Pr Eliane Gluckman, MD, FRCP, Disclosure of Interest: Nothing to Disclose

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1 Pr Eliane Gluckman, MD, FRCP, Hospital Saint Louis, University Paris- Diderot, France Should Haplo-identical transplantation be preferred to cord blood in patients without a matched donor? Disclosure of Interest: Nothing to Disclose

2 Why do we ask the question? Unrelated cord blood transplant is clinically validated and reproducible with numerous single center and registry based studies Haplo-related transplants have been pionneered in the 7s, but most results were provided by single centers and few large series are published New technologies have been recently introduced with promising results

3 The ideal stem cell source Immediate availability Few HLA restriction Absence of risk for the donor Applicable to all diseases and all ages Associated with rapid lympho hematopoietic recovery, potent graft versus malignancy effect, little risk of acute and chronic GVH and high disease free survival

4 Cord blood transplantation advantages More than 25 years experience High quality cord blood banks: Immediate availability, absence of donor risk, HLA mismatch accepted General applicability for children and adults with malignant and non malignant disorders Outcome data collection through international registries Survival outcomes comparable to other sources of stem cells Use extended in older populations with reduced intensity conditioning and double cord blood transplant Exciting new results for improving engraftment and immune reconstitution

5 Past and Present of Cord Blood Transplants 1988 First Cord Blood Transplant Establishment of Cord Blood Banks (NY, Paris, Milan and Dusseldorf ) 1995 Establishment of Eurocord group 1998 Large series of UCBT= cell dose and HLA 22 Use of cord blood cells in adults with promising results 26 More adults than children transplanted with cord blood cells 28 Allele matched UBMT compared to UCBT 21 HLA C typing and outcomes 213 HLA allele level typing

6 Number of stem cell donors and cord blood units worldwide Total donors: 22,387,367 21,798,49 stem cell donors 588,958 CBU s Data from BMDW - Bone Marrow Donors Worldwide

7 Eurocord Database 159 cord blood transplantations were performed from 1988 to September 213 in 52 countries and 58 centres 298 EBMT 7745 cases (74%) 282 Non-EBMT 2764 cases (24%) related n=765 unrelated n=9699 children (age<18y) n=5556 adult n=484 7% 53% 47% 93%

8 Related and Unrelated UCBT in Children and Adults per Year Eurocord, n=8667 CIBMTR, n= Adult, n=422 7 Adult, n=419 5 Children, n= Children, n=

9 Single and double UCBT: distribution of age for adult patients >6 y 5-59 y 4-49 y % adults>5 years y 16-3 y Eurocord CIBMTR

10 Unrelated UCBT performed in EBMT centers by recipient s age and graft type Single Double Of the 6162 unrelated UCBT performed from 199 to 212, 74% used a Single CB and 26%, double CBUs Single UCBT was used in 92% of transplants in children and 54% in adults 35 Children (<18 years) n=3267 Single UCBT, n=32 Double UCBT, n= Adults n=2888 Single UCBT, n=1549 Double UCBT, n=

11 Type of conditioning for unrelated UCBT performed in EBMT centers Children (<18 years) n= 364 MAC, n= 2471 RIC, n= 593 Adults n= 2788 MAC, n= 1337 RIC, n= MAC RIC

12 Transplants by diagnosis Children Adults 11% 9% 3% 47% 14% 3% 3% 1% 7% 59% 11% 2% 1% 2% Acute leukemia MDS / MPD Lymphomas / Solid tumors Bone Marrow Failure Sd Hemoglobinopathy Immune Deficiency Metabolic Disorder Histiocytosis / Others Acute leukemia MDS /MPD Lymphomas Plasma cell disorders / Solid tumors Bone Marrow Failure Sd Other non malignant disorders

13 Single and Double UCBT in EBMT centers, n=3237 Children: 2-y OS according to disease Malignant: 5± 1%; n=1159 Non-malignant: 63 ± 2%; n=1113 P<.1

