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1. Haploidentical transplantation and posttransplant cyclophosphamide for treating aplastic anemia patients: a report from the EBMT Severe Aplastic Anemia Working Party

Author

Prata, P.H., Eikema, D.J., Afansyev, B., Bosman, P., Smiers, F., Diez-Martin, J.L., Arrais-Rodrigues, C., Koc, Y., Poir?, X., Sirvent, A., Kr?ger, N., Porta, F., Holter, W., Bloor, A., Jubert, C., Ganser, A., Tanase, A., M?nard, A.L., Pioltelli, P., P?rez-Sim?n, J.A., Ho, A., Aljurf, M., Russell, N., Labussiere-Wallet, H., Kerre, T., Rocha, V., Soci?, G., Risitano, A., Dufour, C., Latour, R.P. de, SAA WP EBMT, Prata, P. H., Eikema, D. -J., Afansyev, B., Bosman, P., Smiers, F., Diez-Martin, J. L., Arrais-Rodrigues, C., Koc, Y., Poire, X., Sirvent, A., Kroger, N., Porta, F., Holter, W., Bloor, A., Jubert, C., Ganser, A., Tanase, A., Menard, A. -L., Pioltelli, P., Perez-Simon, J. A., Ho, A., Aljurf, M., Russell, N., Labussiere-Wallet, H., Kerre, T., Rocha, V., Socie, G., Risitano, A., Dufour, C., and Peffault de Latour, R.

Subjects
medicine.medical_specialty, Transplantation Conditioning, Cyclophosphamide, medicine.medical_treatment, Eltrombopag, Graft vs Host Disease, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Medicine, Humans, Cumulative incidence, Prospective Studies, Aplastic anemia, Prospective cohort study, Transplantation, Univariate analysis, Neutrophil Engraftment, business.industry, Hematopoietic Stem Cell Transplantation, Anemia, Aplastic, Immunosuppression, Hematology, medicine.disease, Europe, chemistry, 030220 oncology & carcinogenesis, Transplantation, Haploidentical, business, 030215 immunology, medicine.drug
Abstract

In Press., In the absence of an HLA-matched donor, the best treatment for acquired aplastic anemia patients refractory to immunosuppression is unclear. We collected and analyzed data from all acquired aplastic anemia patients who underwent a haploidentical transplantation with posttransplant cyclophosphamide in Europe from 2011 to 2017 (n = 33). The cumulative incidence of neutrophil engraftment was 67% (CI95%: 51–83%) at D +28 and was unaffected by age group, stem cell source, ATG use, or Baltimore conditioning regimen. The cumulative incidence of grades II–III acute GvHD was 23% at D +100, and limited chronic GvHD was 10% (0–20) at 2 years, without cases of grade IV acute or extensive chronic GvHD. Two-year overall survival was 78% (64–93), and 2-year graft-versus-host disease-free survival was 63% (46–81). In univariate analysis, the 2-year OS was higher among patients who received the Baltimore conditioning regimen (93% (81–100) versus 64% (41–87), p = 0.03), whereas age group, stem cell source, and ATG use had no effect. Our results using unmanipulated haploidentical transplantation and posttransplant cyclophosphamide for treating refractory AA patients are encouraging, but warrant confirmation in a prospective study with a larger number of patients and longer follow-up.

Published
2019

2. Role of HLA-B exon 1 in graft-versus-host disease after unrelated haemopoietic cell transplantation: a retrospective cohort study

