Abstract
Autologous (auto-) and allogeneic (allo-) hematopoietic cell transplantation (HCT) are accepted treatment modalities in contemporary treatment algorithms for mantle cell lymphoma (MCL). Chimeric antigen receptor (CAR) T cell therapy recently received approval for MCL; however, its exact place and sequence in relation to HCT remain unclear. The American Society of Transplantation and Cellular Therapy, Center of International Blood and Marrow Transplant Research, and the European Society for Blood and Marrow Transplantation jointly convened an expert panel to formulate consensus recommendations for role, timing, and sequencing of auto-HCT, allo-HCT, and CAR T cell therapy for patients with newly diagnosed and relapsed/refractory (R/R) MCL. The RAND-modified Delphi method was used to generate consensus statements. Seventeen consensus statements were generated, with a few key statements as follows: in the first line setting, auto-HCT consolidation represents standard of care in eligible patients, whereas there is no clear role of allo-HCT or CAR T cell therapy outside of clinical trials. In the R/R setting, the preferential option is CAR T cell therapy, especially in patients with MCL failing or intolerant to at least one Bruton's tyrosine kinase inhibitor, while allo-HCT is recommended if CAR T cell therapy fails or is infeasible. Several recommendations were based on expert opinion, where the panel developed consensus statements for important real-world clinical scenarios to guide clinical practice. In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MCL.
Original language | English |
---|---|
Pages (from-to) | 720-728 |
Number of pages | 9 |
Journal | Transplantation and Cellular Therapy |
Volume | 27 |
Issue number | 9 |
DOIs | |
State | Published - Sep 2021 |
Keywords
- Allogeneic transplantation
- Autologous transplantation
- CAR T cell
- Cellular therapy
- Consensus
- Mantle cell lymphoma
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In: Transplantation and Cellular Therapy, Vol. 27, No. 9, 09.2021, p. 720-728.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - American Society of Transplantation and Cellular Therapy, Center of International Blood and Marrow Transplant Research, and European Society for Blood and Marrow Transplantation Clinical Practice Recommendations for Transplantation and Cellular Therapies in Mantle Cell Lymphoma
AU - Munshi, Pashna N.
AU - Hamadani, Mehdi
AU - Kumar, Ambuj
AU - Dreger, Peter
AU - Friedberg, Jonathan W.
AU - Dreyling, Martin
AU - Kahl, Brad
AU - Jerkeman, Mats
AU - Kharfan-Dabaja, Mohamed A.
AU - Locke, Frederick L.
AU - Shadman, Mazyar
AU - Hill, Brian T.
AU - Ahmed, Sairah
AU - Herrera, Alex F.
AU - Sauter, Craig S.
AU - Bachanova, Veronika
AU - Ghosh, Nilanjan
AU - Lunning, Matthew
AU - Kenkre, Vaishalee P.
AU - Aljurf, Mahmoud
AU - Wang, Michael
AU - Maddocks, Kami J.
AU - Leonard, John P.
AU - Kamdar, Manali
AU - Phillips, Tycel
AU - Cashen, Amanda F.
AU - Inwards, David J.
AU - Sureda, Anna
AU - Cohen, Jonathon B.
AU - Smith, Sonali M.
AU - Carlo-Stella, Carmello
AU - Savani, Bipin
AU - Robinson, Stephen P.
AU - Fenske, Timothy S.