14 Single and Double UCBT in EBMT centers: AML, ALL, MDS Children: 2-y OS (N=17) 2-25 (N=555) years years years 37±4% p<.1

15 Single and Double UCBT in EBMT centers, n=2768 Adult, 2-y OS according to disease: MDS/MPS: 25± 3%; n=38 Plasma cell disorder : 44 ± 6%; n=94 Lymphoma : 44 ± 3%; n=329 Acute leukemia 38 ± 2%; n=1685 Chronic leukemia 4 ± 3%; n=268 p=.17

16 New clinical developments Single versus double UCBT New conditioning Criteria of donor choice Ex vivo expansion

17 Adjusted Probability, % Overall Survival - Adequate Dose Single vs. Double UCBT HR.92, p= Double UCBT, 32% Single UCBT, TNC 2.5 x 1 7 /kg, 33% Months Scaradavou ; Blood 213

18 2 years- LFS after MAC sucbt and ducbt in adults with AL in CR1, n=239 Group 3: ducbt-cyflutbi12: 48±6%, n=83 Group 2: sucbt-buflutt+atg: 46±6%, n=88 Group 1: sucbt-cytbi12: 3±7%, n=68 p=.3 Ruggeri ; Leukemia 213

19 2 years- LFS after RIC sucbt and ducbt in adults with AL in CR1, n=212 ducbt, n= ± 5% sucbt, n=76 32 ± 3% p=.3 In multivariate analysis, double CBT was associated with improved LFS rates [p=.4 HR=.64 ( )] Rocha ; ASH 212

20 Criteria of donor choice

21 Lesser vs. Allele-level HLA-match 3/8 4/8 5/8 6/8 7/8 8/8 4/6 11% 31% 49% 1% 5/6 1% 8% 22% 44% 25% 6/6 4% 18% 24% 54% Eapen, EBMT 213

22 Incidence, % Neutrophil Recovery - Allele-level Matched at A, B, C, DRB P=.5 6/8 (66%) 8 6 7/8 (62%) 6 4 8/8 (71%) 3/8 (53%) 4 2 4/8 (56%) 2 5/8 (58%) Days Eapen, EBMT 213

23 Odds Ratio Neutrophil Recovery - Allele-level Matched at A, B, C, DRB P= /8 6/8 5/8 4/8 3/8. HLA-Match Eapen, EBMT 213

24 Incidence, % Non-Relapse Mortality - Allele-level Matched at A, B, C, DRB P< /8 (37%) 5/8 (34%) 6 4 6/8 (26%) 3/8 (41%) 4 2 7/8 (26%) Years 8/8 (9%) Eapen, EBMT 213

25 Hazard Ratio Non-Relapse Mortality - Allele-level Matched at A, B, C, DRB P< /8 6/8 5/8 4/8 3/ HLA-Match Eapen, EBMT 213

26 Eapen, EBMT 213 RISK FACTORS - HIGHER MORTALITY Factors Non Relapse Mortality Overall Mortality Age, > 16 years HR 1.62 HR 1.43 ALL HR 1.35 HR 1.26 Active disease at transplant HR 1.68 HR 2.98 TNC 3 x 1 7 /kg HR 1.51 HR 1.35 Period 2-24 HR 1.51 HR 1.35

27 Incidence, % Non-Relapse Mortality - 7/8 Allele-level HLA-Matched: Effect of TNC /8, TNC 3 x 1 7 /kg (45%) /8, TNC> 5 x 1 7 /kg (2%) 7/8, TNC > 3 5 x 1 7 /kg (24%) 8/8 (9%) Years 2 Eapen, EBMT 213

28 Eapen, EBMT 213 Non-Relapse Mortality - Effect of mismatch at single HLA-locus - HR P-value HLA-A match vs. mismatch 117 vs. 117 HLA-B match vs. mismatch 31 vs. 117 HLA-C match vs. mismatch 4 vs. 117 HLA-DRB1 match vs. mismatch 66 vs

