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Article ; Online: Transplantation for myelofibrosis patients in the ruxolitinib era: a registry study from the Société Francophone de Greffe de Moelle et de Thérapie Cellulaire.

Villar, Sara / Chevret, Sylvie / Poire, Xavier / Joris, Magalie / Chevallier, Patrice / Bourhis, Jean-Henri / Forcade, Edouard / Chantepie, Sylvain / Beauvais, David / Raus, Nicole / Bay, Jacques-Olivier / Loschi, Michael / Devillier, Raynier / Duléry, Remy / Ceballos, Patrice / Rubio, Marie Thérèse / Servais, Sophie / Nguyen, Stephanie / Robin, Marie

Bone marrow transplantation

2024

Abstract: In this SFGM-TC registry study, we report the results after stem cell transplantation (HSCT) in 305 myelofibrosis patients, in order to determine potential risk factors associated with outcomes, especially regarding previous treatment with ruxolitinib. A ...

Abstract	In this SFGM-TC registry study, we report the results after stem cell transplantation (HSCT) in 305 myelofibrosis patients, in order to determine potential risk factors associated with outcomes, especially regarding previous treatment with ruxolitinib. A total of 102 patients were transplanted from an HLA-matched-sibling donor (MSD), and 143 patients received ruxolitinib. In contrast with previous studies, our results showed significantly worse outcomes for ruxolitinib patients regarding overall survival (OS) and non-relapse mortality (NRM), especially in the context of unrelated donors (URD). When exploring reasons for potential confounders regarding the ruxolitinib effect, an interaction between the type of donor and the use of ATG was found, therefore subsequent analyses were performed separately for each type of donor. Multivariable analyses did not confirm a significant negative impact of ruxolitinib in transplantation outcomes. In the setting of URD, only age and Fludarabine-Melphalan (FM) conditioning were associated with increased NRM. For MSD, only Karnoksfy <70% was associated with reduced OS. However, a propensity score analysis showed that ruxolitinib had a negative impact on OS but only in non-responding patients, consistent with previous data. To conclude, with all the precautions due to confounders and bias, ruxolitinib itself does not appear to increase mortality after HSCT.
Language	English
Publishing date	2024-03-21
Publishing country	England
Document type	Journal Article
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-024-02268-5
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Article ; Online: Use of letermovir in umbilical cord blood transplantation based on risk scores.

Rivera Franco, Monica M / Rafii, Hanadi / Volt, Fernanda / Kenzey, Chantal / Cappelli, Barbara / Scigliuolo, Graziana Maria / Rocha, Vanderson / Raus, Nicole / Dalle, Jean-Hugues / Chevallier, Patrice / Robin, Marie / Rubio, Marie Thérèse / Ruggeri, Annalisa / Gluckman, Eliane

Blood advances

2023 Volume 7, Issue 16, Page(s) 4315–4318

MeSH term(s)	Cord Blood Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation ; Acetates ; Risk Factors
Chemical Substances	letermovir (1H09Y5WO1F) ; Acetates
Language	English
Publishing date	2023-06-05
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2023010573
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Article ; Online: Lettre type pour les comptes rendus « CAR-T Cells » : recommandations de la Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC).

Broussais, Florence / Vasseur, Alyette / Karam, Micheline / Chaillou, Delphine / Pereira, Maguy / Yakoub-Agha, Ibrahim / Raus, Nicole

Bulletin du cancer

2021 Volume 108, Issue 12S, Page(s) S82–S86

Abstract: Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first representatives of a new class of gene therapies produced by ex-vivo genetic modification of human autologous T lymphocytes, now using viral vectors. In 2020, there are ... ...

