations in patients with graft rejection. Blood 103:4373-4374, 2004
35. Wingard JR, Leather H: A new era of antifungal therapy. Biol Blood Marrow Transplant 10:73-90, 2004
36. Boeckh M, Nichols WG, Papanicolaou G, et al: Cytomegalovirus in hematopoietic stem cell transplant recipients: Current status, known challenges, and future strategies. Biol Blood Marrow Transplant 9:543-558, 2003
37. Slavin S, Nagler A, Naparstek E, et al: Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and non-malignant hematologic diseases. Blood 91:756-763, 1998
38. Giralt S, Thall PF, Khouri I, I, et al: Melphalan and purine analog-containing preparative regimens: Reduced- intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation. Blood 97:631-637, 2001
39. Hale G, Zhang MJ, Bunjes D, et al: Improving the outcome of bone marrow transplantation by using CD52 monoclonal antibodies to prevent graft-versus-host disease and graft rejection. Blood 92:4581-4590, 1998
40. Avivi I, Chakrabarti S, Milligan DW, et al: Incidence and outcome of adenovirus disease in transplant recipients after reduced-intensity conditioning with alemtuzumab. Biol Blood Marrow Transplant 10:186-194, 2004
41. Chakrabarti S, Mackinnon S, Chopra R, et al: High incidence of cytomegalovirus infection after nonmyeloablative stem cell transplantation: Potential role of Campath-1H in delaying immune reconstitution. Blood 99:4357-4363, 2002
42. Kline J, Pollyea D, Larson RA, et al: Ganciclovir and high-dose valacyclovir prevent cytomegalovirus reactivation in patients receiving allogeneic stem cell transplants with Campath-1H based conditioning regimens. Biol Blood Marrow Transplant 11:94, 2005 (suppl 1; abstr 277)
43. Chalandon Y, Halter J, Guengoer T, et al: Impact of molecular HLA-matching for allogeneic transplantation from unrelated donors. Blood 104:280a, 2004 (abstr 979)
44. Fillion A, Loiseau P, Rocha V, et al: Decreased transplant related mortality and better survival in HLA matched (12/12 A, B, C, DRB1, DQB1, DBP1) unrelated bone marrow transplants. Blood 104:280a, 2004 (abstr 977)
45. Yakoub-Agha I, Boiron J-M, Michallet M, et al: Genoidentical donor versus A, B, Cw, Dr, DQ, HLA allelic matched unrelated donor for stem cell transplantation in patients with standard risk hematological malignancy. Blood 104: 279a, 2004 (abstr 976)
46. Pollyea D, Artz AS, Stock W, et al: Clinical predictors of transplant related mortality after reduced intensity allogeneic hematopoietic transplantation. Blood 104:324a, 2004 (abstr 1145)
47. Deeg HJ, Appelbaum FR, Storer B, et al. Reduced incidence of acute and chronic graft-versus-host disease (GvHD) without increased relapse in patients with high-risk myeloid disorders given thymoglobulin (THY) as part of the transplant conditioning regimen: A dose-finding study. Blood 104:569a, 2004 (abstr 181)
48. Papadopoulos EB, Carabasi MH, Castro-Malaspina H, et al: T-cell-depleted allogeneic bone marrow transplantation as postremission therapy for acute myelogenous leukemia: Freedom from relapse in the absence of graft-versus-host disease. Blood 91:1083-1090, 1998
49. Soiffer RJ, Fairclough D, Robertson M, et al: CD6-depleted allogeneic bone marrow transplantation for acute leukemia in first complete remission. Blood 89:3039-3047, 1997
50. Aversa F, Terenzi A, Carotti A, et al: Improved outcome with T-cell-depleted bone marrow transplantation for acute leukemia. J Clin Oncol 17:1545-1550, 1999
51. Marks DI, Bird JM, Vettenranta K, et al: T cell-depleted unrelated donor bone marrow transplantation for acute myeloid leukemia. Biol Blood Marrow Transplant 6:646-653, 2000
52. Chakrabarti S, Marks DI: Should we T cell deplete sibling grafts for acute myeloid leukaemia in first remission? Bone Marrow Transplant 32:1039-1050, 2003
53. de Lima M, Couriel D, Thall PF, et al: Once-daily intravenous busulfan and fludarabine: Clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood 104:857-864, 2004
54. Sierra J, Storer B, Hansen JA, et al: Transplantation of marrow cells from unrelated donors for treatment of high-risk acute leukemia: The effect of leukemic burden, donor HLA matching, and marrow cell dose. Blood 89:4226-4235, 1997
55. Kebriaei P, Kline J, Stock W, et al: Impact of disease burden at time of allogeneic stem cell transplantation in adults with acute myeloid leukemia and myelodysplastic syndromes. Bone Marrow Transplant 35:965-970, 2005