Author

Effie W Petersdorf, Mary Carrington, Colm O'hUigin, Mats Bengtsson, Dianne De Santis, Valerie Dubois, Ted Gooley, Mary Horowitz, Katharine Hsu, J Alejandro Madrigal, Martin J Maiers, Mari Malkki, Caroline McKallor, Yasuo Morishima, Machteld Oudshoorn, Stephen R Spellman, Jean Villard, Phil Stevenson, Martin Maiers, Stephen Spellman, Jane Apperley, Peter Bardy, Ghislaine Bernard, Yves Bertrand, Adrian Bloor, Chiara Bonini, Stephane Buhler, Laura Bungener, Helen Campbell, Kristina Carlson, Ben Carpenter, Anne Cesbron, Christian Chabannon, Yves Chalandon, Jeremy Chapman, Réda Chebel, Patrice Chevallier, Gerda Choi, Matt Collin, Jan J Cornelissen, Charles Crawley, Lloyd D'Orsogna, Jean-Hugues Dalle, Eric Deconinck, Muriel DeMatteis, Mary Diviney, Anne Dormoy, Katia Gagne, Brenda Gibson, Maria Gilleece, David Gottlieb, John Gribben, Tayfun Güngör, Mike Haagenson, Cathie Hart, Rhonda Holdsworth, Ian Humphreys, Yoshihisa Kodera, Mickey Koh, Hélène Labussière-Wallet, Arjan C Lankester, Neubery Lardy, Sarah Lawson, Xavier Leleu, Stephen MacKinnon, Ram Malladi, Steven GE Marsh, Murray Martin, Neema P Mayor, I Grant McQuaker, Ellen Meijer, Satoko Morishima, Emmanouil Nikolousis, Kim Orchard, Jacob Passweg, Amit Patel, Katherine Patrick, Béatrice Pedron, Andy Peniket, Julia Perry, Eefke Petersen, Victoria Potter, Mike Potter, Rachel Protheroe, Nicole Raus, Carmen Ruiz de Elvira, Nigel Russell, Nicholaas PM Schaap, Urs Schanz, Harry Schouten, Roderick Skinner, John Snowden, Eric Spierings, Colin Steward, Eleni Tholouli, Alycia Thornton, Marcel Tilanus, Arnold van de Meer, Hendrik Veelkens, Paul Veys, Narelle Watson, Lyanne Weston, Keith Wilson, Marie Wilson, Robert Wynn, József Zsiros, University of Washington [Seattle], Harvard University [Cambridge], Frederick National Laboratory for Cancer Research (FNLCR), Uppsala Universitet [Uppsala], PathWest Murdoch / Fiona Stanley Hospital [Perth, WA, Australia] (PMFSH), Etablissement français du sang - Auvergne-Rhône-Alpes (EFS), Fred Hutchinson Cancer Research Center [Seattle] (FHCRC), Medical College of Wisconsin [Milwaukee] (MCW), Memorial Sloane Kettering Cancer Center [New York], Royal Free Hospital [London, UK], Center for International Blood and Marrow Transplant Research [Minneapolis, MN, USA] (CIBMTR), Aichi Medical University School of Medicine [Nagakute, Aichi, Japan] (AMUSM), Leiden University Medical Centre [Leyde, Pays-Bas], Leiden University, Geneva University Hospital (HUG), International Histocompatibility Working Group in Hematopoietic Cell Transplantation: Effie W Petersdorf, Mary Carrington, Colm O'hUigin, Mats Bengtsson, Dianne De Santis, Valerie Dubois, Ted Gooley, Mary Horowitz, Katharine Hsu, J Alejandro Madrigal, Martin Maiers, Mari Malkki, Caroline McKallor, Yasuo Morishima, Machteld Oudshoorn, Stephen Spellman, Jean Villard, Phil Stevenson, Jane Apperley, Peter Bardy, Ghislaine Bernard, Yves Bertrand, Adrian Bloor, Chiara Bonini, Stephane Buhler, Laura Bungener, Helen Campbell, Kristina Carlson, Ben Carpenter, Anne Cesbron, Christian Chabannon, Yves Chalandon, Jeremy Chapman, Réda Chebel, Patrice Chevallier, Gerda Choi, Matt Collin, Jan J Cornelissen, Charles Crawley, Lloyd D'Orsogna, Jean-Hugues Dalle, Eric Deconinck, Muriel DeMatteis, Mary Diviney, Anne Dormoy, Katia Gagne, Brenda Gibson, Maria Gilleece, David Gottlieb, John Gribben, Tayfun Güngör, Mike Haagenson, Cathie Hart, Rhonda Holdsworth, Ian Humphreys, Yoshihisa Kodera, Mickey Koh, Hélène Labussière-Wallet, Arjan C Lankester, Neubery Lardy, Sarah Lawson, Xavier Leleu, Stephen MacKinnon, Ram Malladi, Steven Ge Marsh, Murray Martin, Neema P Mayor, I Grant McQuaker, Ellen Meijer, Satoko Morishima, Emmanouil Nikolousis, Kim Orchard, Jacob Passweg, Amit Patel, Katherine Patrick, Béatrice Pedron, Andy Peniket, Julia Perry, Eefke Petersen, Victoria Potter, Mike Potter, Rachel Protheroe, Nicole Raus, Carmen Ruiz de Elvira, Nigel Russell, Nicholaas Pm Schaap, Urs Schanz, Harry Schouten, Roderick Skinner, John Snowden, Eric Spierings, Colin Steward, Eleni Tholouli, Alycia Thornton, Marcel Tilanus, Arnold van de Meer, Hendrik Veelkens, Paul Veys, Narelle Watson, Lyanne Weston, Keith Wilson, Marie Wilson, Robert Wynn, József Zsiros, Leiden University Medical Center (LUMC), GAGNE, Katia, CCA - Cancer Treatment and quality of life, AII - Inflammatory diseases, Hematology, CCA - Cancer biology and immunology, Petersdorf, E. W., Carrington, M., O'Huigin, C., Bengtsson, M., De Santis, D., Dubois, V., Gooley, T., Horowitz, M., Hsu, K., Madrigal, J. A., Maiers, M. J., Malkki, M., Mckallor, C., Morishima, Y., Oudshoorn, M., Spellman, S. R., Villard, J., Stevenson, P., Maiers, M., Spellman, S., Apperley, J., Bardy, P., Bernard, G., Bertrand, Y., Bloor, A., Bonini, C., Buhler, S., Bungener, L., Campbell, H., Carlson, K., Carpenter, B., Cesbron, A., Chabannon, C., Chalandon, Y., Chapman, J., Chebel, R., Chevallier, P., Choi, G., Collin, M., Cornelissen, J. J., Crawley, C., D'Orsogna, L., Dalle, J. -H., Deconinck, E., Dematteis, M., Diviney, M., Dormoy, A., Gagne, K., Gibson, B., Gilleece, M., Gottlieb, D., Gribben, J., Gungor, T., Haagenson, M., Hart, C., Holdsworth, R., Humphreys, I., Kodera, Y., Koh, M., Labussiere-Wallet, H., Lankester, A. C., Lardy, N., Lawson, S., Leleu, X., Mackinnon, S., Malladi, R., Marsh, S. G., Martin, M., Mayor, N. P., Mcquaker, I. G., Meijer, E., Morishima, S., Nikolousis, E., Orchard, K., Passweg, J., Patel, A., Patrick, K., Pedron, B., Peniket, A., Perry, J., Petersen, E., Potter, V., Potter, M., Protheroe, R., Raus, N., Ruiz de Elvira, C., Russell, N., Schaap, N. P., Schanz, U., Schouten, H., Skinner, R., Snowden, J., Spierings, E., Steward, C., Tholouli, E., Thornton, A., Tilanus, M., van de Meer, A., Veelkens, H., Veys, P., Watson, N., Weston, L., Wilson, K., Wilson, M., Wynn, R., Zsiros, J., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: DA TI Staf (9), University of Zurich, and Petersdorf, Effie W

