juliet n. barker, mbbs (hons), fracp associate attending director cord blood transplant program
DESCRIPTION
Optimising Cord Blood Unit Selection. -7. -6. -5. -4. -3. -2. -1. 0. 30. 100. CSA/ MMF. Juliet N. Barker, MBBS (Hons), FRACP Associate Attending Director Cord Blood Transplant Program Memorial Sloan-Kettering Cancer Center. Acknowledgements. MSKCC Staff of Adult and Pediatric - PowerPoint PPT PresentationTRANSCRIPT
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Juliet N. Barker, MBBS (Hons), FRACPAssociate Attending
Director Cord Blood Transplant ProgramMemorial Sloan-Kettering Cancer Center
Optimising Cord BloodUnit Selection
CSA/ MMF -3 -2 -1-4-7 -6 -5 30 1000
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Acknowledgements
U of Minnesota John E. Wagner
NYBCPablo Rubinstein
Cladd StevensMachi Scaradavou
MSKCC
Staff of Adult and Pediatric Transplant
Search: Courtney Byam, Rosanna FerranteDebbie Wells, Kathleen Doshi, Sinda LeeCytotherapy Lab: esp Allison Schaible
CB Research Staff: Marissa LubinAnne Marie Gonzales , Katie Evans
Cellular Immunology Lab: Kathy SmithMalcolm Moore
Machi ScaradavouNancy Kernan & Richard O’Reilly
Doris PonceMarcel van den Brink & Sergio Giralt
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What have we achieved?
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One Strategy to Improve Outcome By Augmenting Cell Dose: Use 2.
Barker et al, NEJM 2001, Blood 2003, Blood 2005
Retrospective studies suggest improved engraftment & GVL.
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Sibling typing →simultaneous URD & CB search
Suitable Sibling(match/ donor health)
Suitable URD (match/ availability):
Suitable CB Graft (match/ dose):
4-6/6 A,B antigen, DRB1 allele2 units: each > 2 x 107 NC/kg
Hi Dose Prep Midi or Mini (Unmodified)Children(Young adults)
Midi/ Mini + 10/10 donor
Hi Dose +TCD 9-10/10 donor
MSKCC Donor Algorithm
Donors identified for > 95% patients.
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-7 0 +100
High (< 50): Acute leuk/ MDS/ hi grade NHLMidi (< 70): AML/ ALL/ MDS/ CML/ NHL/ CLL (or Mel/ Flu for Hodgkins not in CR)Mini (< 70): Hodgkins in CR/ Indolent NHLs/ CLL
CB #2
CB #1
CBT Preps & Immune SuppressionHigh: Cy 120/ Flu 75/ TBI 1375 (or Clo/ Mel/ Thio if no TBI)Midi: Cy 50/ Flu 150/ Thio 10/ TBI 400 (or Mel 140/ Flu 150)Mini: Cy 50/ Flu 150/ TBI 200
GVHD prophy: CSA/ MMF
3 intensities, mainly Cy-Flu-TBI based, no ATG, no steroids.
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0 10 20 30 40
0.0
0.2
0.4
0.6
0.8
1.0
Days Post-Transplant
Cum
ulat
ive
Inci
denc
eAblative: 94%@ 25 days
NMA*: 96% @ 10 days
Neutrophil Engraftment after DCBT (n = 108) Median 41 yrs (range 6-69), high risk heme malignancies
* Early auto recovery –switched to sustained donor engraftment
Dahi, P., ASBMT 2012
High rates of sustained donor engraftment.
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Months Post-Transplant
Pro
gres
sion
-Fre
e Su
rviv
al
0 12 24 36 48 60
0.0
0.2
0.4
0.6
0.8
1.0
P = 0.573
MSK Allo Tx for Heme Malignancies 2005-2009: 2 Year PFS After Double-Unit CB vs RD vs URD Transplant
Ponce, BBMT 2011
2 Yr PFS after CBT: comparable to RD or URD transplant.
CB (n = 75)RD (n = 108)URD (n = 184)
Up-front TRM compensated by reduced late mortality
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Comparison of Donor-Recipient HLA-Match:CB (n = 75, 150 units) vs URD (n = 184)
CB grafts: marked HLA-disparity.
