In-vitro T-cell Depletion is Not Necessary for Haplo-identical Transplantation
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1 In-vitro T-cell Depletion is Not Necessary for Haplo-identical Transplantation Xiao-Jun Huang M.D. Peking University Institute of Hematology (PUIH), Peking University People s Hospital, Beijing Key Laboratory of HSCT, Beijing, P.R.China
2 Professor. Xiaojun HUANG Professor. Xiaojun HUANG Peking University Institute of Hematology, Peking University People s Hospital & Beijing Key Laboratory of HSCT, Beijing, P.R.China In-vitro T-cell Depletion is Not Necessaryfor Haplo-identical Transplantation Disclosure of Interest: Nothing to Disclose
3 Outline 1 The Feasibility of T-cell Replete (TCR) Haplo-HSCT 2 Comparsion of TCR with of In- vitro T-cell Depletion (TCD) Haplo-HSCT 3 Summary
4 We can overcome HLA barrier by manipulating T cell function but not T-cell depletion None- T cell depletion in vitro T cell depletion
5 Immune-regulatory Effects after G-CSF Administration to Healthy Donors 1.1 Beijing Protocol Huang XJ, et al. Biol Blood Marrow Transplant.2011;17(2):
6 Beijing Protocol for Haplo-HSCT 1.1 Beijing Protocol G: donor treatment with rhg-csf I: intensified immunological suppression A: anti-human thymocyte immunoglobulin (ATG) for the prevention of GVHD C: combination of G-PB and G-BM Huang XJ, et al. Bone Marrow Transplant, 2006, 38:291 Lu DP, et al. Blood, 2006, 107(8): Huang XJ, et al. Clin Cancer Res. 2009;15: Huang XJ, et al. Blood. 2012;119(23): Huang XJ, et al. Cancer Mar 1;119(5):
7 1.1 Beijing Protocol Haplo-HSCT cases accumulated in PUIH, Beijing Peking University Institute of Hematology(PUIH)Data
8 patients with leukemia 1.1 Beijing Protocol 756 patients, with a median age of 25, were enrolled. Conditioning : moidifed Bu/Cy Graft: unmanipulated G-BM+G+PB GVHD prophylaxis: CSA + low dose MTX+MMF Huang XJ, et al. Cancer Mar 1;119(5):
9 1.1 Beijing Protocol Engraftment (Disease Status) ANC Platelet p=0.068 p=0.113 Huang XJ, et al. Cancer Mar 1;119(5):
10 agvhd 2-4 (HLA Disparity) 1.1 Beijing Protocol p=0.39 p=0.08 Huang XJ, et al. Cancer Mar 1;119(5):
11 1.1 Beijing Protocol agvhd 3-4 (HLA Disparity) p=0.75 Huang XJ, et al. Cancer Mar 1;119(5):
12 1.1 Beijing Protocol Disease Type Disease Status p=0.527 p=0.001 cgvhd Extensive Huang XJ, et al. Cancer Mar 1;119(5):
13 1.1 Beijing Protocol LFS (HLA disparity) p=0.243 Huang XJ, et al. Cancer Mar 1;119(5):
14 1.1 Beijing Protocol Haplo-HSCT has similar therapeutic effect compared with HLA matched sibling donor or matched unrelated donor HSCT
