SFGM-TC

  • 文章类型: English Abstract
    嵌合抗原受体T细胞(CAR-T细胞)疗法已成为几种血液学的标准治疗方法,并且是对实体恶性肿瘤或选定的非恶性自身免疫性疾病的有希望的治疗方法。这种治疗后的血液学并发症非常常见,大多数患者在CAR-T细胞注射后至少出现一次血细胞减少。这些不良事件的管理不是标准化的,并且代表活跃的研究和未满足的临床需求的领域。这次协调研讨会,聚集了一组分析这个话题的专家,已被设想用于优化患有CAR-T细胞后血液学毒性的患者的管理。根据文献中的数据,这些实用建议旨在协调涉及这些患者管理的法语中心的实践.
    Chimeric antigen receptor T cell (CAR-T cell) therapy has become a standard-of-care for several hematological and a promising treatment for solid malignancies or for selected non-malignant autoimmune disorders. Hematological complications following this treatment are very common with the majority of patients experiencing at least one cytopenia after CAR-T cell injections. The management of these adverse events is not standardized and represents an area of active research and unmet clinical needs. This harmonization workshop, gathering a group of experts who analyzed this topic, has been conceived for the optimization of the management of patients presenting with post-CAR-T cell hematological toxicities. Based on the data present in the literature, these practical recommendations were made to harmonize the practices of Francophone centers involved in the management of these patients.
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  • 文章类型: English Abstract
    儿科的做法-特别是在照顾低体重儿童时-不同于成人的做法,由于儿科患者的手术数量很少,这对相关医护人员的实践培训和再培训具有实际意义,根据适应训练和验证持续能力的需要。必须进行专门的培训,以确保儿童和工作人员在收集期间和之后的安全,以及确保收集的细胞产品的高质量,并且其符合取决于其预期用途的预定义规格。低体重和极低体重儿童在许多程序和临床方面值得特别注意:静脉通路的性质和质量,以确保细胞分离器的正常运行,与儿童的总血液体积相比,与体外血液体积的相对重要性相关的血液动力学波动的管理,柠檬酸盐毒性的风险和临床表现,在手术过程中压力的最小化,可能包括但不限于药物镇静。处理这些方面所需的全部能力很少出现在一个单一的医疗保健专业人员团队中;它通常需要从收集设施中汲取的专业知识的紧密结合,儿科,可能还有儿科重症监护病房,无论是来自同一机构还是来自不同机构。互动必须在一份文件中形式化,准确描述哪一类行为者对每一类行为负责(处方、decisions),根据他们最初的资格,特定能力,和从属关系。
    Practice of pediatric aphereses - in particular when caring for low-weight children - differs from the practice of adult aphereses, since pediatric aphereses represent low numbers of procedures, which has practical implications in terms of practical training and retraining for involved healthcare personnel, as needed for habilitation and validation of ongoing competencies. A specific training is mandatory in order to ensure both the child and the staff safety during and after collection, as well as ensure high quality of the collected cell product and that its meets predefined specifications that depend on its intended use. Low and very low-weight children deserve a particular attention for a number of procedural and clinical aspects: the nature and quality of venous accesses to ensure proper operation of the cell separator, management of hemodynamic fluctuations in relation with the relative importance of the extracorporeal blood volume as compared to the total blood volume of the child, risks and clinical manifestations of citrate toxicity, minimization of stress during the procedure that may include but is not limited to pharmacological sedation. The full spectrum of competencies needed to deal with these aspects is rarely present within a single team of healthcare professionals; it most often requires the tight combination of expertise drawing from the collection facility, the pediatric department and possibly the pediatric intensive care unit ward, whether from the same or from different institutions. Interactions must be formalized in a document that accurately describes which category of actors is responsible for each category of acts (prescriptions, decisions), depending on their initial qualifications, specific competencies, and affiliations.
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  • 文章类型: English Abstract
    供体的选择是异基因造血干细胞移植的基本要素。在没有HLA匹配相关供体的情况下,考虑选择不相关的捐赠者,并且是目前在实践中使用的最常见的同种异体供体类型。当多个供体可用时,选择考虑了许多标准,特别是在部分匹配的情况下。该讲习班的目的是协助选择无关的捐助者,与文献中的最新数据保持一致。
    The selection of a donor is an essential element in allogeneic hematopoietic stem cell transplantation. In the absence of an HLA-matched related donor, the selection of an unrelated donor is considered, and is currently the most common type of allogenic donor used in practice. Many criteria are considered for the selection when multiple donors are available, particularly in case of partial match. The aim of this workshop is to assist in the selection of an unrelated donor, in keeping with recent data from the literature.
