Adriana Mendes de Quadros Cavilha

Hematopoietic cell transplantation is a data-driven field, and reporting to outcomes registries has become a common practice worldwide. However, comprehensive transplant data collection requires dedicated professionals who can accurately capture data, follow international guidelines, and maintain reliable databases for the evaluation of transplant outcomes. This article describes the development and evolution of the Brazilian Data Managers Working Group (GTGD) and its contributions to professional education, collaborative networking, registry implementation, data quality improvement, and scientific engagement in hematopoietic cell transplantation and cellular therapy in Brazil. The transition from single-center reporting to the establishment of a national transplant registry required collaboration among centers, partnership between the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) and the Center for International Blood and Marrow Transplant Research (CIBMTR), and the development of the GTGD to ensure the sustainability of this effort. The GTGD originated from a grassroots collaboration among data managers and transplant centers seeking to address limited professional recognition, inconsistent reporting practices, and restricted access to specialized training. Supported by collaboration with the SBTMO and CIBMTR, the initiative evolved into a nationally coordinated network. Over the decade, the GTGD promoted structured education, knowledge sharing, professional development, operational support, standardized data-management practices, quality-improvement initiatives, and scientific collaboration. In parallel, participation in the national multicenter protocol expanded to 95 centers, with 51 centers reporting data to the CIBMTR by 2025. The group also developed educational resources, supported benchmarking and cellular therapy reporting, strengthened national and international collaboration, and increased the visibility and professional identity of data managers within transplant programs. This experience demonstrates how coordinated engagement, continuous education, institutional collaboration, and professional advocacy can contribute to the development of national registry infrastructure and the generation of reliable real-world evidence in hematopoietic cell transplantation and cellular therapy.

The development of the Brazilian Registry of Hematopoietic Cell Transplantation (Registro Brasileiro de Transplantes de Células Hematopoieticas), in collaboration with the Center for International Blood and Marrow Transplant Research (CIBMTR), continues to provide a comprehensive assessment of hematopoietic cell transplantation (HCT) activity and outcomes in Brazil. In this study, we report an updated analysis of national transplant activity. Brazilian transplant centers report their data to the CIBMTR using the FormsNet3 platform, and data are returned to the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (Sociedade Brasileira de Terapia Celular e Transplante de Medula Óssea) through the Data Back to Centers (DBtC) tool. Data from patients who underwent HCT from 2015 to 2025 in Brazilian centers were extracted from the CIBMTR. Descriptive analyses were performed using patient-, disease-, and transplant-related variables, and overall survival was estimated using the Kaplan–Meier method. A total of 15,586 HCTs were included (7,507 autologous and 8,079 allogeneic). For survival analyses, 9,150 patients who underwent a first HCT from 2015 to 2023 were analyzed, with a median follow-up of 35 months. The number of reporting centers increased over time, reaching 51 centers during the study period. Acute leukemias remained the most common indication for allogeneic HCT, while multiple myeloma and lymphomas predominated in autologous HCT. In recent years, mismatched related donors have accounted for the largest proportion of allogeneic transplants. Bone marrow was the main graft source in pediatric patients, whereas peripheral blood predominated in adults. Infections were the most frequent cause of death within the first 100 days after HCT, while primary disease was the leading cause beyond 100 days. Survival patterns varied according to disease characteristics and transplantrelated factors, with lower survival estimates observed in patients transplanted with advanced disease stages. Comparisons with the United States Summary Slides suggest both similarities and differences in transplant activity and outcomes, which should be interpreted with caution given variations in data structure, patient characteristics, and risk stratification.

The Brazilian Hematopoietic Cell Transplantation and Cellular Therapy (HCT-CT/BR) Registry depends on data manager (DM) training to ensure sustainability, for which it is essential to standardize processes. The objectives of this study were to describe the development of a support manual for Brazilian DMs reporting to the Center for International Blood and Marrow Transplant Research and to present quality assessment results. The descriptive study (Feb–Aug 2024) included structuring, content creation, and dissemination of the manual. Survey assessed satisfaction. The manual was launched at the XXVIII Brazilian Society of Cellular Therapy and Bone Marrow Transplantation Congress. Thirty-nine professionals rated it 9.3/10 for satisfaction and 9.4/10 for recommendation. A manual is crucial for standardizing processes and ensuring data quality, offering clear and up-to-date guidance.