15 Haplo-HSCT patients can achieve desirable healthrelated quality of life comparable to MSD-HSCT patients Physical HRQoL measure ISD(n=173) mean±s,d. PMRD (n=177) mean±s,d. P value Physical component (PCS) 46.9± ± Physical functioning 82.7± ± Role functioning-physical 57.4± ± Bodily pain 75.5± ±18.7 < General health 60.6± ± Psychological 2. Health status in survivors Mental component (MCS) 52.2± ± Vitality 66.6± ±15.6 < Social functioning 72.8± ± Role functioning-emotional 65.9± ± Mental health 76.1± ± Higher score indicated better functioning with a population mean of 50 and an s.d.of 10. HuangXJ, Bone Marrow Transplant 2012; 47:
16 Biol Blood Marrow Transplant Feb 5. doi:pii: S (13) /j.bbmt Multiple late effects ( 2) The time interval between the first and the second late effect: ISD: 51 days versus PMRD: 262 days (P=0.076). P= % ± 0.1% 17.9% ± 0.1%
17 1.1 Beijing Protocol Prospective, Multicenter Study for Chemotherapy and Haplo-HSCT in CR1 for AML patients MSD Matched Sibling MUD Matched Unrelated HRD Haplo Related
18 1.1 Beijing Protocol Haplo-HSCT is Superior to Chemotherapy as Post-Remission Treatment for Intermediate or High risk AML in CR1 Relapse DFS Huang XJ, et al. Blood. 2012;119:
19 1.1 Beijing Protocol Unmanipulated Haploidentical blood and marrow transplantation for patients with SSA 19 patients, with a median age of 19, were enrolled. Male/Female: 7/11 Conditioning : Bu+Cy+ATG (n=19) Graft: unmanipulated G-BM+G+PB GVHD prophylaxis: CSA + low dose MTX+MMF Huang XJ, et al.bone Marrow Transplant. 2012;47:
20 1.1 Beijing Protocol Acute GVHD Chronic GVHD Huang XJ, et al.bone Marrow Transplant. 2012;47:
21 1.1 Beijing Protocol Overall survival for SAA with Haplo-HSCT Huang XJ, et al.bone Marrow Transplant. 2012;47:
22 1.1 Myeloablative TCR Haplo-HSCT Summary of Haplo-HSCT in China Related Match Related Haplo Unrelated Cord Haplo% 31.7% 30.5% 28.3% 30.7% Chinese HSCT Register Group Data from 40 units
23 Non-Myeloablative Haplo-HSCT with Unmanipulated S-BM Reduced-Intensity Conditioning : Fludarabine+ CTX+TBI Johns Hopkins University U.S.A Graft: PBMC without Manipulation of T cells GVHD prophylaxis:hi-ctx+mmf+fk506 Patients (n) Disease AL/NHL /CML/ MDS AML/AL L/MDS Engraft ment 2-4 aghvd cgvh D 1.2 Non- Myeloablative TCR Haplo-HSCT TRM Relapse LFS Reference 87% 27% 13% 18% 55% 3y:32% 96% 32% 13% 31% 45% 1y:46% Fuchs EJ. et al. (2008) Fuchs EJ. et al. (2011) Fuchs EJ, et al. BBMT Jun;14(6):641-50; Blood.2011 Jul 14;118(2):282-8
24 Summary of TCR Haplo-HSCT Patien ts Diseas Conditionin e g AL/M DS AL/M DS AL/M DS AL/C ML AML/ ALL/C ML/O thers AL/C ML/N HL/AA Graft GVHD Prophylaxis GR agvhd cgvhd TRM LFS Nation Referenc e RIC:TBI/flu/ Bu/ATG/me PB or BM FK % (II-IV)38% 57.5% 28.8@4yea rs lphalan RIC:Bu/Flu/ ATG RIC:Cy/Flu/ TBI ST:Bu/Cy/ MeCCNU/A TG ST:Thiotepa +Bu+Flu or others ST:Bu/Cy/A ra- C/MeCCNU +ATG PB/No CsA+MTX 0 24% 28% BM/No Cy(HD)+FK50 6+MMF PB/No BM/No BM+PB/ No CsA+MTX+M MF ATG+CSA+M TX+MMF+CD 25 CsA+MTX+M MF 4% (II-IV)32% 13% 0 (II- IV)33.8% 17%@1 year 7%@1y ear 9% (II-IV)24% 17% 34% <1% (II-IV) 42.9% ( III-IV) 14.0% AML/MDS CR53%- 60%;AML RE9% 46%@1yea r 55.6%@2ye 39.5% 20%@2 ars years Total 53.7% Extensive years yrs Italy SR68.1% HR47.1% Japan Kurokaw a(2010) Korea Lee(2011 ) U.S.A Fuchs(20 11) China Yu(2012) China Bartolom eod (2013) Huang(2 013)
