Fludarabine and 2-Gy TBI is superior to 2Gy TBI as conditioning for HLA-Matched related hematopoietic cell transplantation: A phase III randomized trial

Biology of Blood and Marrow Transplantation

Volumn 19, Issue 9, 2013, Pages 1340-1347

  Kornblit, Brian ^a   Maloney, David G ^a,b   Storb, Rainer ^a,b   Storek, Jan ^c   Hari, Parameswaran ^d   Vucinic, Vladan ^e   Maziarz, Richard T ^f   Chauncey, Thomas R ^a,g   Pulsipher, Michael A ^h   Bruno, Benedetto ⁱ   Petersen, Finn B ^j   Bethge, Wolfgang A ^k   Hübel, Kai ^l   Bouvier, Michelle E ^a   Fukuda, Takahiro ^m   Storer, Barry E ^a,n   Sandmaier, Brenda M ^a,b  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALGARY   (Canada)

^d MEDICAL COLLEGE OF WISCONSIN   (United States)

^e UNIVERSITY OF LEIPZIG   (Germany)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g VA PUGET SOUND HEALTH CARE SYSTEM   (United States)

^h UNIVERSITY OF UTAH   (United States)

ⁱ UNIVERSITY OF TURIN   (Italy)

^j LDS HOSPITAL   (United States)

^k UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^l UNIVERSITY OF COLOGNE   (Germany)

^m NATIONAL CANCER CENTER HOSPITAL   (Japan)

ⁿ UNIVERSITY OF WASHINGTON   (United States)

more..

Author keywords

Body irradiation; Fludarabine low dose total; Hematopoietic cell; HLA matched related; Nonmyeloablative conditioning; Transplantation randomized; Trial

Indexed keywords

ANTINEOPLASTIC AGENT; CYCLOPHOSPHAMIDE; FLUDARABINE; RITUXIMAB; HLA ANTIGEN; VIDARABINE;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; AGED; ALLELE; ARTICLE; CANCER SURVIVAL; CHIMERA; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CONTROLLED STUDY; FEMALE; GRAFT VERSUS HOST REACTION; HAPLOTYPE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HODGKIN DISEASE; HUMAN; IMMUNOPHENOTYPING; MALE; MANTLE CELL LYMPHOMA; MULTICENTER STUDY; MULTIPLE MYELOMA; MYELODYSPLASTIC SYNDROME; MYELOPROLIFERATIVE DISORDER; NONHODGKIN LYMPHOMA; NONMYELOABLATIVE CONDITIONING; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; PROLYMPHOCYTIC LEUKEMIA; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; SEPSIS; T LYMPHOCYTE; WHOLE BODY RADIATION; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; GENETICS; IMMUNOSUPPRESSIVE TREATMENT; METABOLISM; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PROCEDURES; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC AGENTS; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HLA ANTIGENS; HUMANS; IMMUNOPHENOTYPING; MALE; MIDDLE AGED; TRANSPLANTATION CONDITIONING; VIDARABINE; WHOLE-BODY IRRADIATION; YOUNG ADULT;

EID: 84882781560     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2013.06.002     Document Type: Article

References (36)