CD34+ cell dose also much lower: RD 7.9, URD 6.0, CB 0.09 ( p < 0.001).
0%
10%
20%
30%
40%
50%
60%
70%
10 Allele HLA Match
Perc
ent o
f Don
orsHLA-Match for CB units
. 6/6 (n=5): 4/10 - 9/10
. 5/6 (n=82): 4/10 - 9/10
. 4/6 (n=63): 2/10 - 7/10
2 3 4 5 6 7 8 9 10
CB URD P < 0.001
Ponce, BBMT 2011
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Time Post-Transplant (Months)
Dis
ease
-Fre
e Su
rviv
alAdults** (n = 52, median 41 yrs, range 16-69): 64%
Children* (n = 23, median 9 yrs, range 0.9-15): 78%
DCBT if Acute Leukemia & MDS/MPD: 2-yr DFS
Barker et al, ASH 2011
Low incidenceof relapse
(9% children, 6% adults) translates
to relatively high survival
rates.
Inf. TNC: * 3.3 + 2.6 ** 2.7 + 1.9
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Time Post-Transplant (Months)
Dis
ease
-Fre
e Su
rviv
al
Adults 16-69 yrs (n = 52): 64% (Europeans 62%, Non-Europeans 66% )
Children 0-15 yrs (n = 23): 78% (Europeans 86%, Non-Europeans 75%)
DCBT if Acute Leukemia & MDS/MPD: 2-yr DFS
No differencebetweenEuropean &non-Europeanpatients.
In multivariateanalysis onlyCMV serostatuswas significant.
Barker et al, ASH 2011
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Why are these results important?
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Best Matched URD & Best CB if Combined Search by Patient Ancestry (n = 525)
Best Donors Europeans(n = 341)
Non-Europeans(n = 184)
p
Best URD10/10 (n = 218) 180 (53%) 38 (21%) <0.0019/10 (n = 148) 99 (29%) 49 (27%)<8/10 (n = 159) 62 (18%) 97 (53%)Best CB5-6/6 (n = 401) 270 (79%) 131 (71%)4/6 (n = 90) 56 (16%) 34 (18%)No CB (n = 34) 15 (4%) 19 (10%)
Volunteer unrelated donors: poor HSC source for non-Europeans.
Barker et al 2010, BBMT
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NW E
urope
Eastern
Euro
pe
SouthEuro
pe
Mix:
Euro
peAsia
n
Africa
n
White
Hisp
anic
Middle
Eastern
Mix:
Non
Euro
pe0
10
20
30
40
50
60
70
80
No graft (n=26) CB (n=90)
URD (n=269)
Num
ber
of P
atie
nts
Barker et al 2010, BBMT
CB Extends Transplant Access to “Minorities”:URD vs CB vs No Graft by Ancestry (n = 385)
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URD (n=426) CB (n=137) No Graft (n=34)
NW Europe Asian
Eastern Europe African
Southern Europe White Hispanic
Europe Mix Middle Eastern
Non-Europe Mix
Updated Data, MSKCC 2012 (n = 597)
Greater than 50% of CBTs had non-European ancestry
25% 53% 76%
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• Immunosuppression: rejection/ GVHD• Supportive care: infection, bleeding, nutrition
-7 +28 +100 +180 +1 year0
• Conditioning: High, Midi , Mini
Patient Related Factors• Biology of Malignancy: determines need for hi dose prep vs
reliance on GVL• Patient Characteristics: age, extent of prior Rx, co-morbidities.
CB: Dose, match, qualityTransplant Related Factors
Variables that Determine Outcome
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How to Select Units?
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10957303650
CI o
f Tra
nspl
ant-
Rel
ated
Mor
talit
y
Years Post-Transplant
4/6 & TNC <2.5
4/6 & TNC ≥5.0
4/6 & TNC 2.5-4.9
5/6 & TNC 2.5-4.9
5/6 & TNC <2.5
5/6 & TNC ≥5.0
80
100
20
40
60
0 1 2 3
6/6 & all doses (mean TNC 4.4)
TRM by Combined TNC Dose & A,B Antigen, DRB1 Allele-Match1061 NYBC Single Unit Myeloablative CBT 1993-2006
Very high TRM if mismatch & low TNC
Barker et al, Blood 2010Lowest TRM: best HLA-match, not highest dose.