Title translation	A standardized medical report template for CAR T-Cell therapy patients: Guidelines of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC).
Abstract	Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first representatives of a new class of gene therapies produced by ex-vivo genetic modification of human autologous T lymphocytes, now using viral vectors. In 2020, there are three independent CAR-T cell databases in France: DESCAR-T (database supported by LYSARC, GRAALL and the IFM), ProMISe (EBMT database) and ATIH (database of the Agence Technique de l'Information sur l'Hospitalisation). Only the EBMT database is common to France and the French-speaking countries that are members of the SFGM-TC. In 2019, a workshop was held to draft a manual for entering data specific to CAR-T cells in the EBMT ProMISe database. As a follow-up to this article, we present a medical report template containing all the data required to enter the data of patients treated with CAR-T in the EBMT registry, in the CRF of the DESCAR-T registry and in the ATIH registry. This document aims to improve the completeness and quality of the data while optimizing data entry time.
MeSH term(s)	Antineoplastic Agents, Immunological/therapeutic use ; Biological Products/therapeutic use ; Databases, Factual/standards ; Follow-Up Studies ; France ; Humans ; Immunotherapy, Adoptive ; Medical Records/standards ; Receptors, Antigen, T-Cell/therapeutic use ; Receptors, Chimeric Antigen ; Societies, Medical ; T-Lymphocytes/transplantation
Chemical Substances	Antineoplastic Agents, Immunological ; Biological Products ; Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen ; tisagenlecleucel (Q6C9WHR03O) ; axicabtagene ciloleucel (U2I8T43Y7R)
Language	French
Publishing date	2021-04-28
Publishing country	France
Document type	Guideline ; Journal Article
ZDB-ID	213270-9
ISSN	1769-6917 ; 0007-4551
ISSN (online)	1769-6917
ISSN	0007-4551
DOI	10.1016/j.bulcan.2021.01.023
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Article ; Online: HLA haplotype frequencies and diversity in patients with hemoglobinopathies.

Scigliuolo, Graziana M / Boukouaci, Wahid / Cappelli, Barbara / Volt, Fernanda / Rivera Franco, Monica M / Dhédin, Nathalie / de Latour, Regis Peffault / Devalck, Christine / Dalle, Jean-Hugues / Castelle, Martin / Hermine, Olivier / Chardin, Marie Ouachée / Poiré, Xavier / Brichard, Bénédicte / Paillard, Catherine / Rafii, Hanadi / Kenzey, Chantal / Wu, Ching-Lien / Bouassida, Jihène /

Robin, Marie / Raus, Nicole / Rocha, Vanderson / Ruggeri, Annalisa / Gluckman, Eliane / Tamouza, Ryad

EJHaem

2023 Volume 4, Issue 4, Page(s) 963–969

Abstract: The genetic diversity of the human leukocyte antigen (HLA) system was shaped by evolutionary constraints exerted by environmental factors. Analyzing HLA diversity may allow understanding of the underlying pathways and offer useful tools in transplant ... ...

Abstract	The genetic diversity of the human leukocyte antigen (HLA) system was shaped by evolutionary constraints exerted by environmental factors. Analyzing HLA diversity may allow understanding of the underlying pathways and offer useful tools in transplant setting. The aim of this study was to investigate the HLA haplotype diversity in patients with sickle cell disease (SCD,
Language	English
Publishing date	2023-08-04
Publishing country	United States
Document type	Journal Article
ISSN	2688-6146
ISSN (online)	2688-6146
DOI	10.1002/jha2.763
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Article ; Online: Salvage haploidentical or cord-blood allogeneic stem cell transplantation after a prior alternative allograft in hematologic malignancies: A retrospective study from the SFGM-TC.

Cavalieri, Doriane / Rubio, Marie-Thérèse / Corriger, Alexandrine / Pereira, Bruno / Cabrespine, Aurélie / Robin, Marie / Labussière-Wallet, Hélène / Calleja, Anne / Forcade, Edouard / Chevallier, Patrice / Guillerm, Gaelle / Berceanu, Ana / Bulabois, Claude-Eric / Maillard, Natacha / Nguyen, Stéphanie / Raus, Nicole / Schoemans, Hélène / Bay, Jacques-Olivier / Ravinet, Aurélie

European journal of haematology

2022 Volume 110, Issue 1, Page(s) 40–49

Abstract: Background: Haploidentical (haplo-) donors and cord-blood (CB) stem cells provide alternative transplant options in patients lacking an HLA-matched donor. In case of relapse or graft failure after a first alternative allogeneic hematopoietic stem cell ... ...

