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临床试验/NCT07823946
NCT07823946尚未招募不适用

Assesment of Upper Egypt Experience in Autologous Bone Marrow Transplantation of Patients With Hematological Malignancies: A Cohor Study

Assiut University0 个研究点目标入组 123 人开始时间: 2026年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
123
主要终点
PFS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Adult patients (≥18 years) with a confirmed diagnosis of a hematological malignancy.
  • 2.Patients undergoing their autologous hematopoietic stem cell transplantation (ASCT).
  • 3-willingness to participate in the study

排除标准

  • - 1.Patients undergoing allogeneic hematopoietic stem cell transplantation. 2.Patients with uncontrolled active infection or severe organ dysfunction that contraindicates transplantation.
  • 3.Patients with incomplete clinical data or who withdraw consent during the study period.

研究组 & 干预措施

Autologous bone marrow transplant patients

结局指标

主要结局

PFS

时间窗: through study completion, an average of 2 year

Clinical outcome of autologous hematopoietic stem cell transplantation, including overall survival (OS) and Progression-Free Survival (PFS).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham Askary

Assistant Lecturer of hematology, Department of Internal Medicine, Faculty of Medicine, Assiut University

Assiut University

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