N1 - Funding Information: Financial disclosure: The CIBMTR is supported primarily by Public Health Service Grant U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI), and the National Institute of Allergy and Infectious Diseases (NIAID); Grant U24HL138660 from the NHLBI and NCI; Grants OT3HL147741 and U01HL128568 from the NHLBI; Grants HHSH250201700006C and HHSH250201700007C from the Health Resources and Services Administration (HRSA); and Awards N00014-20-1-2705 and N00014-20-1-2832 from the Office of Naval Research. Additional federal support is provided by National Institutes of Health (NIH) Grants P01CA111412, R01CA152108, R01CA215134, R01CA218285, R01CA231141, R01AI128775, R01HL126589, R01HL129472, R01HL130388, R01HL131731, U01AI069197, U01AI126612, and UG1HL06924, and the Biomedical Advanced Research and Development Authority. Support is also provided by the Be the Match Foundation, Boston Children's Hospital, Dana-Farber Cancer Institute, St Baldrick's Foundation, Stanford University, Medical College of Wisconsin, National Marrow Donor Program, and the following commercial entities: Actinium Pharmaceuticals, Adienne, AlloVir, Amgen, Angiocrine Bioscience, Astellas Pharma US, bluebird bio, Bristol Myers Squibb, Celgene, CSL Behring, CytoSen Therapeutics, Daiichi Sankyo, ExcellThera, Fate Therapeutics, Gamida Cell, Genentech, Incyte; Janssen/Johnson & Johnson, Jazz Pharmaceuticals, Kiadis Pharma, Kite Pharma, Kyowa Kirin, Legend Biotech, Magenta Therapeutics, Merck Sharp & Dohme, Millennium, Miltenyi Biotec, Novartis Pharmaceuticals, Omeros, OncoImmune, Orca Biosystems, Pfizer, Pharmacyclics, Sanofi Genzyme, StemCyte, Takeda Pharma, Vor Biopharma, and Xenikos. The views expressed in this article do not reflect the official policy or position of the NIH, Department of the Navy, Department of Defense, HRSA, or any other agency of the US Government. Funding Information: Conflict of interest statement: M.H. reports receiving research support/funding from Takeda Pharmaceutical, Spectrum Pharmaceuticals, and Astellas Pharma; serving as a consultant for Janssen, Incyte, ADC Therapeutics, Celgene, Omeros, Verastem, and MorphoSys; and serving on speakers bureaus for Sanofi Genzyme, AstraZeneca, and BeiGene. T.S.F. reports receiving research support/funding from Novartis, Portola, Curis; serving as a consultant to Adaptive Biotechnologies, AbbVie, KaryoPharm, Kite Pharma, MorphoSys, Pharmacyclics, and Sanofi; and serving on speakers bureaus for Sanofi, Seattle Genetics, AstraZeneca, Celgene/Bristol-Myers Squibb, and Adaptive Biotechnologies. P.N.M. reports serving on speakers bureaus for Kite Pharma and Incyte. J.V.C. reports serving on consulting/advisory boards for Janssen, Adicet, BeiGene, Cellectar, Kite Pharma/Gilead, Adaptive, Aptitude Health, AstraZeneca, and Loxo and receiving research support/funding from Novartis, BMS/Celgene, Takeda, Genentech, AstraZeneca, Loxo, LAM, Atara, and BeiGene. N.G. reports serving on speakers bureau for Kite Pharma, AstraZeneca, AbbVie, Janssen, BMS, and Epizyme; serving on consulting/advisory boards for Kite Pharma, AstraZeneca, AbbVie, Janssen, BMS, Incyte, Epizyme, Karyopharma, Genmab, Adaptive Biotech, TG Therapeutics, ADC Therapeutics, and BeiGene; and receiving research funding from Genentech/Roche, BMS, TG Therapeutics, Pharmacyclics, and Kite Pharma. M.K. reports receiving research support/funding from TG Therapeutics and Genentech; serving as a consultant for AbbVie, KaryoPharm, Kite Pharma, AstraZeneca, Celgene/Bristol-Myers Squibb, Adaptive Biotechnologies, and Curio Science; and serving on the speakers bureau for SeaGen. M.J. reports receiving research support/funding from Janssen, Celgene, Abbvie, Gilead, and Roche, and serving as a consultant for Janssen, Incyte, Gilead, Roche, Bristol-Myers Squibb, Acerta, and BioInvent. J.W.F. served on data safety and monitoring boards for Bayer, Ascerta, and Novartis. C.C.