25 3.3 TCD Vs. TCR-M.D Anderson M.D Anderson TCD Vs. TCR Design Conditioning Graft TCD ST:Melphalan+ Thiotepa+Flu +ATG CD34+Selection G-PB TCR ST:Melphalan+ Thiotepa+Flu (part RIC) Unmanipulated BM GVHD Prophylaxis No Cy+FK506+MMF Champlin RE, et al. Biol Blood Marrow Transplant Dec;18(12):
26 3.3 TCD Vs. TCR-M.D Anderson agvhd & cgvhd Champlin RE, et al. Biol Blood Marrow Transplant Dec;18(12):
27 3.3 TCD Vs. TCR-M.D Anderson Non Relapse Mortality Champlin RE, et al. Biol Blood Marrow Transplant Dec;18(12):
28 3.3 TCD Vs. TCR-M.D Anderson 2-year OS and DFS Champlin RE, et al. Biol Blood Marrow Transplant Dec;18(12):
29 3.1 TCD Vs. TCR--General Comparison Comparison of IR between TCR and TCD haploidentical protocol Beijing China Perugia Italy Protocol TCR CD34+ TCD Tuebingen Germany CD3-CD19- TCD Johns Hopkins U.S.A RIC-TCR CD3 (/ul) 883 at day at day at day 100 Not avalaible CD4 (/ul) 277 at day 360 Not avalaible 181 at day at day 180 CD8 (/ul) 672 at day at day at day 100 Not avalaible 918 at day at day at day 400 Not avalaible CD19 (/ul) 125 at day 360 Not avalaible Not avalaible Not avalaible CD56 (/ul) 250 at day at day at day 20 Not avalaible Huang XJ, et al. Semin Oncol Dec;39(6):653-63
30 3.1 TCD Vs. TCR--General Comparison Overview of outcomes between TCR and TCD Haplo-HSCT agvhd 2-4 cgvhd Graft Failure NRM Based on the listed data
31 Summary of T-Cell Repleted HSCT Advantages Absence of technical expertise and cost of TCD High T-cell content of allografts potentially enhances the GVL effect Accelerated immune reconstitution Disadvantages Potentially severe GVHD induced by T cells
32 Conclusion: In-vitro T-cell Depletion is Not Necessary for Haplo-identical Transplantation TCR Haplo-HSCT protocols based on in-vivo modulation of T cell functions by G-CSF combined with ATG, CsA etal are simple and practicable. TCR Haplo-HSCT may have advantages: Engraftment, Lower NRM, rapid immune reconstitution, GVL effect and LFS/OS. cgvhd remains to be improved
33 Acknowledgements Department of Bone Marrow Transplant Dai-Hong Liu Feng-Rong Wang Huan Chen Jing-Zhi Wang Kai-Yan Liu Lan-Ping Xu Wei Han Xiao-Hui Zhang Yu-Hong Chen Yu Wang Stem cell collection center Hai-Yin Zheng Hong Xu Qing Zhao Su Wang Laboratory of PUIH Dan Li Ya-Zhen Qin Yan-Rong Liu Yue-Yun Lai
34 35 th World Congress of the International Society of Hematology, 2014 Organized by: International Society of Hematology Chinese Society of Hematology President: Prof. Xiaojun Huang Co-chairs: Prof. Changgeng Ruan Prof. Saijuan Chen General Secretary: Prof. Kaiyan Liu Venue: China National Convention Center, Beijing, China Date: Sept. 4-7, 2014 Congress Website:
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