Subjects
Oncology, Male, Hematopoietic Stem Cell Transplantation/methods, [SDV]Life Sciences [q-bio], 2720 Hematology, Graft vs Host Disease, Histocompatibility Testing, 0302 clinical medicine, Graft vs Host Disease/genetics, immune system diseases, unrelated donor, Exons/genetics, graft-versus-host disease, Medicine, ddc:616, Hematopoietic Stem Cell Transplantation, Exons, Hematology, Middle Aged, 3. Good health, [SDV] Life Sciences [q-bio], surgical procedures, operative, 030220 oncology & carcinogenesis, Histocompatibility, HLA-B Antigens/genetics, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, EXPRESSION, Adult, medicine.medical_specialty, Adolescent, [SDV.IMM] Life Sciences [q-bio]/Immunology, 610 Medicine & health, Human leukocyte antigen, Lower risk, Risk Assessment, Article, Graft vs Host Disease/genetics/immunology, 03 medical and health sciences, Internal medicine, Journal Article, Humans, Retrospective Studies, RECEPTOR, business.industry, MORTALITY, RECOGNITION, Retrospective cohort study, Odds ratio, medicine.disease, Transplantation, Graft-versus-host disease, hematopoietic-cell transplantation, SEQUENCE-DERIVED PEPTIDES, 10036 Medical Clinic, HLA-B Antigens, 10032 Clinic for Oncology and Hematology, Multivariate Analysis, RESIDUES, HLA-B leader, business, 030215 immunology
Abstract