-S. reports receiving research support/funding from ADC Therapeutics, Sanofi, and Roche; serving on consultant/advisory boards for Sanofi, ADC Therapeutics, Roche, Karyopharm Therapeutics, Celgene/Bristol-Myers Squibb, and Incyte; receiving honoraria from Bristol-Myers Squibb, Janssen Oncology, and AstraZeneca; and receiving travel grants from Roche, Janssen, Takeda, and ADC Therapeutics. V.B. reports serving on advisory boards for Kite Pharma and Gamida Cell and receiving research support/funding from Incyte, Gamida Cell, and GT Biopharma. T.P. reports receiving research support/funding from Incyte, BMS/Celgene, Bayer, Abbvie, and Genentech; serving as a consultant for BMS, Bayer, AbbVie, Genentech, Gilead, Gilead/Kite TG Therapeutics, ADC Therapeutics, Incyte, MorphoSys, BeiGene, AstraZenca, and Epizyme. F.L.L. reports receiving research support/funding from Kite Pharma; serving as a scientific advisor for Allogene, Amgen, bluebird bio, BMS/Celgene, Calibr, Celgene, GammaDelta Therapeutics, Iovance, Kite Pharma/Gilead, Legend Biotech, Novartis, and Wugen; and serving as a consultant for Cellular Biomedicine Group, Cowen Consulting, Gerson Lehrman Group, EcoR1, and Emerging Therapies. B.K. reports receiving research support/funding from AbbVie, Acerta, AstraZeneca, Beigene, Celgene, and Genentech and serving as a consultant for AbbVie, Acerta, AstraZeneca, Beigene, Celgene, Kite Pharma, Genentech, Pharmacyclics, and Janssen. M.A.K-D. reports serving as a consultant for Pharmacyclics and Daiichi Sankyo. A.F.H. reports serving as a consulting/advisor for Bristol-Myers Squibb, Merck, Seattle Genetics, Karyopharm, Genentech/Roche; receiving institutional research funding from Bristol-Myers Squibb, Genentech/Roche, Merck, Seattle Genetics, ADC Therapeutics, and Gilead/Kite Pharma; and receiving travel, accommodations, and expenses from Bristol-Myers Squibb. K.J.M. reports receiving research funding from Pharmacyclics, BMS, Merck, and Novartis and serving as a consultant for Pharmacyclics, Janssen, Morphosys, Celgene, Beigene, Kite Pharma, Karyopharm, ADC Therapeutics, and Seattle Genetics. V.P.K. reports research funding from Novartis. D.I. reports research funding from Acerta Pharma. C.S.S. reports serving on consultancy/advisory boards for Juno Therapeutics, Sanofi-Genzyme, Spectrum Pharmaceuticals, Novartis, Genmab, Precision Biosciences, Kite Pharma, Celgene/BMS, Gaqmida Cell, Karyopharm Therapeutics, and GSK and receiving research funding from Juno Therapeutics, Celgene/BMS, Bristol-Myers Squibb, Precision Biosciences, and Sanofi-Genzyme. P.D. reports serving as a consultant for AbbVie, AstraZeneca, bluebird bio, Gilead, Janssen, Novartis, Riemser, and Roche; serving on speakers bureaus for AbbVie, AstraZeneca, Gilead, Novartis, Riemser, and Roche; and receiving research support from Riemser. J.P.L. reports receiving research support from the Leukemia & Lymphoma Society and the Genentech Foundation and serving as a consultant for Sutro, Miltenyi Biotech, AstraZeneca, Epizyme, BMS/Celgene, Regeneron, Bayer, Gilead/Kite Pharma, Karyopharm, Genmab, Genentech/Roche, AbbVie, and Incyte. M.D. reports receiving institutional research funding from AbbVie, Bayer, Celgene, Janssen, and Roche; serving on advisory boards for AstraZeneca, Bayer, BeiGene, Celgene, Genmab, Gilead, Incyte, Janssen, Novartis, and Roche; and receiving speaker's honoraria from Amgen, AstraZeneca, Bayer, Celgene, Gilead, Janssen, and Roche. B.T.H. reports receiving research funding from Kite Pharma/Gilead, Celgene/BMS, Genentech, Pharmacyclics, and AbbVie and serving as a consultant for Kite Pharma/Gilead, Celgene/BMS, Novartis, Beigene, AstraZeneca, Genentech, and AbbVie. The other authors have no conflicts of interest to report. Funding Information: Financial disclosure: The CIBMTR