Systematic evaluation of hematopoietic cell transplantation (HCT) outcomes is essential to improve clinical practice and meet international quality standards. In Brazil, the partnership between the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) and the Center for International Blood and Marrow Transplant Research (CIBMTR) has advanced national data reporting and benchmarking through the Hematopoietic Cell Transplantation Brazilian Registry (HCTBR). This study reports outcomes from 11,210 first HCTs (5,984 allogeneic; 5,226 autologous) performed between 2012 and 2023 across 44 Brazilian centers. Median recipient age was 29 years for allogeneic and 53 years for autologous transplants. Acute leukemias predominated among allogeneic cases, while multiple myeloma was the most common indication for autologous HCT. Two-year overall survival was 82.0% for autologous and 59.8% for allogeneic transplants, with variation by donor type (matched related 61.8%, mismatched related 54.0%, unrelated 63.3%). Two-year non-relapse mortality was 8.0% and 21.6% for autologous and allogeneic transplants, respectively. The cumulative incidence of grade II–IV acute graft-versus-host disease (GVHD) at two years was 29.9%, with chronic GVHD incidence of 29.5%. Two-year relapse incidence was 24.1% for allogeneic and 25.8% for autologous HCT. Despite challenges within the Brazilian healthcare system, these outcomes align with international registry data. Adequate data completeness supports the robustness of these findings. Our results highlight the quality of Brazilian transplant programs and underscore the value of standardized outcome monitoring to foster continuous improvement. Strengthening center participation, follow-up, and data management remains critical to maintaining registry quality and enhancing patient care.

The development of the Brazilian Registry of Hematopoietic Cell Transplantation (HCT) in collaboration with the Center for International Blood and Marrow Transplant Research (CIBMTR) continues to provide a comprehensive assessment of the activity and general outcomes of HCT in Brazil. In this paper, we report an update of such activity. Brazilian transplant centers report their data to the CIBMTR, using the FormsNet3 platform. The data then return to the Brazilian Cellular Therapy and Bone Marrow Transplant Society (SBTMO) through the Data Back to Centers (DBtC) tool. Data from patients who received an HCT from 2012 to 2024 from Brazilian centers were extracted from the CIBMTR. A descriptive analysis was carried out using patient, disease and transplant-specific variables and overall survival analysis using the Kaplan Meier method. A total of 14,331 patients were eligible for this study (6,583 autologous and 7,748 allogeneic HCTs). The number of reporting centers increased from 40 to 45 during the period. The most common HCT indication in Brazil for allogeneic HCT was AML, with 171 HCTs per year and, for autologous HCT, multiple myeloma, with 273 HCTs per year. Among allogeneic HCT, in the last 4 years, mismatched related donor was the main source of donors. Regarding the graft source for allogeneic HCTs, bone marrow (BM) was the most frequent among pediatric HCTs, while peripheral blood (PB) was the most used in adults. Infections were the leading cause of death in the first 100 days after all types of HCTs. Patients with acute leukemia who underwent HCT at an advanced disease stage had lower survival rates compared to those at earlier stages. Despite the differences in the number of cases and follow-up time, the results in this study were similar to those presented in the United States (USA) Summary Slides.

Chimeric antigen receptor T-cells (CAR T cells) are genetically modified cellular immunotherapies approved for standard of care treatment of patients with lymphoma and leukemia worldwide. Here we report the initial activity in Brazilian centers through the collaboration between the Brazilian Cellular Therapy and Bone Marrow Transplant Society (SBTMO) and Center for International Blood and Marrow Transplant Research (CIBMTR). A total of 38 patients who received CAR T cells between 2020 and 2023. The median age was 47 years (range 4-77). Indications include Non-Hodgkin Lymphoma (NHL; 26 cases; 68%), Acute Lymphoblastic Leukemia (ALL; 9 cases; 24%), and Multiple Myeloma (MM; 3 cases; 8%). 84% (75% - 24 NHL cases and 25% - 8 ALL cases) were commercial. This report demonstrates the initial implementation of CAR T cells in Brazil among centers that report to the SBTMO/CIBMTR. This infrastructure will assist in further capturing the activity, assessing the outcomes, and complying with regulatory requirements.

