Assesment of Upper Egypt Experience in Autologous Bone Marrow Transplantation of Patients With Hematological Malignancies: A Cohor Study
Autologous hematopoietic stem cell transplantation (ASCT) is an important treatment for eligible patients with hematological malignancies, particularly multiple myeloma and relapsed lymphoma. Although advances in transplantation have improved outcomes, complications such as infections, febrile neutropenia, mucositis, delayed engraftment, organ toxicity, and relapse remain significant. This study aims to evaluate clinical outcomes and patient satisfaction after ASCT and identify factors associated with favorable or unfavorable transplant outcomes.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Hematological malignancies are a heterogeneous group of neoplastic disorders arising from the bone marrow and lymphoid tissues, including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, and selected leukemias. Despite substantial advances in chemotherapy, targeted therapies, and immunotherapy, relapse remains a major cause of treatment failure and disease-related mortality. Autologous hematopoietic stem cell transplantation (ASCT) has become an integral component of treatment for eligible patients by allowing the administration of high-dose chemotherapy followed by reinfusion of the patient's own hematopoietic stem cells to restore bone marrow function, thereby improving disease control and survival outcomes.
ASCT is considered the standard consolidation therapy for transplant-eligible patients with multiple myeloma and an effective salvage treatment for relapsed or refractory Hodgkin lymphoma and selected aggressive non-Hodgkin lymphomas. Advances in stem cell mobilization, cryopreservation techniques, conditioning regimens, antimicrobial prophylaxis, and supportive care have significantly improved engraftment rates while reducing transplant-related morbidity and mortality. However, complications such as febrile neutropenia, severe infections, mucositis, delayed hematopoietic recovery, organ toxicity, and disease relapse continue to adversely affect patient outcomes and quality of life.
Assessment of transplantation outcomes is essential to evaluate the effectiveness and safety of ASCT in routine clinical practice. Several factors, including patient age, disease status at transplantation, performance status, conditioning regimen, CD34⁺ cell dose, and post-transplant complications, may influence survival and treatment success. Therefore, this study aims to assess the clinical outcomes of ASCT and patient satisfaction among patients with hematological malignancies, as well as to identify factors associated with favorable and unfavorable transplant outcomes, thereby contributing to improved patient selection and optimization of transplant strategies.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
All consecutive adult patients with hematological malignancies who underwent autologous hematopoietic stem cell transplantation at the Bone Marrow Transplantation Unit, Assiut University Hospitals, during the study period and fulfilled the eligibility criteria.
Descripción
Inclusion Criteria:
- Adult patients (≥18 years) with a confirmed diagnosis of a hematological malignancy.
- Patients undergoing their autologous hematopoietic stem cell transplantation (ASCT).
- willingness to participate in the study
Exclusion Criteria:
- Patients undergoing allogeneic hematopoietic stem cell transplantation.
- Patients with uncontrolled active infection or severe organ dysfunction that contraindicates transplantation.
- Patients with incomplete clinical data or who withdraw consent during the study period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Autologous bone marrow transplant patients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PFS
Periodo de tiempo: through study completion, an average of 2 year
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Clinical outcome of autologous hematopoietic stem cell transplantation, including overall survival (OS) and Progression-Free Survival (PFS). |
through study completion, an average of 2 year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Autologous B.M. transplantatio
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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