Abstract	Background: Haploidentical (haplo-) donors and cord-blood (CB) stem cells provide alternative transplant options in patients lacking an HLA-matched donor. In case of relapse or graft failure after a first alternative allogeneic hematopoietic stem cell transplant (HSCT), a second alternative HSCT (HSCT2) is rarely considered due to a high risk of toxicity. Methods: A retrospective French multicentre study was performed, including patients with hematologic malignancies who underwent two consecutive HSCT from alternative donors. All data were exported from the national ProMISE database between 2000 and 2016. Results: Forty-three patients (61.4%) received a CB-HSCT2 and 27 (38.6%) a haplo-HSCT2. Indications for HSCT were graft failure (51.4%) or disease progression (48.6%). Two-years probabilities of overall survival, progression-free survival and toxicity-related mortality were 18.5%, 17.8% and 55.8%, respectively. In multivariate analysis, complete remission status at HSCT2 and year of HSCT2 ≥ 2012 were significantly associated with a better outcome (with respectively hazard ratio [HR] = 0.42, p = .002 and HR = 0.5, p = .051). Conclusions: Neither the indication of HSCT2 nor the source of stem cell was more advantageous towards overall patient survival. A salvage haploidentical or cord-blood stem cell transplantation is a high-risk procedure, that may be considered for patients achieving a complete remission before receiving the second HSCT.
MeSH term(s)	Humans ; Retrospective Studies ; Graft vs Host Disease/diagnosis ; Graft vs Host Disease/etiology ; Neoplasm Recurrence, Local ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/methods ; Hematologic Neoplasms/diagnosis ; Hematologic Neoplasms/therapy ; Allografts
Language	English
Publishing date	2022-10-17
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	392482-8
ISSN	1600-0609 ; 0902-4441
ISSN (online)	1600-0609
ISSN	0902-4441
DOI	10.1111/ejh.13868
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Article ; Online: Modalités de capture des anomalies cytogénétiques et moléculaires pour la leucémie aiguë, le myélome multiple, le syndrome myélodysplasique, le syndrome myéloprolifératif et le syndrome myélodysplasique/myéloprolifératif : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC).

Raus, Nicole / Karam, Micheline / Chebel, Réda / Dantin, Carole / Pereira, Maguy / Wallart, Anne / Yakoub-Agha, Ibrahim / Srour, Micha

Bulletin du cancer

2019 Volume 107, Issue 1S, Page(s) S52–S61

Abstract: In an effort to standardize hematopoietic stem cell allograft procedures, the Francophone bone marrow transplantation and Cell Therapy Society (SFGM-TC) organized the 9th Allograft Harmonization Practice Workshop in Lille in September 2018. The purpose ... ...

Title translation	How to capture cytogenetic and molecular abnormalities into ProMISe database for hematological malignancies: Guidelines from the francophone society of bone marrow transplantation and cellular therapy (SFGM-TC).
Abstract	In an effort to standardize hematopoietic stem cell allograft procedures, the Francophone bone marrow transplantation and Cell Therapy Society (SFGM-TC) organized the 9th Allograft Harmonization Practice Workshop in Lille in September 2018. The purpose of these workshops is to propose a consensual attitude to the centers that wish it. In this workshop, we discuss how to capture the cytogenetic and molecular abnormalities of acute leukaemias, myelomas, myelodysplasias, myeloproliferative syndromes and myelodysplastic/myeloproliferative syndromes in the database common to all European transplant centers called ProMISe and managed by the European Society for Blood and Marrow Transplantation (EBMT). The complexity of cytogenetic and molecular data makes it difficult to enter data into the ProMISe registry. This workshop proposes a tool for input assistance, in tabular form by pathology. The main recommendation for the karyotype remains that of the complex karyotype that must be entered in "Full caryotype". Concerning the molecular anomalies, it is necessary to enter all the items proposed by ProMISe. In reviewing all the sheets proposed by ProMise, we note the absence of some relevant elements that can be added later.
MeSH term(s)	Abnormal Karyotype ; Biomarkers, Tumor ; Chromosome Aberrations ; Data Collection/methods ; Data Management ; Databases, Genetic ; Europe/epidemiology ; Forms and Records Control ; Hematologic Neoplasms/epidemiology ; Hematologic Neoplasms/genetics ; Humans ; Myelodysplastic Syndromes/epidemiology ; Myelodysplastic Syndromes/genetics ; Myeloproliferative Disorders/epidemiology ; Myeloproliferative Disorders/genetics
Chemical Substances	Biomarkers, Tumor
Language	French
Publishing date	2019-10-12
Publishing country	France
Document type	Consensus Development Conference ; Journal Article ; Practice Guideline
ZDB-ID	213270-9
ISSN	1769-6917 ; 0007-4551
ISSN (online)	1769-6917
ISSN	0007-4551
DOI	10.1016/j.bulcan.2019.07.007
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Article ; Online: Codage HLA dans ProMISe : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC).