1. Storb R., Raff R.F., Appelbaum F.R., et al. Comparison of fractionated to single-dose total body irradiation in conditioning canine littermates for DLA-identical marrow grafts. Blood 1989, 74:1139-1143.
2. Storb R., Yu C., Wagner J.L., et al. Stable mixed hematopoietic chimerism in DLA-identical littermate dogs given sublethal total body irradiation before and pharmacological immunosuppression after marrow transplantation. Blood 1997, 89:3048-3054.
3. Storb R., Raff R.F., Graham T., et al. Marrow toxicity of fractionated versus single dose total body irradiation is identical in a canine model. Int J Radiat Oncol Biol Phys 1993, 26:275-283.
4. McSweeney P.A., Niederwieser D., Shizuru J.A., et al. Hematopoietic cell transplantation in older patients with hematologic malignancies: replacing high-dose cytotoxic therapy with graft-versus-tumor effects. Blood 2001, 97:3390-3400.
5. Sandmaier B.M., Maloney D.G., Gooley T.A., et al. Low dose TBI conditioning for hematopoietic stem cell transplants (HSCT) from HLA-matched related donors for patients with hematologic malignancies: influence of fludarabine or cytoreductive autografts on outcome. Blood 2002, 100. (Part 1):145a, #544[abstr.].
6. Panse J.P., Heimfeld S., Guthrie K.A., et al. Allogeneic peripheral blood stem cell graft composition affects early T cell chimaerism and later clinical outcomes after nonmyeloablative conditioning. Br J Haematol 2005, 128:659-667.
7. Petersdorf E.W., Gooley T.A., Anasetti C., et al. Optimizing outcome after unrelated marrow transplantation by comprehensive matching of HLA class I and II alleles in the donor and recipient. Blood 1998, 92:3515-3520.
8. Maris M.B., Niederwieser D., Sandmaier B.M., et al. HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative conditioning for patients with hematologic malignancies. Blood 2003, 102:2021-2030.
9. The Revised Common Toxicity Criteria: Version 2.0. DCTD, NCI, NIH, DHHS,1999.
10. Junghanss C., Marr K.A., Carter R.A., et al. Incidence and outcome of bacterial and fungal infections following nonmyeloablative compared with myeloablative allogeneic hematopoietic stem cell transplantation: a matched control study. Biol Blood Marrow Transplant 2002, 8:512-520.
11. Przepiorka D., Weisdorf D., Martin P., et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant 1995, 15:825-828.
12. Sullivan K.M. Graft-versus-host disease. Hematopoietic Cell Transplantation 1999, 515-536. Blackwell Sciences, Inc., Malden, MA. E.D. Thomas, K.G. Blume, S.J. Forman (Eds.).
13. Storek J., Dawson M.A., Storer B., et al. Immune reconstitution after allogeneic marrow transplantation compared with blood stem cell transplantation. Blood 2001, 97:3380-3389.
14. Storek J., Zhao Z., Lin E., et al. Recovery from and consequences of severe iatrogenic lymphopenia (induced to treat autoimmune diseases). Clin Immunol 2004, 113:285-298.
15. Kahl C., Storer B.E., Sandmaier B.M., et al. Relapse risk among patients with malignant diseases given allogeneic hematopoietic cell transplantation after nonmyeloablative conditioning. Blood 2007, 110:2744-2748.
16. Sorror M.L., Maris M.B., Storb R., et al. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood 2005, 106:2912-2919.
17. Niederwieser D., Maris M., Shizuru J.A., et al. Low-dose total body irradiation (TBI) and fludarabine followed by hematopoietic cell transplantation (HCT) from HLA-matched or mismatched unrelated donors and postgrafting immunosuppression with cyclosporine and mycophenolate mofetil (MMF) can induce durable complete chimerism and sustained remissions in patients with hematological diseases. Blood 2003, 101:1620-1629.
18. Keil F., Prinz E., Moser K., et al. Rapid establishment of long-term culture-initiating cells of donor origin after nonmyeloablative allogeneic hematopoietic stem-cell transplantation, and significant prognostic impact of donor T-cell chimerism on stable engraftment and progression-free survival. Transplantation 2003, 76:230-236.