Lowest TRM: 6/6 match
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Implications for Unit Selection(applies to single unit CBT, may also apply to double)
• Biggest cell dose not necessarily the best. 6/6 units highly attractive (?cell dose threshold).• Sliding scale: more mismatch, greater required cell dose. Converse also true: match can compensate for low dose.
Implies:• Above a cell dose threshold best matched unit the best.• New measures needed if best unit is mismatched.
Barker, Blood 2010
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Additional factors to consider in unit selection -
revealed in investigation of double unit biology
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% CD34+ Cell
Viability
EngraftingUnit
(N=44)
Non-Engrafting
Unit (N=44)
<75%(N=16) 1 15
≥75%(N=72) 43 29
Engraftment in 44 Double Unit CBTs Engrafting with a Single Unit.
Using CD34+ viability threshold of 75% (mean-2SD), all but one (43/44) engrafting units had CD34+ viability >75% (p=0.0006)
OR Only 1/16 poor viability units engrafted.Poor CD34+ viability correlated with lower CFUs (p=0.02).
Scaradavou, BBMT 2010
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BAD UNIT GOOD
GOOD UNIT
90% viable
50%viable
Unit Quality: Schema of CD34+s of 2 CB Units
Units similar infused viable CD34+ doses-but very different.
In part, double unit CBT effective as increases chance of transplanting at least one good quality unit.
Total CD34+ Cells in 2 Units
Unit #1 Unit #2
Scaradavou, BBMT 2010
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Implications• Unit quality varies from unit to unit, & bank to bank. Not all banks are the same.
• Factors that dictate unit quality need to be determined eg collection standards, processing methodology, red cell content, cryo volume, age.
• Methods to test unit quality prior to thaw should be priority eg testing the segment.
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Do the principles of single unit CBTalso apply to double unit CBT?
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Sustained Neutrophil Engraftment After Myeloablative DCBT by CD34+ Cell Dose of Engrafting Unit (n = 61)
>2.0 (n=10): 100%
@ 16.5 days
1.0-2.0 (n=13): 100%@ 20 days
<1.0 (n=38): 89%
@ 27.5 days
P < 0.001
High rate sustained engraftment directly dependent on infused CD34+ of winner; if low can be very slow.
Avery, Blood 2011
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Sust
aine
d N
eutr
ophi
l Eng
raft
men
t
Avery, Blood 2011
Total Graft Cell Dose & DCB Engraftment (n = 61)
Time Post Transplant (Days)
0.0
0.2
0.4
0.6
0.8
1.0
p = 0.10
0.0
0.2
0.4
0.6
0.8
1.0
p = 0.001p = 0.020.0
0.2
0.4
0.6
0.8
1.0
0.0
0.2
0.4
0.6
0.8
1.0
p = 0.00070 10 20 30 40 50 0 10 20 30 40 50
0 10 20 30 40 50 0 10 20 30 40 50
>4.3 x107/kg:100%
<4.3 x107/kg:87%
>1.8 x105/kg:97%
<1.8 x105/kg:90%
>6.2 x104/kg:97% <6.2 x104/kg:
90%
>7.8 x106/kg:97%
<7.8 x106/kg:90%
TNC CD34+
CFU CD3+
Total TNC & CD3+ dose of graft also have an effect.
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Months Post-Transplant
C.I.
Gra
de II
I-IV
aG
VH
D
0 1 2 3 4 5 6
20
40
60
80
100
0
2-7/10 HLA Match
8-9/10 HLA Match
Grade III-IV aGVHD by Engrafting Unit-Recipient 10 Allele HLA-Match (n = 115)
Recipient-Unit Match HR P2-7/10 (n = 88) Reference8-9/10 (n = 27) 0.37 0.105
P = 0.07 on multivariate: HLA-match likely critically important
Ponce, D., ASBMT 2012
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Evaluate search for units 4-6/6 & > 2.0 x 107/kg.
