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1 Navelstrengbloed tegen kanker THERAPIEDAG 2008: "Zorgtrajecten in kanker" Zaterdag 27 september 2008 Gasthuisberg, Leuven. Hélène Schoemans, MD KUL, Stem Cell Institute Leuven

2 Cord blood Collection and Banking 60%- 90%

3 Main Allogeneic HSCT indications in Europe Non-Malignant (Solid Tumors) Lymphoma Leukemia Gratwohl and Nierderweiser, BMT 2008

4 Ljungman and Apperley, BMT 2006

5 Ljungman and Apperley, BMT 2006

6 Belgian Data (KUL Donor Search) No donor found 34% Matched Unrelated Donor 26% Sibling Donor 40% median search time/patient 62 days to find a SIBLING 46 days to find a MUD 98 days All allogeneous BMT donor searches (outcomes per patient) until (n=88)

7 Pubmed Data Haplo Identical Donor Matched Unrelated Donor (MUD) HLA- A HLA- B HLA- DRB1 Cordblood Sibling Donor Laughlin NMDP Satellite Symposium ASH 2004 Sanz M, NEJM 2004; 351 (22):

8 Finding a unit million BM donors vs UCB banked % chance of finding one 5/6 to 6/6 matched donor 99% chance of finding one 4/6 matched unit If affordable... this donor is immediately available. Barker, BBMT 2002 Stevens, ASH 2005

9 What you get, is all you get... ONE SHOT quantity Slower engraftment No Donor Recall No DLI

10 Taking risks Graft rejection......and Host rejection Acute Graft versus Host disease (agvhd) Chronic Graft versus Host disease (cgvhd)

11 Evolution of HSC transplantation Adults 10% adult tx NMDP, ASBMT 2008

12 Cord vs Unrelated matched BMT 2.5 x10 (in adults) 7 TNC cells/kg Barker, BBMT2006 Laughlin, NEJM 2004 Rocha, NEJM 2004 Takahashi, Blood 2004 Cord BM Cord BM Cord BM Number of patients mismatch mismatch mismatch >= 3 mismatch TNCx 10 7 /kg 2,2 24 2,3 29 2,5 33 Time to neutrophile engraftment (days) Graft failure 27 NA > > NA 20% 7% 8% Acute GVHD II-IV 41% 48% 26%* 39% 50% 67% > Chronic GVHD 51%* 34% 30% 46% 75% 74% > < 18 1% Median Disease free survival % 23%* (3yr KM) 33% (3yr KM) 33% (2yr KM) 38% (2yr KM) 74%* (2yr KM) 44% (1yr KM) CB [= BM (5/6) ] < BM (6/6) CB = BM (6/6) CB > BM (6/6)

13 Evolution of HSC transplantation Children 41% ped tx NMDP, ASBMT 2008

14 Cord Blood Transplantation in Children Meta analysis Chronic GVHD Acute GVHD OVERALL SURVIVAL Khee et al, BMT 2007

15 Cord Blood Transplantation in Children with Acute Leukemia RETROSPECTIVE STUDY Kurtzberg, Blood 2008 Cord Number of patients mismatch 9 1 mismatch 30 2 mismatch 58 >= 3 mismatch 3 TNCx 10 7 /kg 5,1 Time to neutrophile engraftment (days) Graft failure 27 21pt/193pt Acute GVHD II-IV 42% Chronic GVHD 21% PROSPECTIVE STUDY Median Disease free survival % 50% (2yr KM) Eapen et al., Lancet 2007

16 Cord Blood: The Challenge Promising because of low GVHD and rapid availability Major drawback is the limited cell dose Probablility of death CD 34 + cells infused (x10 6 /kilogram recipient body weight) Wagner et al, Blood 2002

17 Solution 1: Double Cord Transplantation Combined cell dose: > 3.0 x 10 7 NC/kg CB 1 4/6 4/6 CB 2 Min 1.5 x10 7 cells/kg 4/6 Min 1.5 x10 7 cells/kg HLA A and B (Low Resolution*), DRB1 (High Resolution)

18 Double Cord Transplantation: The Evidence 3,7 x10 7 TNC cells/kg Barker 2005 Kai 2004 Ballen 2007 Brunstein 2007 DOUBLE unit only FULL Tx DOUBLE unit only FULL Tx DOUBLE unit only RIC Tx SINGLE (15%) and DOUBLE (85%) RIC Tx Number of patients TNC (x107/kg weight) 4.8 ( ) 3.9 ( ) 4.0 ( ) 3.7 ( ) Time to neutrophile engraftment (days) Graft failure/secondary Graft rejection 23 (15-41) 21 (16-26) 20 (15-34) 12 (0-32) 0% 2/11 pt 3 pt (14%) 15% Acute GVHD (II-IV) 65% (42-88)* 4/9 pt 4 pt (21%) 59% (49-69)* Chronic GVHD 23% (6-40)* 4/6 pt 3/12 pt (25%) 23 % (15-31)* Median follow up (months) 10 (3.5-30) (3-16) 7 (2-16) 14 ( ) TRM (% Cum. D % (5-39)* 2/11 pt 14% 19% (12-26)* 1-Year Overall survival (Kaplan Meier) 57% (35-79)* (DFS) 9/11 pt 71% (64% DFS) 38% at 3 years * = 95% confidence interval