Raus, Nicole / Faucher, Catherine / Kennel, Anne / Pereira, Maguy / Veron, Cécile / Yakoub-Agha, Ibrahim / Loiseau, Pascale

Bulletin du cancer

2017

Abstract: As part of the 7th Annual francophone workshop series on the harmonization of clinical practices in allogeneic stem cell transplantation held in Lille in September 2016, our workgroup discussed how transplant centers might follow a collective approach to ...

Title translation	HLA coding in ProMISe: Guidelines from the Francophone Society of bone marrow transplantation and cellular therapy (SFGM-TC).
Abstract	As part of the 7th Annual francophone workshop series on the harmonization of clinical practices in allogeneic stem cell transplantation held in Lille in September 2016, our workgroup discussed how transplant centers might follow a collective approach to coding data. This was done mainly by analyzing the study results found in the literature that do not provide clear answers. In addition, we discuss practical ways of coding for both donor and recipient HLA typing in the European bone marrow transplantation database called ProMISe which is managed by the European Society for Blood and Marrow Transplantation (EBMT).
Language	French
Publishing date	2017-11-08
Publishing country	France
Document type	English Abstract ; Journal Article
ZDB-ID	213270-9
ISSN	1769-6917 ; 0007-4551
ISSN (online)	1769-6917
ISSN	0007-4551
DOI	10.1016/j.bulcan.2017.06.021
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Article ; Online: Saisie des données des patients faisant l’objet d’un traitement par cellules CAR-T : recommandations de la Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC).

Vasseur, Alyette / Karam, Micheline / Chaillou, Delphine / Colonnese, Elodie / Dantin, Carole / Latiere, Christelle / Meziane, Youcef / Pereira, Maguy / Yakoub-Agha, Ibrahim / Chabannon, Christian / Raus, Nicole

Bulletin du cancer

2019 Volume 107, Issue 12S, Page(s) S178–S184

Abstract: Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first two approved drug products that belong to of a new class of therapies manufactured through an industrial process that includes the ex vivo genetic modification of human ... ...

Title translation	Reporting data of patients receiving CAR T cell therapy into the EBMT registry: Guidelines of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC).
Abstract	Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first two approved drug products that belong to of a new class of therapies manufactured through an industrial process that includes the ex vivo genetic modification of human autologous T lymphocytes with viral vectors. Since CAR-T Cells qualify as gene therapy medicinal products, there is a requirement for long-term (15 years) follow-up of treated patients. As part of a global initiative aiming at a better use of continental registries to study the outcome of homogeneous groups of patients, EMA issued a positive opinion on the use of the EBMT registry to capture LTFU of patients treated with CAR-T Cell in EU Member states. The use of a European registry will provide a global view of this new field across EU countries and across diverse indications, and bears advantages over the use of registries dedicated to specific categories of diseases, or national registries. This is an important asset to fully measure the medical value of these innovative therapies in real-life conditions, and assess whether pricing is fully justified. To fulfill EMA requirements, as well as requirements from Pharma companies, EBMT has designed a new Cellular Therapy Med-A form that allows to capture the essential information on the administered drug product, disease and patient. Registering patients and capturing follow-up data is already possible in Promise, and will be made easier when the full migration of the EBMT database from Promise to MACRO is completed in the forthcoming weeks. Negotiations are ongoing with all interested parties including patients to define in which conditions data will be accessed and analyzed; the underlying principle is to favor rather than restrict the use of data, with a view to build cooperative projects involving relevant cooperative groups and professional associations. Here, we present practical recommendations issued by SFGM-TC to help data managers capture information related to patients treated with CAR-T Cells.
MeSH term(s)	Antigens, CD19/therapeutic use ; Bone Marrow Transplantation ; Congresses as Topic ; Data Collection/methods ; Databases, Factual ; Europe ; Follow-Up Studies ; Humans ; Immunotherapy, Adoptive/statistics & numerical data ; Receptors, Antigen, T-Cell/therapeutic use ; Registries ; Societies, Medical ; Time Factors
Chemical Substances	Antigens, CD19 ; Receptors, Antigen, T-Cell ; tisagenlecleucel (Q6C9WHR03O) ; axicabtagene ciloleucel (U2I8T43Y7R)
Language	French
Publishing date	2019-12-09
Publishing country	France
Document type	Journal Article ; Practice Guideline
ZDB-ID	213270-9
ISSN	1769-6917 ; 0007-4551
ISSN (online)	1769-6917
ISSN	0007-4551
DOI	10.1016/j.bulcan.2019.10.003
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Article ; Online: Mainly Post-Transplant Factors Are Associated with Invasive Aspergillosis after Allogeneic Stem Cell Transplantation: A Study from the Surveillance des Aspergilloses Invasives en France and Société Francophone de Greffe de Moelle et de Thérapie Cellulaire.