Review info & bank for each unit.Obtain missing info, CT units of interest.
Prepare CB Search Summary Report.
Rank units by A,-B antigen, -DRB1 allele match*Hi to low TNC within each match grade (correct for RBC).
6/6 units:Choose largest.
5/6 units: Choose largest.
4/6 units: Choose largest.
Make final selection of unit(s) (1a & 1b if double).
1st 2nd 3rd
Plan shipment(s)
Review CTs, update Search Summary
Prepare domestic back-up unit(s).
* Ignore unit-unit match in double unit CBT
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Require att. segment for identity testing & complete IDMs. Select on bank, dose, match, other (RBC content).
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What about higher resolution match?
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Kurtzberg, J. et al,Blood 2008
COBLT Single CBT: OS in Pediatric Malignancies
A, B, DRB1allele match:< 5/6 allele matchassociated with higher severe aGVHD.Trend towardimproved OSwith better match.
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Eapen, M. et al, Lancet, 2011
Effect of C: A,B,C Antigen, DRB1 Allele N = 803, median 10 yrs (<1 – 62), leukemia/ MDS
• Inferior neut engraftment with hi degree MM (< 5/8).• Worse GVHD if < 5/8 including HLA-A MM.• Relapse lower if any MM vs match (but no advantage to multiple mismatches.• TRM significantly worse if < 6/8 (trend for 7/8).• 3 year TRM: 8/8 9%; 7/8 (non-C) 19%; 7/8 (C) 26%; 6/8 (C + other) 31%.• Significance lost in overall mortality except for 6/8 (C + other). Contributed to by rel. high TNC of group?
C is important-but how to trade off against cell dose?What is new lower limit of acceptable match?
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New…… & Easy to Implement
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CI of Neutrophil Engraftment
Stevens C E et al. Blood 2011
Incorporating Vector of HLA-Match: 1202 Single Unit CBT, NYBC
Significant advantage to both 0 & GVHD vector only mismatches
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Stevens C E et al. Blood 2011;118:3969
CI of 3 Year TRM
HLA-Match Vector: 1202 Single Unit CBT
In heme maligs: GVH only mismatch equal to 0 mismatch.
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New……… But More Difficult to Implement
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NIMA-Match: 1121 Single Unit CBT, NYBC
van Rood J et al. PNAS 2009
3 Year TRM in Patients > 10 Years Old
If 1 MM,advantage ifthis is a NIMAmatch (predom. due tobetter neutrophilengraftment).
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0 HLA Mismatch (n=45) Shared IPA (n=751)
No Shared IPA (n=49)
C
.I. o
f Rel
a pse
0.2
0.4
0.8
1.0
0.6
0.0
Cox Regression: Multivariate
1-3 HLA MM, No Shared IPA Reference1-3 HLA MM, Shared IPA 0.4 <0.001 0 HLA MM 0.3 0.012
0 1 2 3 Years Post-Transplant
Relapse by Shared IPA: 845 Singles (AML/ALL)
Patient shares IPA = reduced relapse. ??Indirect evidence that maternal T-cells mediate GVL?
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• CB banks should report maternal HLA type.
• Should:o Select for NIMA match – expands no. of “well
matched” units. o Avoid “No Shared IPA” grafts in leukemics.
Implications for Unit Selection
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1) TNC/ HLA-match: Above 2.0 x 107/kg prioritize match Within match grade choose largest. Consider vector & C.
2) Also consider bank of origin (speed, reliability, quality).3) For malignancy use 2: Increase chance of transplanting at
least one unit of good quality PLUS unit vs unit effects may augment engraftment & reduce relapse.
4) For doubles same rules apply to selecting units 1 & 2. Ignore unit-unit HLA-match.
5) Consider hi res match if possible-esp in children.6) Unresolved issues: selecting based on CD34+ dose, red cell
content, testing of segment, high res match vs dose, incorporation of NIMA & IPA.
MSKCC Strategy for Unit Selection
Barker, Blood 2011 -How I Treat