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  • 文章类型: English Abstract
    异基因造血细胞移植(allo-HCT)后的复发仍然是一个主要问题,因为它与不良生存率有关。在这种情况下,第二allo-HCT是有效选项。在法语国家骨髓移植和细胞治疗协会(SFGM-TC)的第13届年度协调研讨会上,一个指定的工作组审查了文献,以更新上一次研讨会(2016年)期间提出的第二项allo-HCT建议.第二次allo-HCT的主要适应症仍然是最初的血液系统恶性肿瘤的复发。疾病状态;完全缓解(CR),首次allo-HCT>6个月后的复发时间对第二次allo-HCT后患者的总生存率有积极影响。捐赠者变更是一个有效的选择,特别是如果在首次单倍体相合或错配的allo-HCT后白血病细胞上存在HLA丢失。推荐降低强度的调理,而对于增殖性疾病患者,序贯方案是一个合理的选择。即使尚未停止免疫抑制治疗,也建议在第60天进行血液学恢复后的移植后维持策略。低甲基化剂,和靶向治疗如抗FLT3,抗BCL2,抗IDH1/2,TKI,抗TP53,抗CD33,抗CD19,抗CD22,抗CD30,检查点抑制剂,和CAR-T细胞可以用作移植的桥梁或作为第二个allo-HCT的替代治疗。
    Relapse after allogeneic hematopoietic cell transplantation (allo-HCT) remains a major concern because it is associated with poor survival. A second allo-HCT is a valid option in this situation. During the 13th annual harmonization workshops of the francophone Society of bone marrow transplantation and cellular therapy (SFGM-TC), a designated working group reviewed the literature in order to update the second allo-HCT recommendations elaborated during the previous workshop (2016). The main indication for a second allo-HCT remains relapse of initial hematologic malignancy. Disease status; complete remission (CR), and relapse time after the first allo-HCT>6 months impact positively the overall survival of patients after the second allo-HCT. Donor change is a valid option, particularly if there is HLA loss on leukemic cells after a first haploidentical or following a mismatched allo-HCT is documented. Reduced intensity conditioning is recommended, while a sequential protocol is a reasonable option in patients with proliferative disease. A post-transplant maintenance strategy after hematological recovery is recommended as soon as day 60, even if the immunosuppressive treatment has not yet been stopped. Hypomethylating agents, and targeted therapies such as anti FLT3, anti BCL2, anti-IDH1/2, TKI, anti-TP53, anti-CD33, anti-CD19, anti-CD22, anti-CD30, check point inhibitors, and CAR-T cells can be used as a bridge to transplant or as an alternative treatment to the second allo-HCT.
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  • 文章类型: English Abstract
    在资源有限的国家,急性淋巴细胞白血病(ALL)患者的管理取决于预后分层的方法,可用的治疗和后勤。在法语国家骨髓移植和细胞治疗协会(SFGM-TC)的第12届年度协调研讨会上,一个指定的工作组回顾了文献,以便详细阐述针对该疾病的异基因造血细胞移植(Allo-HCT)的统一指南.常规不良预后因素可用于确定首次缓解时allo-HCT的指征。如果有的话,缺乏HLA匹配的相关供体的患者可以用单倍体相同的供体allo-HCT进行同种异体移植。如果TBI不可用,可以使用基于化疗的预处理方案。因为找到具有全身照射能力的放射治疗部门的可能性很低。对于费城染色体阳性(Phi+)ALL的患者,建议将移植后酪氨酸激酶抑制剂作为系统的维持策略。自体HCT对于微小残留病阴性的Phi+ALL患者是可选的,没有资格获得allo-HCT的人。患有难治性/复发性疾病的患者预后不良,这凸显了在未来获得新疗法的重要性,例如:blinatumumab,伊托珠单抗,和CAR-T细胞。
    Management of acute lymphoblastic leukemia (ALL) patients in countries with limited resources depends on the means of prognostic stratification, available treatment and logistics. During the 12th annual harmonization workshops of the francophone Society of bone marrow transplantation and cellular therapy (SFGM-TC), a designated working group reviewed the literature in order to elaborate unified guidelines for allogeneic hematopoietic cell transplantation (Allo-HCT) in this disease. Conventional poor prognostic factors can be used to determine the indication of allo-HCT in first remission. Patients lacking a HLA-matched related donor can be allografted with a haploidentical donor allo-HCT if available. Chemotherapy based conditioning regimen can be used if TBI is not available, because the probability to find a radiotherapy department with the capacity for total body irradiation is low. For patients with Philadelphia chromosome positive (Phi+) ALL, post-transplantation tyrosine kinase inhibitors as a systematic maintenance strategy is recommended. Autologous HCT is optional for Phi+ ALL patients with negative minimal residual disease, who not eligible for allo-HCT. Patients with refractory/relapsed disease have a poor prognosis which highlights the importance of acquiring in the future new therapies such as: blinatumumab, inotuzumab, and CAR-T cells.