Background: The success of unrelated haemopoietic cell transplantation (HCT) is limited by graft-versus-host disease (GVHD), which is the main post-transplantation challenge when HLA-matched donors are unavailable. A sequence dimorphism in exon 1 of HLA-B gives rise to leader peptides containing methionine (Met; M) or threonine (Thr; T), which differentially influence natural killer and T-cell alloresponses. The main aim of the study was to evaluate the role of the leader dimorphism in GVHD after HLA-B-mismatched unrelated HCT. Methods: We did a retrospective cohort study of 33 982 patients who received an unrelated HCT done in Australia, Europe, Japan, North America, and the UK between Jan 1, 1988, and Dec 31, 2016. Data were contributed by participants of the International Histocompatibility Working Group in Hematopoietic Cell Transplantation. All cases were included and there were no exclusion criteria. Multivariate regression models were used to assess risks associated with HLA-A, HLA-B, HLA-C, HLA-DRB1, and HLA-DQB1 mismatching. Among the 33 982 transplantations, the risks of GVHD associated with HLA-B M and T leaders were established in 17 100 (50·3%) HLA-matched and 1457 (4·3%) single HLA-B-mismatched transplantations using multivariate regression models. Leader frequencies were defined in 2 004 742 BeTheMatch US registry donors. Findings: Between Jan 20, 2017, and March 11, 2019, we assessed 33 982 HCTs using multivariate regression models for the role of HLA mismatching on outcome. Median follow-up was 1841 days (IQR 909–2963). Mortality and GVHD increased with increasing numbers of HLA mismatches. A single HLA-B mismatch increased grade 3–4 acute GVHD (odds ratio [OR] 1·89, 95% CI 1·53–2·33; p

Published
2021

3. Allogeneic hematopoietic cell transplantation with cord blood versus mismatched unrelated donor with post-transplant cyclophosphamide in acute myeloid leukemia

Author

Jaime Sanz, Patrice Ceballos, Fabio Ciceri, Hélène Labussière-Wallet, Ludmila S. Zubarovskaya, Frédéric Baron, Edouard Forcade, Mohamad Mohty, Jan J. Cornelissen, Bhagirathbhai Dholaria, Jürgen Kuball, Anna De Grassi, Annalisa Ruggeri, Myriam Labopin, Didier Blaise, Arnon Nagler, Patrice Chevallier, Bipin N. Savani, Dholaria, B., Labopin, M., Sanz, J., Ruggeri, A., Cornelissen, J., Labussiere-Wallet, H., Blaise, D., Forcade, E., Chevallier, P., Grassi, A., Zubarovskaya, L., Kuball, J., Ceballos, P., Ciceri, F., Baron, F., Savani, B. N., Nagler, A., Mohty, M., Vanderbilt University Medical Center [Nashville], Vanderbilt University [Nashville], Centre International des greffes [CHU Saint-Antoine] (EBMT), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), IRCCS Ospedale Pediatrico Bambino Gesù [Roma], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Hospices Civils de Lyon (HCL), Centre de Recherche en Cancérologie de Marseille (CRCM), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Centre hospitalier universitaire de Nantes (CHU Nantes), Azienda Ospedaliera Ospedale Papa Giovanni XXIII [Bergamo, Italy], Pavlov First Saint Petersburg State Medical University [St. Petersburg], University Medical Center [Utrecht], Hôpital Lapeyronie [Montpellier] (CHU), Ospedale San Raffaele, Centre Hospitalier Universitaire de Liège (CHU-Liège), Chaim Sheba Medical Center, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'hématologie clinique et de thérapie cellulaire [CHU Saint-Antoine], Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Gestionnaire, Hal Sorbonne Université, and Hematology