19 Double Cord Transplantation: Kinetics of engraftment ² ² D+0 D+42 D+60 Barker, Blood 2005 (FULL conditionning) At D+42 (n=21): 100% engraftment 16pt (76%) engraftment from one unit 5pt (24%) engraftment from BOTH donors with one predominating unit. At D+60: 2pts double chimerism At D+100: 100% single chimerism D+100 Once engraftment was derived from one unit, the other unit never contributed to hematopoiesis

20 Double Cord Transplantation: Winner unit selection Viability? NO Level of HLA match? NO Location of HLA mismatch? NO ABO group? NO Sex match? NO CD3+ content of unit? NO Median infused cell dose (TNC, CD34+)? Yes/No In vitro differentiation performance (GM-CFU)? Order of infusion? Yes if more than 4h NK cell reactivity?

21 Double Cord Blood Transplants Is it just more? Or better? Single vs double retrospective studies yield largely inconclusive data... Time factor Regimen changed ATG Fludarabine CSA-MP CSA-MMF...

22 Brunstein and Wagner, Blood 2007 Double Better Event free survival Single Randomised study under way in pediatric population Double Single Similar Overall survival

23 Solution II: Ex-vivo Expansion or Shpall, 2002 UCB Day 0 Day 10 time Jaroscak, 2003

24 Ex-vivo Expansion Engraftment kinetics unchanged Expansion protocols have not yet expanded true HSC

25 Solution III: Co-infusion of PBSC Single CB unit + Highly purified, T-cell depleted PBSC from a haploidentical-related donor. Early engraftment (D10) despite myeloablative conditioning!... but ¾ pts w/agvhd 40% survival at 2 years. Magro, Haematologica 2006

26 Solution IV: Reduced Intensity Transplantation FULL RISICO: post-tx aplasie + infectie Mini of Reduced RISICO: post-tx rejectie + recidief I-S

27 Reduced Intensity Cord Blood Transplantation Chao 2004 Narimatsu 2005 Tashiro 2005 Hamaki 2005 Rio 2005 Brunstein 2007 Barker 2003 Ballen 2007 SINGLE unit SINGLE unit SINGLE unit SINGLE unit SINGLE unit SINGLE and DOUBLE unit SINGLE and DOUBLE unit DOUBLE unit Number of patients Age (years) 49 (19-62) 55 (17-79) (30-76) 48 (20-69) 50 (18-64) 49 (22-65) 49 (24-63) TNC (x107/kg weight) 2.1 ( ) 2.8 ( ) Not Av. Not Av. 3.4 ( ) 3.7 ( ) 3.3 ( ) 4.0 ( ) Time to neutrophile engraftment (days) Graft failure/secondary Graft rejection 12 (6-34) 20 (10-53) (11-33) 14 (1-28) 12 (0-32) 26 (12-30) 20 (15-34) 8/12 pt (67%) 9/123 pt 32% 6/16 pt 2/24 pt 15% 4 pt (22%) 3 pt (14%) Acute GVHD II-IV 2/5 pt 37% ( )* Not Av. 9 pt 20% +/- 8% 59% (49-69)* 44% (28-62)* 4 pt (21%) Chronic GVHD 1pt 26% Not Av. Not Av. 7/17 pts 23 % (15-31)* 21% (8-34)* 3/12 pt (25%) 1-Year Overall survival (Kaplan Meier) 43% 32% ( )* Not Av. Not Av. Not Av. 38% at 3 years 31% (15-47)* 71% Relapse/Progression (% Cum Incid) Not Av. Not Av. Not Av. Not Av. 3 pt 31% (21-41%) DFS at 1 year: 24% DFS * = 95% confidence interval

28 CB Banking : public or private The real question is......who should pay for CB banking? - Low clinical evidence for other indications than cancer - Statistical chance of using UCB for autotx is 1/ Pre-leukemia clone could present Cannot cure inherited disorders Over the last 15 years, only 3 single case reports published with commercial UCB. Sullivan, Nature Reviews 2008

29 DCB Directed UCB Donation English pregnant w/ current or family history of patient with disease that could benefit from HSCT 10yrs = 268 collections 30% compatible with affected patient 5% actually used for transplant (10 for congenital anemia, 3 for ALL) Smythe and Watt, Stem Cells 2007

30

31 Take Home Message Cord blood transplantation is an attractive alternative solution, to be done responsibly in the context of clinical protocols, because of availablility and low GVHD. The common denominator of clinical research at this point is increasing cell dose and/or reducing TRM. Banking is important to diversify HLA offer and provide material for research.

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