The development of the Brazilian Registry of Hematopoietic Cell Transplantation in collaboration with the Center for International Blood and Marrow Transplant Research (CIBMTR) allowed for an assessment of the activity and general outcomes of transplants in Brazil. Here, we report an updated activity. Brazilian transplant centers report their data to the CIBMTR, using the FormsNet3 platform. Information returns to Brazilian Cellular Therapy and Bone Marrow Transplant Society (SBTMO) through the Data Back to Centers (DBtC) tool. Data from patients who received an HCT from 2012 to 2023 from Brazilian centers were extracted from CIBMTR. Descriptive analysis was carried out by patient-, disease- and transplant-specific variables and overall survival analysis using Kaplan Meyer. A total of 12,230 patients were eligible for this study (5,573 autologous and 6,657 allogeneic transplants). The number of reporting centers increased from 40 to 44 during the period. The most common HCT indication in Brazil is AML for allogeneic HCT with 152 transplants year and multiple myeloma for autologous HCT with 245 transplants per year. Among allogeneic HCT, in the last 4 years, mismatched related donor was the main source of donors. Regarding the graft source for allogeneic transplants, BM was the most frequent among pediatric transplants, while PBSC was the most used in adults. Infections were the leading cause of death in the first 100 days after all types of transplants. Patients with acute leukemia who underwent HCT with advanced stage disease had lower survival rates compared to those at other stages. Despite the differences in the number of cases and follow-up time, the results in this study were similar to those presented in the United States (US) Summary Slides.

Since the first hematopoietic stem cell transplantation (HSCT) was performed at the Federal University Hospital (Curitiba, PR) in 1979, the number of centers offering this modality of treatment has increased. However, accessing comprehensive HSCT outcomes has become a challenge due to lack of an official Brazilian registry. The partnership between the Brazilian Cellular Therapy and Bone Marrow Transplant Society (SBTMO) and the Center for International Blood and Marrow Research (CIBMTR) was an important milestone in the establishment of the HSCT Brazilian registry (HSCTBR). By using CIBMTR’s Data Back to Center (DBtC) tool, we have gained insights into HSCT outcomes through the Brazilian Summary Slides. While understanding the country's transplant scenario is crucial, it is equally important for each center to assess their own outcomes. In order to help the Brazilian centers with the CIBMTR, the data manager of SBTMO working group has developed a business tool solution to facilitate this important task.

Objetivo: realizar a validação de conteúdo de protocolo de cuidados de enfermagem no pós-transplante de células-tronco hematopoiéticas pediátrico. Método: pesquisa metodológica, com a participação de juízes brasileiros (n=15), com emprego da técnica Delphi, em duas rodadas, entre janeiro 2019 e outubro de 2020. As sugestões dos juízes foram avaliadas em reuniões de consenso e acatadas. O Índice de Validade de Conteúdo, o coeficiente Kappa e o coeficiente alfa de Cronbach foram empregados na análise dos dados. Resultados: o protocolo de cuidados de enfermagem é dividido em três dimensões: psicobiológica, incluindo 30 problemas de enfermagem; psicossocial, englobando sete, psicoespiritual, com três problemas de enfermagem. Na segunda rodada de avaliação do protocolo, o coeficiente Kappa foi igual a 0,70, o coeficiente alfa de Cronbach foi de 0,94 e o Índice de Validade de Conteúdo geral foi de 0,98. Conclusão: o conteúdo do protocolo foi considerado válido. Essa tecnologia pode ser utilizada com segurança no cuidado à criança transplantada.