19. Baron F., Maris M.B., Sandmaier B.M., et al. Graft-versus-tumor effects after allogeneic hematopoietic cell transplantation with nonmyeloablative conditioning. JClin Oncol 2005, 23:1993-2003.
20. Baron F., Baker J.E., Storb R., et al. Kinetics of engraftment in patients with hematologic malignancies given allogeneic hematopoietic cell transplantation after nonmyeloablative conditioning. Blood 2004, 104:2254-2262.
21. Breuer S., Preuner S., Fritsch G., et al. Early recipient chimerism testing in the T- and NK-cell lineages for risk assessment of graft rejection in pediatric patients undergoing allogeneic stem cell transplantation. Leukemia 2012, 26:509-519.
22. Alyea E.P., Kim H.T., Ho V., et al. Impact of conditioning regimen intensity on outcome of allogeneic hematopoietic cell transplantation for advanced acute myelogenous leukemia and myelodysplastic syndrome. Biol Blood Marrow Transplant 2006, 12:1047-1055.
23. Khouri I.F., McLaughlin P., Saliba R.M., et al. Eight-year experience with allogeneic stem cell transplantation for relapsed follicular lymphoma after nonmyeloablative conditioning with fludarabine, cyclophosphamide, and rituximab. Blood 2008, 111:5530-5536.
24. Freytes C.O., Zhang M.J., Carreras J., et al. Outcome of lower-intensity allogeneic transplantation in non-Hodgkin lymphoma after autologous transplantation failure. Biol Blood Marrow Transplant 2012, 18:1255-1264.
25. Kolb H.J., Schmidt C., Barrett A.J., Schendel D.J. Graft-versus-leukemia reactions in allogeneic chimeras. Blood 2004, 103:767-776.
26. Parham P., McQueen K.L. Alloreactive killer cells: hindrance and help for haematopoietic transplants (Review). Nat Rev Immunol 2003, 3:108-122.
27. Baron F., Petersdorf E.W., Gooley T., et al. What is the role for donor NK cells after nonmyeolablative conditioning?. Biol Blood Marrow Transplant 2009, 15:580-588.
28. De B.M., Fillet M., Hannon M., et al. Kinetics of IL-7 and IL-15 levels after allogeneic peripheral blood stem cell transplantation following nonmyeloablative conditioning. PLoS ONE 2013, 8:e55876. [Electronic Resource]. 10.1371/journal.pone.0055876.
29. Keating M.J., O'Brien S., Lerner S., et al. Long-term follow-up of patients with chronic lymphocytic leukemia (CLL) receiving fludarabine regimens as initial therapy. Blood 1998, 92:1165-1171.
30. Ysebaert L., Gross E., Kuhlein E., et al. Immune recovery after fludarabine-cyclophosphamide-rituximab treatment in B-chronic lymphocytic leukemia: implication for maintenance immunotherapy. Leukemia 2010, 24:1310-1316.
31. Hari P., Carreras J., Zhang M.J., et al. Allogeneic transplants in follicular lymphoma: higher risk of disease progression after reduced-intensity compared to myeloablative conditioning. Biol Blood Marrow Transplant 2008, 14:236-245.
32. Ringdén O., Labopin M., Ehninger G., et al. Reduced intensity conditioning compared with myeloablative conditioning using unrelated donor transplants in patients with acute myeloid leukemia. JClin Oncol 2009, 27:4570-4577.
33. Dreger P., Brand R., Milligan D., et al. Reduced-intensity conditioning lowers treatment-related mortality of allogeneic stem cell transplantation for chronic lymphocytic leukemia: a population-matched analysis. Leukemia 2005, 19:1029-1033.
34. Michallet M., Socie G., Mohty M., et al. Rituximab, fludarabine, and total body irradiation as conditioning regimen before allogeneic hematopoietic stem cell transplantation for advanced chronic lymphocytic leukemia: long-term prospective multicenter study. Exp Hematol 2013, 41:127-133.
35. Takahashi K., Kantarjian H., Pemmaraju N., et al. Salvage therapy using FLT3 inhibitors may improve long-term outcome of relapsed or refractory AML in patients with FLT3-ITD. Br J Haematol 2013, 161:659-666.
36. Chen Y., Kornblit B., Hamlin D.K., et al. Durable donor engraftment after radioimmunotherapy using a-emitter astatine-211-labeled anti-CD45 antibody for conditioning in allogeneic hematopoietic cell transplantation. Blood 2012, 119:1130-1138.