Haploidentical Transplantation today: and the alternatives

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1 Haploidentical Transplantation today: and the alternatives Daniel Weisdorf MD University of Minnesota February, 2013

2 No matched sib: where to look? URD donor requires close HLA matching and 3-12 weeks for searching Unrelated donor UCB is validated: numerous published series & registry studies Haplo-identical related donor HCT were tested in 1970s but rarely performed due to: excess GVHD or prolonged immmunodeficiency New Haplo approaches are promising

3 UCB vs Haplo Similarities

4 Differences ~$40,000 per unit

5 >500,000 >18,000,000

6 UCB outcomes children

7 UCB outcomes adults

8

9

10

11 UCB Grafting: Adults AML CR1

12 Sources of Partial Matched Grafts Haploidentical relatives Parents or children Partially matched siblings; cousins G-CSF mobilized PBSC CD34+ selected G-CSF stimulated BM G-CSF mobilized CD34+ BM Unmanipulated BM Unmanipulated PBSC

13 Conditioning for Haplo Transplants Myeloablative TBI or Bu Cy ± Fludarabine Treosulfan or Thiotepa RIC TBI 200cGy Cy 50 mg/kg Fludarabine 40 mg/m2 x 4 GVHD prophylaxis T depleted graft + none CSA/Tac ± MMF± Mtx ATG Anti T or B monoclonal Abs Sirolimus + MMF or Tac Post-HCT cyclophosphamide

14 Limitations of Haploidentical Transplant Increased Alloreactivity Initial study at Marsden using unmanipulated marrow after TBI/Cy 10/35 with graft failure 12/35 died of hyperacute GVHD Powles et al Lancet 1983

15 Limitations of Haploidentical Transplant Increased Alloreactivity Early studies showed equivalent outcome for 5/6 donors Increased GVHD but also reduced relapse Poor outcomes for 3/6 and 4/6 donors with standard regimens Beatty et al NEJM 1985 Anasetti et al NEJM 1989

16 Haplo transplant Approaches *CD34+ selection Pathogen specific lymphocytes TK-transduced IL-10 anergized Photo-allodepleted CD8 negative Treg supplemented CD3-/CD19- CD3 (α/β) depleted Unmanipulated BM [or PBSC] *Cyclophosphamide day +3,+4 Basiliximab, CSA Sirolimus

17 Haplo Problems Cost Technical challenges for manipulations Delayed immune recovery Infections; Relapse Mortality Haplo Advantages Nearly universal Rapidly available Simple if unmanipulated Suicide T cells Ag specific T cells Tregs Specific T cell populations

18

19 Haplo HCT for High risk Adult Acute Leukemia: EBMT Ciceri, Blood 2006

20

21 TRAMM and Haplo Grafting

22 Intensive Immunosuppression 820 patients with hematologic malignancies received busulfan, cytarabine, cyclophosphamide, rabbit ATG Unmanipulated GCSF-stimulated bone marrow. GVHD prophylaxis with MMF, cyclosporine, MTX Grades II to IV acute GVHD 42.9% 3-year leukemia-free survival (LFS) 67.9% & 48.8% in standard-risk and high-risk groups Beijing Regimen Chang and Huang Curr Opin Hematol 2012

23 Intensive Immunosuppression Italian Study Unmanipulated, GCSF-primed BMT Neutrophil engraftment 93% Grade II-IV & III-IV acute GVHD 24% & 5% 3-year probability of DFS for standard-risk and high-risk patients 44% and 30% Di Bartolomeo et al Blood 2012

24 Current Haploidentical Regimens Intensive Immunosuppression Depletion alloreactive cells Post transplant Cyclophosphamide Anergization Megadose CD34-enriched cells CD34 selection T cell depletion

25 Post-Transplant Cyclophosphamide

26 Luznik, BBMT, 2008

27

28 Update RIC Haplo BMT Hopkins N=210 5 year outcomes 87% engraftment GVHD II-IV 27% cgvhd 13% Non-relapse mortality 18% Relapse 55% Survival 35% Event-free survival 27% Munchel, Pediatric Reports, 2011 Fuchs Curr Opin Hematol 2012 Age 52 (1-73) M:F 149:61 Ac Leukemia 59 Ch Leukemia 33 MDS/MPN 16 NHL/HL 66/30 MM 6 Donor Age 42 (14-73) Parents 35 Sib/half sib 102 Children 73

29 Munchel, Pediatric Reports, 2011

30 Update RIC Haplo BMT Hopkins Munchel, Pediatric Reports, 2011

31 Post Transplant Cyclophosphamide Benefits Easy to use Exportable to many centers Low non-relapse and infectious mortality Concerns Significant relapse rate

32 Treatment Regimens Minnesota Protocol (0604) Hopkins Protocol (0603)

33 BMT CTN: Parallel trials of RIC UCB and Haplo BM HCT for Heme malignancies Brunstein, Blood 2011

34 GVHD

35 BMT CTN: Parallel trials RIC HCT for Heme malignancies CTN-0604 Double UCB CTN-0603 Haplo-BM Brunstein, Blood, 2011

36 A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (ducb) versus HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematologic Malignancies BMT CTN PROTOCOL 1101 Patient 18 and 70 yrs. Acute leukemia or lymphoma Adequate organ function Performance score 70 Available both Double cord graft Haploidentical related donor Randomization Stratified by Transplant Center Primary Endpoint Progression-free survival at 2 yrs Secondary Endpoints Engraftment GVHD Relapse TRM Immune reconstitution Quality of Life Cost Effectiveness Double UCB Haplo-BM

37

38 Ex vivo T Cell Anergization Induction of alloantigen-specific anergy by co-culturing donor bone marrow and host irradiated PBMC with CTLA-4-IG (n=19) or anti B7.1 and B7.2 (n=5) Less than expected GVHD Low incidence infection and relapse 12/24 died of TRM Guinan et al NEJM 1999 Davies et al Blood 2008

39 Megadose CD34-selected cells GCSF stimulation donor followed by CD34 selection 3-4 log T cell depletion High engraftment (>95%) Low GVHD (<10%) 48% DFS in AML 46% DFS in ALL Aversa et al NEJM 1998 Aversa et al J Clin Oncol 2005

40 Baylor Pediatric DFS after CD34-selected Haploidentical Transplant for Hematologic Malignancy se % Years post transplant

41 Causes of Failure Relapse 21% Infection 22%

42 CD34 Selection Benefits Minimal GVHD Good engraftment Concerns More complex manufacturing (IND) Delayed immune recovery increases risk of infections Significant relapse rate

43 T Cell Depletion CD3 or CD3/19 depleted PBSC Pediatric series, selective T cell depletion has resulted in 2 year event free survival of 26-88% In adults resulted in survival at 1 and 2 years of 41 and 28% Handgretinger et al Curr Opin Hematology 2012 Federmann et al Haematologica 2012

44 Outcomes With Different Approaches Difficult to compare with selection bias in all studies CD34 selection more common in Europe, pediatrics and nonmalignant disease Intensive immunosuppression more common in China

45 In 2012 and beyond Nearly all will have a donor Sib URD UCB Haplo But situational choices Age Performance status Disease and risk *Center Expertise Urgency These should all influence these donor and graft choices

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