Subjects
Male, Cancer Research, Transplantation Conditioning, Cord blood transplantation, [SDV]Life Sciences [q-bio], Gastroenterology, Graft-versus-host disease, 0302 clinical medicine, Medicine, RC254-282, Acute leukemia, education.field_of_study, Hematology, Human leukocyte antigen, Incidence (epidemiology), Hematopoietic Stem Cell Transplantation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Allogeneic hematopoietic cell transplantation, Middle Aged, 3. Good health, [SDV] Life Sciences [q-bio], Leukemia, Myeloid, Acute, Oncology, 030220 oncology & carcinogenesis, Cord blood, Female, Cord Blood Stem Cell Transplantation, Post-transplant cyclophosphamide, Unrelated Donors, medicine.drug, Peripheral blood stem cell, Adult, medicine.medical_specialty, Disease relapse, Cyclophosphamide, Adolescent, Population, Mismatched donor, Cord blood unit, 03 medical and health sciences, Young Adult, SDG 3 - Good Health and Well-being, Internal medicine, Humans, Diseases of the blood and blood-forming organs, Bone marrow, education, Molecular Biology, Aged, Retrospective Studies, Acute myeloid leukemia, Toxicity, business.industry, Research, medicine.disease, Transplantation, RC633-647.5, business, 030215 immunology
Abstract

Background Allogeneic hematopoietic cell transplantation (allo-HCT) using a mismatched unrelated donor (MMUD) and cord blood transplantation (CBT) are valid alternatives for patients without a fully human leukocyte antigen (HLA)-matched donor. Here, we compared the allo-HCT outcomes of CBT versus single-allele-mismatched MMUD allo-HCT with post-transplant cyclophosphamide (PTCy) in acute myeloid leukemia. Methods Patients who underwent a first CBT without PTCy (N = 902) or allo-HCT from a (HLA 9/10) MMUD with PTCy (N = 280) were included in the study. A multivariate regression analysis was performed for the whole population. A matched-pair analysis was carried out by propensity score-based 1:1 matching of patients (177 pairs) with known cytogenetic risk. Results The incidence of grade II–IV and grade III–IV acute graft-versus-host disease (GVHD) at 6 months was 36% versus 32% (p = 0.07) and 15% versus 11% (p = 0.16) for CBT and MMUD cohorts, respectively. CBT was associated with a higher incidence of graft failure (11% vs. 4%, p p p p = 0.05), which resulted in worse leukemia-free survival (LFS) (HR = 1.68, 95% CI 1.34–2.12, p p p p = 0.052) and chronic GVHD (p = 0.69) did not differ significantly between the cohorts. These results were confirmed in a matched-pair analysis. Conclusions CBT was associated with lower LFS, OS, and GRFS due to higher NRM, compared to MMUD allo-HCT with PTCy. In the absence of a fully matched donor, 9/10 MMUD with PTCy may be preferred over CBT.

Published
2021

4. Comparing outcomes of a second allogeneic hematopoietic cell transplant using HLA-matched unrelated versus T-cell replete haploidentical donors in relapsed acute lymphoblastic leukemia: a study of the Acute Leukemia Working Party of EBMT

