Afonso Celso Vigorito

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.

Graft-versus-host disease (GvHD) remains the mainly cause of late non-relapse mortality following allogeneic hematopoietic cell transplantation. Advancements in novel immunosuppressive therapies and prophylactic regimens necessitate an update to current clinical guidance. This consensus provides updated evidence-based recommendations for GVHD prophylaxis, alongside the treatment of acute and chronic disease.

Objective: To describe CAR-T cell therapy activity and outcomes reported by Brazilian centers participating in the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO)/Center for International Blood and Marrow Transplant Research (CIBMTR) network between January 2020 and December 2025. Methods: Data from patients who received commercial or academic CAR-T cell therapies in Brazilian centers were extracted from the CIBMTR database. Participating centers reported data through the FormsNet3 platform, allowing standardized collection of patient, disease, and treatment-related variables. Descriptive analyses were performed, and overall survival (OS) was estimated using the Kaplan–Meier method. Results: A total of 219 CAR-T cell infusions were reported. The median age was 57 years (range, 4–83 years). The most common indications were non Hodgkin lymphoma (NHL) (146 patients, 67%), multiple myeloma (MM) (39 patients, 18%), acute lymphoblastic leukemia (ALL) (32 patients, 14%), and chronic lymphocytic leukemia (CLL) (2 patients, 1%). Commercial CAR-T products accounted for 89% of all treatments and were predominantly used for NHL (n = 135) and MM (n = 35). Most deaths were attributed to disease progression or relapse (n = 42), followed by infections (n = 14). After a median followup of 365 days, the 1-year OS was 63% (95% CI, 54–73%) among patients with NHL and 73% (95% CI, 57–93%) among patients with ALL. Conclusion: This report documents the implementation and rapid expansion of CAR-T cell therapy in Brazil among centers reporting to the SBTMO/CIBMTR network. The continued development of this collaborative infrastructure supports national monitoring of CAR-T activity, facilitates outcome assessment, and contributes to quality assurance, benchmarking initiatives, and compliance with national and international regulatory requirements.

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.

This study provides a national overview of hematopoietic cell transplantation (HCT) outcomes in the Brazil’s public healthcare network, using data consolidated in the Brazilian Registry of Hematopoietic Cell Transplantation and Cellular Therapy (RBTCH-TC). A total of 5,923 first HCTs performed between 2012 and 2024 across 19 public centers were analyzed. Median follow-up among survivors reached 24.5 months, reflecting recent improvements in follow-up completeness and data reliability within the registry. Overall survival, relapse, and non-relapse mortality (NRM) rates were generally consistent with international benchmarks, despite the resource limitations characteristic of a publicly funded system. NRM was concentrated in the first year after allogeneic HCT, whereas relapse remained the predominant cause of late mortality across both autologous and allogeneic procedures. Acute graft versus-host disease (GVHD) was more frequent among recipients of mismatched related and unrelated donors, while chronic GVHD occurred more often in matched related donor transplants. These findings highlight the complexity of transplant care in the public setting and underscore the importance of standardized data collection, integration across centers, and long-term surveillance to support continuous quality improvement. Strengthening national collaborative initiatives such as the RBTCH-TC remains essential for guiding evidence-based strategies and improving patient outcomes throughout Brazil’s public transplant network.