is supported primarily by Public Health Service Grant U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI), and the National Institute of Allergy and Infectious Diseases (NIAID); Grant U24HL138660 from the NHLBI and NCI; Grants OT3HL147741 and U01HL128568 from the NHLBI; Grants HHSH250201700006C and HHSH250201700007C from the Health Resources and Services Administration (HRSA); and Awards N00014-20-1-2705 and N00014-20-1-2832 from the Office of Naval Research. Additional federal support is provided by National Institutes of Health (NIH) Grants P01CA111412, R01CA152108, R01CA215134, R01CA218285, R01CA231141, R01AI128775, R01HL126589, R01HL129472, R01HL130388, R01HL131731, U01AI069197, U01AI126612, and UG1HL06924, and the Biomedical Advanced Research and Development Authority. Support is also provided by the Be the Match Foundation, Boston Children's Hospital, Dana-Farber Cancer Institute, St Baldrick's Foundation, Stanford University, Medical College of Wisconsin, National Marrow Donor Program, and the following commercial entities: Actinium Pharmaceuticals, Adienne, AlloVir, Amgen, Angiocrine Bioscience, Astellas Pharma US, bluebird bio, Bristol Myers Squibb, Celgene, CSL Behring, CytoSen Therapeutics, Daiichi Sankyo, ExcellThera, Fate Therapeutics, Gamida Cell, Genentech, Incyte; Janssen/Johnson & Johnson, Jazz Pharmaceuticals, Kiadis Pharma, Kite Pharma, Kyowa Kirin, Legend Biotech, Magenta Therapeutics, Merck Sharp & Dohme, Millennium, Miltenyi Biotec, Novartis Pharmaceuticals, Omeros, OncoImmune, Orca Biosystems, Pfizer, Pharmacyclics, Sanofi Genzyme, StemCyte, Takeda Pharma, Vor Biopharma, and Xenikos. The views expressed in this article do not reflect the official policy or position of the NIH, Department of the Navy, Department of Defense, HRSA, or any other agency of the US Government. Conflict of interest statement: M.H. reports receiving research support/funding from Takeda Pharmaceutical, Spectrum Pharmaceuticals, and Astellas Pharma; serving as a consultant for Janssen, Incyte, ADC Therapeutics, Celgene, Omeros, Verastem, and MorphoSys; and serving on speakers bureaus for Sanofi Genzyme, AstraZeneca, and BeiGene. T.S.F. reports receiving research support/funding from Novartis, Portola, Curis; serving as a consultant to Adaptive Biotechnologies, AbbVie, KaryoPharm, Kite Pharma, MorphoSys, Pharmacyclics, and Sanofi; and serving on speakers bureaus for Sanofi, Seattle Genetics, AstraZeneca, Celgene/Bristol-Myers Squibb, and Adaptive Biotechnologies. P.N.M. reports serving on speakers bureaus for Kite Pharma and Incyte. J.V.C. reports serving on consulting/advisory boards for Janssen, Adicet, BeiGene, Cellectar, Kite Pharma/Gilead, Adaptive, Aptitude Health, AstraZeneca, and Loxo and receiving research support/funding from Novartis, BMS/Celgene, Takeda, Genentech, AstraZeneca, Loxo, LAM, Atara, and BeiGene. N.G. reports serving on speakers bureau for Kite Pharma, AstraZeneca, AbbVie, Janssen, BMS, and Epizyme; serving on consulting/advisory boards for Kite Pharma, AstraZeneca, AbbVie, Janssen, BMS, Incyte, Epizyme, Karyopharma, Genmab, Adaptive Biotech, TG Therapeutics, ADC Therapeutics, and BeiGene; and receiving research funding from Genentech/Roche, BMS, TG Therapeutics, Pharmacyclics, and Kite Pharma. M.K. reports receiving research support/funding from TG Therapeutics and Genentech; serving as a consultant for AbbVie, KaryoPharm, Kite Pharma, AstraZeneca, Celgene/Bristol-Myers Squibb, Adaptive Biotechnologies, and Curio Science; and serving on the speakers bureau for SeaGen. M.J. reports receiving research support/funding from Janssen, Celgene, Abbvie, Gilead, and Roche, and serving as a consultant for Janssen, Incyte, Gilead, Roche, Bristol-Myers Squibb, Acerta, and BioInvent. J.W.F. served on data safety and monitoring boards for Bayer, Ascerta, and Novartis. C.C.