Author

Johanna Tischer, Arne Brecht, Tobias Gedde-Dahl, Thomas Valerius, Eolia Brissot, Didier Blaise, Mohamad Mohty, Mohamed A. Kharfan-Dabaja, Bipin N. Savani, Arnon Nagler, Jürgen Kuball, Annalisa Ruggeri, José Luis Díez-Martín, Fabio Benedetti, Tsila Zuckerman, Emanuele Angelucci, Christoph Schmid, Sebastian Giebel, Hélène Labussière-Wallet, Dolores Caballero, Martin Bornhäuser, Jaime Sanz, Victoria T Potter, Ali Bazarbachi, Benedetto Bruno, Myriam Labopin, Fabio Ciceri, Jürgen Finke, Riitta Niittyvuopio, Kharfan-Dabaja, M. A., Labopin, M., Bazarbachi, A., Ciceri, F., Finke, J., Bruno, B., Bornhauser, M., Gedde-Dahl, T., Labussiere-Wallet, H., Niittyvuopio, R., Valerius, T., Angelucci, E., Brecht, A., Caballero, D., Kuball, J., Potter, V., Schmid, C., Tischer, J., Zuckerman, T., Benedetti, F., Blaise, D., Diez-Martin, J. L., Sanz, J., Ruggeri, A., Brissot, E., Savani, B. N., Giebel, S., Nagler, A., Mohty, M., Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Adult, Male, medicine.medical_specialty, T cell replete, Lymphoblastic Leukemia, T-Lymphocytes, Population, Graft vs Host Disease, [SDV.CAN]Life Sciences [q-bio]/Cancer, Human leukocyte antigen, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Clinical endpoint, Humans, education, ComputingMilieux_MISCELLANEOUS, Retrospective Studies, Transplantation, Acute leukemia, education.field_of_study, Hematopoietic cell, business.industry, Hematopoietic Stem Cell Transplantation, Hematology, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, medicine.anatomical_structure, [SDV.IMM.IA]Life Sciences [q-bio]/Immunology/Adaptive immunology, 030220 oncology & carcinogenesis, Bone marrow, business, Unrelated Donors, 030215 immunology
Abstract

Optimal donor choice for a second allogeneic hematopoietic cell transplant (allo-HCT) in relapsed acute lymphoblastic leukemia (ALL) remains undefined. We compared outcomes using HLA-matched unrelated donors (MUD) versus haploidentical donors in this population. Primary endpoint was overall survival (OS). The MUD allo-HCT group comprised 104 patients (male = 56, 54%), median age 36 years, mostly (76%) with B-cell phenotype in complete remission (CR) (CR2/CR3 + = 76, 73%). The 61 patients (male = 38, 62%) in the haploidentical group were younger, median age 30 years (p = 0.002), had mostly (79%) a B-cell phenotype and the majority were also in CR at time of the second allo-HCT (CR2/CR3 + = 40, 66%). Peripheral blood stem cells was the most common cell source in both, but a significantly higher number in the haploidentical group received bone marrow cells (26% vs. 4%, p < 0.0001). A haploidentical donor second allo-HCT had a 1.5-fold higher 2-year OS (49% vs. 31%), albeit not statistically significant (p = 0.13). A longer time from first allo-HCT to relapse was associated with improved OS, leukemia-free survival, graft-versus-host disease-free-relapse-free survival, and lower cumulative incidences of relapse and non-relapse mortality. Results suggest no major OS difference when choosing either a MUD or haploidentical donor for ALL patients needing a second allo-HCT.

Published
2020

5. Treosulfan or busulfan plus fludarabine as conditioning treatment before allogeneic haemopoietic stem cell transplantation for older patients with acute myeloid leukaemia or myelodysplastic syndrome (MC-FludT.14/L): a randomised, non-inferiority, phase 3 trial