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  • 文章类型: Journal Article
    异基因造血干细胞移植(allo-HSCT)后,一个人的性生活和情感生活受到极大影响。患者和护理人员对此话题的讨论并不多。Physical,内分泌和生殖器慢性移植物抗宿主病(cGVHD)相关疾病是多发性的,并与心理障碍交织在一起。法语国家骨髓移植和细胞治疗协会(SFGM-TC)已发布建议,以更好地对allo-HCT后的女性接受者进行妇科监测。还以问题和答案的形式向患者提供了一本患者手册,以促进患者和护理人员之间的讨论,并改善移植后性生活和情感生活的管理。
    A person\'s sexual and emotional life is greatly impacted after allogeneic hematopoietic stem cell transplantation (allo-HSCT). This topic is not addressed very much by patients and caregivers. Physical, endocrine and genital chronic graft versus host disease (cGVHD)-related disorders are multiple and intertwined with psychological disorders. The Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) has issued recommendations for a better gynecological monitoring of female recipients after allo-HCT. A patient booklet was also offered to patients in the form of questions and answers to facilitate discussions between patients and caregivers and to improve the management of sexual and emotional life after transplant.
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  • 文章类型: English Abstract
    Hematopoietic cell transplantation (HCT) is the curative treatment for many malignant and non-malignant blood disorders and some solid cancers. However, transplant procedures are considered tertiary level care requiring a high degree of technicality and expertise and generating very high costs for hospital structures in developing countries as well as for patients without health insurance. During the 11th annual harmonization workshops of the francophone Society of bone marrow transplantation and cellular therapy (SFGM-TC), a designated working group reviewed the literature in order to elaborate unified guidelines, for developing the transplant activity in emerging countries. Access to infrastructure must comply with international standards and therefore requires a hospital system already in place, capable of accommodating and supporting the HCT activity. In addition, the commitment of the state and the establishment for the financing of the project seems essential.
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  • 文章类型: English Abstract
    In the attempt to harmonize practices and to create a national CAR T-cells patient follow-up care logbook, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) worked on the design of a common national care logbook during the eleventh annual workshops of practice harmonization. The purpose of this logbook was to explain the different phases of the treatment with CAR T-cells and to allow useful monitoring for the patient. This logbook can be also helpful for the different healthcare professionals involved in the patient care. This national logbook will provide important information to the patients undergoing CAR T-cell therapy. In addition to the information booklets already in use, the national logbook simplifies patient follow-up by recording various medical appointments and possible adverse events. This work has been based on tools that had already been put in place by different CAR T-cell centers. This national logbook represents a common \"base\" and is prepared in the form of index cards to be classified using dividers in a binder. Therefore, the national care logbook will be adaptable for local procedures and guidelines of each center.
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  • 文章类型: English Abstract
    Chimeric antigen receptor (CAR) T cells are a new class of anti-cancer therapy that involves manipulating autologous or allogeneic T cells to express a CAR directed against a membrane antigen. In Europe, tisagenlecleucel (Kymriah™) has marketing authorization for the treatment of relapsed / refractory acute lymphoblastic leukemia (ALL) in children and young adults, in addition to the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL); the marketing authorization for axicabtagene ciloleucel (Yescarta™) is for the treatment of relapsed / refractory high-grade B-cell lymphoma and for the treatment of primary mediastinal B-cell lymphoma. Both cell products are genetically modified autologous T cells directed against CD19. These recommendations, drawn up by a working group of the Francophone Society of Bone Marrow transplantation and cellular Therapy (SFGM-TC) relate to the management of patients and the supply chain: medium-term complications, in particular cytopenias and B-cell aplasia, nursing and psychological supportive care. In another work, we will address long-term monitoring, post-marketing authorization pharmacovigilance and issues relating to JACIE and regulatory authorities. These recommendations are not prescriptive; their aim is to provide guidelines for the use of this new therapeutic approach. The purpose of this workshop is to outline the organizational aspects of this new therapeutic approach.
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  • 文章类型: Journal Article
    The Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) organises annual workshops in an attempt to harmonise clinical practices among different francophone transplantation centres. The SFGM-TC harmonisation workshops aim at establishing practical guidelines, on the one hand, from data from the literature and international recommendations and, on the other hand, by consensus in the absence of formally proven data. The sexual and emotional life of allogeneic hematopoietic stem cells transplanted (HSCT) patients is often very impacted and remains a subject relatively little addressed by patients and caregivers. This article is an update from a previous workshop and is accompanied by a patient booklet, which will be included in the post allograft follow-up workbook published by the SFGM-TC. The purpose of these two documents is to facilitate discussions between patients and caregivers on the subject and to present proposals for follow-up and tools to better manage the sexual and emotional life of allotransplanted patients.
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