-S. reports receiving research support/funding from ADC Therapeutics, Sanofi, and Roche; serving on consultant/advisory boards for Sanofi, ADC Therapeutics, Roche, Karyopharm Therapeutics, Celgene/Bristol-Myers Squibb, and Incyte; receiving honoraria from Bristol-Myers Squibb, Janssen Oncology, and AstraZeneca; and receiving travel grants from Roche, Janssen, Takeda, and ADC Therapeutics. V.B. reports serving on advisory boards for Kite Pharma and Gamida Cell and receiving research support/funding from Incyte, Gamida Cell, and GT Biopharma. T.P. reports receiving research support/funding from Incyte, BMS/Celgene, Bayer, Abbvie, and Genentech; serving as a consultant for BMS, Bayer, AbbVie, Genentech, Gilead, Gilead/Kite TG Therapeutics, ADC Therapeutics, Incyte, MorphoSys, BeiGene, AstraZenca, and Epizyme. F.L.L. reports receiving research support/funding from Kite Pharma; serving as a scientific advisor for Allogene, Amgen, bluebird bio, BMS/Celgene, Calibr, Celgene, GammaDelta Therapeutics, Iovance, Kite Pharma/Gilead, Legend Biotech, Novartis, and Wugen; and serving as a consultant for Cellular Biomedicine Group, Cowen Consulting, Gerson Lehrman Group, EcoR1, and Emerging Therapies. B.K. reports receiving research support/funding from AbbVie, Acerta, AstraZeneca, Beigene, Celgene, and Genentech and serving as a consultant for AbbVie, Acerta, AstraZeneca, Beigene, Celgene, Kite Pharma, Genentech, Pharmacyclics, and Janssen. M.A.K-D. reports serving as a consultant for Pharmacyclics and Daiichi Sankyo. A.F.H. reports serving as a consulting/advisor for Bristol-Myers Squibb, Merck, Seattle Genetics, Karyopharm, Genentech/Roche; receiving institutional research funding from Bristol-Myers Squibb, Genentech/Roche, Merck, Seattle Genetics, ADC Therapeutics, and Gilead/Kite Pharma; and receiving travel, accommodations, and expenses from Bristol-Myers Squibb. K.J.M. reports receiving research funding from Pharmacyclics, BMS, Merck, and Novartis and serving as a consultant for Pharmacyclics, Janssen, Morphosys, Celgene, Beigene, Kite Pharma, Karyopharm, ADC Therapeutics, and Seattle Genetics. V.P.K. reports research funding from Novartis. D.I. reports research funding from Acerta Pharma. C.S.S. reports serving on consultancy/advisory boards for Juno Therapeutics, Sanofi-Genzyme, Spectrum Pharmaceuticals, Novartis, Genmab, Precision Biosciences, Kite Pharma, Celgene/BMS, Gaqmida Cell, Karyopharm Therapeutics, and GSK and receiving research funding from Juno Therapeutics, Celgene/BMS, Bristol-Myers Squibb, Precision Biosciences, and Sanofi-Genzyme. P.D. reports serving as a consultant for AbbVie, AstraZeneca, bluebird bio, Gilead, Janssen, Novartis, Riemser, and Roche; serving on speakers bureaus for AbbVie, AstraZeneca, Gilead, Novartis, Riemser, and Roche; and receiving research support from Riemser. J.P.L. reports receiving research support from the Leukemia & Lymphoma Society and the Genentech Foundation and serving as a consultant for Sutro, Miltenyi Biotech, AstraZeneca, Epizyme, BMS/Celgene, Regeneron, Bayer, Gilead/Kite Pharma, Karyopharm, Genmab, Genentech/Roche, AbbVie, and Incyte. M.D. reports receiving institutional research funding from AbbVie, Bayer, Celgene, Janssen, and Roche; serving on advisory boards for AstraZeneca, Bayer, BeiGene, Celgene, Genmab, Gilead, Incyte, Janssen, Novartis, and Roche; and receiving speaker's honoraria from Amgen, AstraZeneca, Bayer, Celgene, Gilead, Janssen, and Roche. B.T.H. reports receiving research funding from Kite Pharma/Gilead, Celgene/BMS, Genentech, Pharmacyclics, and AbbVie and serving as a consultant for Kite Pharma/Gilead, Celgene/BMS, Novartis, Beigene, AstraZeneca, Genentech, and AbbVie. The other authors have no conflicts of interest to report. Authorship statement: Conception and design: P.N.M. T.S.F. B.N.S. S.R, and M.H. Collection and assembly of data: P.N.M. T.S.F. A.K. and M.H. Data analysis: A.K. Data interpretation: All authors. Manuscript writing: first draft prepared by P.N.M. T.S.F. and M.H.; revisions done by all authors. Final approval of manuscript: all authors. Publisher Copyright: © 2021