Author

Christian Junghanß, Christoph Groth, Nadezda Basara, Sandra Grass, Anja Klein, Inken Hilgendorf, Dietger Niederwieser, Sabine Dressler, Domenico Russo, Matthias Stelljes, Miroslaw Markiewicz, Beate Hauptrock, Daniel Wolff, Christof Scheid, Hélène Labussière-Wallet, Ernst Holler, Wichard Vogel, Peter Dreger, Kerstin Schaefer-Eckart, Heidrun A. Mylius, Goetz Ulrich Grigoleit, Maria Caterina Micò, Joachim Baumgart, Jochen Casper, Fabio Ciceri, Thomas Luft, Dietrich W. Beelen, Anna Paola Iori, Alessandro Rambaldi, Gernot Stuhler, Péter Reményi, Maria Bieniaszewska, Marta Medeot, Tamás Masszi, Nils Rudolf Winkelmann, Udo Holtick, Jacopo Peccatori, Uwe Pichlmeier, Mauricette Michallet, Friedrich Stölzel, Eva Maria Wagner-Drouet, Fabio Benedetti, Stephan Mielke, Johannes Schetelig, Régis Peffault de Latour, Wolfgang Bethge, Georg Nikolaus Franke, Michael Tribanek, Monika Dzierzak-Mietla, Helge Menzel, Gérard Socié, Rudolf Trenschel, Gerald Wulf, Bertram Glass, Christina Grosse-Thie, Mareike Verbeek, Juergen Finke, Francesca Patriarca, Claudia Hemmelmann, Beelen, D. W., Trenschel, R., Stelljes, M., Groth, C., Masszi, T., Remenyi, P., Wagner-Drouet, E. -M., Hauptrock, B., Dreger, P., Luft, T., Bethge, W., Vogel, W., Ciceri, F., Peccatori, J., Stolzel, F., Schetelig, J., Junghanss, C., Grosse-Thie, C., Michallet, M., Labussiere-Wallet, H., Schaefer-Eckart, K., Dressler, S., Grigoleit, G. U., Mielke, S., Scheid, C., Holtick, U., Patriarca, F., Medeot, M., Rambaldi, A., Mico, M. C., Niederwieser, D., Franke, G. -N., Hilgendorf, I., Winkelmann, N. R., Russo, D., Socie, G., Peffault de Latour, R., Holler, E., Wolff, D., Glass, B., Casper, J., Wulf, G., Menzel, H., Basara, N., Bieniaszewska, M., Stuhler, G., Verbeek, M., Grass, S., Iori, A. P., Finke, J., Benedetti, F., Pichlmeier, U., Hemmelmann, C., Tribanek, M., Klein, A., Mylius, H. A., Baumgart, J., Dzierzak-Mietla, M., and Markiewicz, M.

Subjects
Adult, Male, medicine.medical_specialty, Transplantation Conditioning, Population, Medizin, Antineoplastic Agents, Treosulfan, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, education, Busulfan, Preparative Regimen, Aged, education.field_of_study, business.industry, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, Interim analysis, 3. Good health, Fludarabine, Transplantation, Regimen, Leukemia, Myeloid, Acute, 030220 oncology & carcinogenesis, Myelodysplastic Syndromes, Female, business, Vidarabine, 030215 immunology, medicine.drug
Abstract

Background: Further improvement of preparative regimens before allogeneic haemopoietic stem cell transplantation (HSCT) is an unmet medical need for the growing number of older or comorbid patients with acute myeloid leukaemia or myelodysplastic syndrome. We aimed to evaluate the efficacy and safety of conditioning with treosulfan plus fludarabine compared with reduced-intensity busulfan plus fludarabine in this population. Methods: We did an open-label, randomised, non-inferiority, phase 3 trial in 31 transplantation centres in France, Germany, Hungary, Italy, and Poland. Eligible patients were 18–70 years, had acute myeloid leukaemia in first or consecutive complete haematological remission (blast counts

Published
2020

6. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Patients with Therapy-Related Myeloid Neoplasm: A Study from the Chronic Malignancies Working Party of the EBMT

Author

Marie Robin, Uwe Platzbecker, Arnold Ganser, Dietrich W. Beelen, Jakob Passweg, Junfeng Wang, Patrick Hayden, Johan Maertens, Christoph Scheid, Amandine Charbonnier, Liesbeth C. de Wreede, Fabio Ciceri, Jürgen Finke, Martin Bornhäuser, Nicolaus Kroeger, Hélène Labussière-Wallet, Patrice Chevallier, Noel Milpied, Linda Koster, Didier Blaise, Francesca Bonifazi, Jan J. Cornelissen, Ibrahim Yakoub-Agha, Robin, M., Wang, J., Koster, L., Beelen, D. W., Bornhauser, M., Kroeger, N., Platzbecker, U., Finke, J., Ganser, A., Blaise, D., Ciceri, F., Maertens, J., Labussiere-Wallet, H., Chevallier, P., Passweg, J. R., Cornelissen, J. J., Milpied, N., Charbonnier, A., Bonifazi, F., de Wreede, L. C., Hayden, P., Scheid, C., and Yakoub-Agha, I.