Robin, Christine / Cordonnier, Catherine / Sitbon, Karine / Raus, Nicole / Lortholary, Olivier / Maury, Sébastien / Peffault de la Tour, Regis / Bretagne, Stéphane / Bastuji-Garin, Sylvie

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2018 Volume 25, Issue 2, Page(s) 354–361

Abstract: Invasive aspergillosis (IA) occurs in up to 23% of allogeneic hematopoietic stem cell transplantation (HSCT) patients. Although transplant procedures have changed over time, more late cases of IA are being observed. The objective of this study was to ... ...

Abstract	Invasive aspergillosis (IA) occurs in up to 23% of allogeneic hematopoietic stem cell transplantation (HSCT) patients. Although transplant procedures have changed over time, more late cases of IA are being observed. The objective of this study was to identify the pre- and post-transplant factors of IA in a large cohort of HSCT patients mainly transplanted with reduced-intensity conditioning. This multicenter, case-control study was carried out using data collected between 2005 and 2010 by the Surveillance des Aspergilloses Invasives en France program (Institut Pasteur, Paris) and the European Society for Blood and Marrow Transplantation ProMISe registry. Four control subjects without IA were individually matched to each case based on the center, patient age, and year of the transplant. We identified 185 cases of probable and proven IA and 651 control subjects. The median date of IA after the transplant was 133 days, with 35 cases (19%) of early IA (before day 40), 33 cases (18%) of late IA (days 40 to 100), and 117 cases (63%) cases of very late IA (after day 100). In the multivariate analysis early IA was significantly associated with a lack of engraftment, whereas late and very late IA were significantly associated with more than grade II acute graft-versus-host disease (GVHD); very late IA was also significantly associated with relapse and secondary neutropenia. Two-thirds of IA cases occurred more than 100 days after HSCT with different risk factors from those occurring earlier. Prophylactic strategies should consider the specific risk factors for late and very late IA, especially GVHD, relapse after transplant, and secondary neutropenia.
MeSH term(s)	Acute Disease ; Adult ; Allografts ; Aspergillosis/epidemiology ; Aspergillosis/etiology ; Europe ; Female ; Graft vs Host Disease/epidemiology ; Graft vs Host Disease/etiology ; Graft vs Host Disease/microbiology ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Middle Aged ; Neutropenia/epidemiology ; Neutropenia/etiology ; Neutropenia/microbiology ; Prospective Studies ; Recurrence ; Registries ; Retrospective Studies ; Risk Factors ; Societies, Medical
Language	English
Publishing date	2018-09-27
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2018.09.028
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Article ; Online: Outcomes of refractory or relapsed Hodgkin lymphoma patients with post-autologous stem cell transplantation brentuximab vedotin maintenance: a French multicenter observational cohort study.

Marouf, Amira / Cottereau, Anne Segolene / Kanoun, Salim / Deschamps, Paul / Meignan, Michel / Franchi, Patricia / Sibon, David / Antoine, Clara / Gastinne, Thomas / Borel, Cecile / Hammoud, Mohammad / Sicard, Guillaume / Gille, Romane / Cavalieri, Doriane / Stamatoullas, Aspasia / Filliatre-Clement, Lauriane / Lazarovici, Julien / Chauchet, Adrien / Fornecker, Luc-Matthieu /

Amorin, Sandy / Rocquet, Mathieu / Raus, Nicole / Burroni, Barbara / Rubio, Marie Therese / Bouscary, Didier / Quittet, Philippe / Casasnovas, Rene Olivier / Brice, Pauline / Ghesquieres, Herve / Tamburini, Jérôme / Deau, Benedicte

Haematologica

2022 Volume 107, Issue 7, Page(s) 1681–1686

MeSH term(s)	Brentuximab Vedotin ; Hematopoietic Stem Cell Transplantation ; Hodgkin Disease/drug therapy ; Humans ; Immunoconjugates/therapeutic use ; Salvage Therapy ; Stem Cell Transplantation ; Transplantation, Autologous
Chemical Substances	Immunoconjugates ; Brentuximab Vedotin (7XL5ISS668)
Language	English
Publishing date	2022-07-01
Publishing country	Italy
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2021.279564
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