PY - 2021/9
Y1 - 2021/9
N2 - Autologous (auto-) and allogeneic (allo-) hematopoietic cell transplantation (HCT) are accepted treatment modalities in contemporary treatment algorithms for mantle cell lymphoma (MCL). Chimeric antigen receptor (CAR) T cell therapy recently received approval for MCL; however, its exact place and sequence in relation to HCT remain unclear. The American Society of Transplantation and Cellular Therapy, Center of International Blood and Marrow Transplant Research, and the European Society for Blood and Marrow Transplantation jointly convened an expert panel to formulate consensus recommendations for role, timing, and sequencing of auto-HCT, allo-HCT, and CAR T cell therapy for patients with newly diagnosed and relapsed/refractory (R/R) MCL. The RAND-modified Delphi method was used to generate consensus statements. Seventeen consensus statements were generated, with a few key statements as follows: in the first line setting, auto-HCT consolidation represents standard of care in eligible patients, whereas there is no clear role of allo-HCT or CAR T cell therapy outside of clinical trials. In the R/R setting, the preferential option is CAR T cell therapy, especially in patients with MCL failing or intolerant to at least one Bruton's tyrosine kinase inhibitor, while allo-HCT is recommended if CAR T cell therapy fails or is infeasible. Several recommendations were based on expert opinion, where the panel developed consensus statements for important real-world clinical scenarios to guide clinical practice. In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MCL.
AB - Autologous (auto-) and allogeneic (allo-) hematopoietic cell transplantation (HCT) are accepted treatment modalities in contemporary treatment algorithms for mantle cell lymphoma (MCL). Chimeric antigen receptor (CAR) T cell therapy recently received approval for MCL; however, its exact place and sequence in relation to HCT remain unclear. The American Society of Transplantation and Cellular Therapy, Center of International Blood and Marrow Transplant Research, and the European Society for Blood and Marrow Transplantation jointly convened an expert panel to formulate consensus recommendations for role, timing, and sequencing of auto-HCT, allo-HCT, and CAR T cell therapy for patients with newly diagnosed and relapsed/refractory (R/R) MCL. The RAND-modified Delphi method was used to generate consensus statements. Seventeen consensus statements were generated, with a few key statements as follows: in the first line setting, auto-HCT consolidation represents standard of care in eligible patients, whereas there is no clear role of allo-HCT or CAR T cell therapy outside of clinical trials. In the R/R setting, the preferential option is CAR T cell therapy, especially in patients with MCL failing or intolerant to at least one Bruton's tyrosine kinase inhibitor, while allo-HCT is recommended if CAR T cell therapy fails or is infeasible. Several recommendations were based on expert opinion, where the panel developed consensus statements for important real-world clinical scenarios to guide clinical practice. In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MCL.
KW - Allogeneic transplantation
KW - Autologous transplantation
KW - CAR T cell
KW - Cellular therapy
KW - Consensus
KW - Mantle cell lymphoma
UR - http://www.scopus.com/inward/record.url?scp=85115347371&partnerID=8YFLogxK
U2 - 10.1016/j.jtct.2021.03.001
DO - 10.1016/j.jtct.2021.03.001
M3 - Article
C2 - 34452722
AN - SCOPUS:85115347371
SN - 2666-6367
VL - 27
SP - 720
EP - 728
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 9
ER -