Subjects
Oncology, medicine.medical_specialty, business.industry, medicine.medical_treatment, Immunology, Medizin, Cancer, Cell Biology, Hematology, Hematopoietic stem cell transplantation, medicine.disease, Biochemistry, Chemotherapy regimen, Lymphoma, Myeloid Neoplasm, Transplantation, Leukemia, Breast cancer, hemic and lymphatic diseases, Internal medicine, medicine, business
Abstract

Patients with t-MN have a poor prognosis with median overall survival < 1 year due to high risk features of the disease and refractoriness to chemotherapy. HSCT represents the only curative treatment. Outcome after HSCT has progressively improved over time with a last EBMT study showing a 2-year OS at 44% in patients with secondary leukemia (79% post MPN or MDS) (BBMT 2018: 1406). Previous large studies showed survival < 30% in patients transplanted for t-MN (Blood. 2010:1850; Haematologica 2009:542). We recently reported in patients transplanted for a leukemia arising from MDS, MPN and CMML that the primary disease impacts the outcome, particularly patients with a previous MPN had the worst outcome (BJH, 2019: 725). We report here outcome of patients who received HSCT for a t-MN (excluding post MDS, MPN and CMML) with the hypothesis that the primary cancer impacts the outcome. From EBMT registry, patients with MDS or AML occurring after a primary cancer who received a HSCT between 01/06 and 12/16 were included. OS and RFS were analyzed using Kaplan Meier curves and log-rank test, relapse and NRM were analyzed as competing risks with cumulative incidence curves and Gray's test. 2334 patients were identified. Primary cancers were CLL in 102, non-Hodgkin lymphoma (NHL) in 668, Hodgkin lymphoma (HL) in 235, plasma cell disease (PCD) in 111, breast cancer in 643 and other solid tumor (ST) in 575. 981 patients had MDS and 1353 had AML at time of transplantation. Performance status by Karnofsky score was 90 or higher in 1376 (59%) patients. 722 (31%) patients were transplanted from HLA matched sibling donor (SIB) and 843 (36%) received a myelo-ablative conditioning regimen (MAC). 1307 patients were in remission at time of transplantation: 29% of MDS and 76% of AML patients. Three-year OS and RFS were 34 and 32% respectively. OS was significantly better in patients with AML in CR (43%) than not in CR (21%). OS and DFS were impacted by the primary cancer: post NHL (30 and 27%), post HL (29 and 28%), post ST (34% for both), post breast cancer (41 and 37%), post CLL (34 and 31%) and post PCD (32 and 25%) (p The multiple variables models includes age, regimen intensity, donor type, Karnofsky score, t-MN category (AML in CR, AML not in CR, MDS) and the primary type of cancer. Patients with HL (HR: 1.36, p=0.005) or NHL (HR: 1.31, p=0.001) had a higher adjusted risk for OS than patients with other primary diseases. Other risk factors for OS were t-MN type (AML not in CR, HR: 1.45, AML in CR, HR: 0.76, MDS = reference, p Conclusion: A quarter to one third of patients with t-MN can be cured by HSCT which was influenced by type of t-MN and performance status. The type of primary cancer influenced also the outcome with lower mortality, especially NRM in patients with previous solid tumor or PCD as compared to patients with lymphoma. Disclosures Robin: Novartis Neovii: Research Funding. Beelen:Medac GmbH Wedel Germany: Consultancy, Honoraria. Kroeger:DKMS: Research Funding; Neovii: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Riemser: Research Funding; JAZZ: Honoraria; Sanofi-Aventis: Honoraria; Novartis: Honoraria, Research Funding; Medac: Honoraria. Platzbecker:Celgene: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria. Finke:Riemser: Honoraria, Other: research support, Speakers Bureau; Neovii: Honoraria, Other: research support, Speakers Bureau; Medac: Honoraria, Other: research support, Speakers Bureau. Blaise:Pierre Fabre medicaments: Honoraria; Molmed: Consultancy, Honoraria; Sanofi: Honoraria; Jazz Pharmaceuticals: Honoraria. Chevallier:Daiichi Sankyo: Honoraria; Incyte: Consultancy, Honoraria; Jazz Pharmaceuticals: Honoraria.

Published
2019

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