29 Eapen, EBMT 213 Select units with TNC 3 x 1 7 /kg Best HLA-match Allele-level match at HLA-A, -B, -C and DRB1 Avoid 3/8 HLAmatched transplants Absence of HLA-C typing match at HLA-B HLA-C at confirmatory typing 7/8 and 6/8 are better tolerated than 5/8 or 4/8 HLA-matched transplants TNC in excess of minimum required does not lower NRM

30 Comparative Studies of cord blood transplant with other stem cell sources

31 Adjusted Probability, % Survival and LFS are similar after UCBT compared to unrelated bone marrow in children with acute leukemias 1 8 CB matched (n=35) 6% CB 1-Ag MM >3.5x1 7 /kg (n=157) 45% BM matched (n=116) 38% CB 2-Ag MM (n=267) 33% CB 1-Ag MM >3.5x17/kg (n=44) 35% Eapen M et al Lancet. 27, 369:

32 Probability, % Impact of Stem Cell Source in Adults with Acute Leukemia, n= Leukemia-free Survival -Adjusted for Disease Status at Transplantation BM matched, 41% PBPC matched, 39% CB, 33% Matched BM vs. CB RR.87, p=.254 Matched PBPB vs. CB RR.89, p=.177 Not in remission at HCT, RR 2.4, p< Years Eapen M, Rocha V, Lancet Onc 21

33 Cumulative Proportion 1..8 I I Leukemia-Free Survival by Donor Type Minnesota FHRC study I I I I I I I I I I I I I I I I I I I I MM URD DUCB SIB MUD I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I Years post-transplantation Matched Sibling* MUD MMUD DUCB ( ) 1.4 ( ) 1. ( ) P=.2 P=.85 P=.99 Brunstein C, Blood 21

34 Probability, % RIC Leukemia-Free Survival MUD vs. dcb other.68 (.47.99) P= dcb, TCF: 26% MUD: 31% MMUD: 25% dcb, other: 9% Months Brunstein C, Eapen M, Blood 212

35 Similarities between UCBT and haplo identical related transplant Cord blood Haplo identical HLA mismatch,1,2 mismatches 2,3 mismatches Availability 15-3 days 15-3 days GVHD limited limited Immune reconstitution Delayed Delayed Indications Malignant and non malignant Malignant and non malignant Age Children and adults Children and adults Conditioning Myeloablative or non myeloablative Myeloablative or non myeloablative

36 Differences between UCBT and haplorelated BMT UCBT Haplo Type of graft Cryopreserved cord blood Mobilized PBSC and or BM Limitation of Graft acquisition Cell dose Poor mobilization Graft manipulation None None or In vitro T cell depletion Donor safety No problem G-CSF toxicity + harvest Cell dose TNC CD34 T lymphocytes >.3x1 8 /kg >.2x1 6 /kg >.4x1 7 /kg >9x1 8 /kg >7x1 6/ kg varies GVH prophylaxis Standard Standard +in vivo T cell depletion or non for T depleted Cost of the graft 2-3, US $ Cost of G-CSF, graft harvest and manipulation

37 Controversies-UCBT Sustainability and quality of cord blood banks UCBT is associated with delayed engraftment and immune reconstitution No possibility to perform DLI, but GVL after UCBT is high and immunotherapy is possible

38 Controversies-Haplo Criteria of donor choice Indications and conditioning: small series, heterogeneity Stem cell source GCSF primed BM or PBSC or both Effect of cell dose and graft composition T deplete or not? GVHD prophylaxis None Post HSCT cyclophosphamide, rapamycin, multi drugs (ATG + MTX + CSA + MMF + basiliximab) Single center experience : Outcome data and long term follow up are not yet available

39 Conclusion HLA mismatched HSCT transplants are feasible and there is no shortage of donors Is MUD=CB=Haplo? All retrospective studies in children and adults with acute leukemia showed that alternative sources such as UBMT, UCBT or Haplo, can be used to treat a number of patients with some different outcomes, but similar LFS Comparative registry-based studies are needed Collaborative protocols should explore new methods to improve results The ultimate choice of the SC source depends on expertise and policy of each center

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