Retrospective and Prospective Study on the Kinetics Profiling of Immune Reconstitution and Clinical Outcomes in CMML Following Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Immune reconstitution
研究概览
简要总结
Chronic myelomonocytic leukemia (CMML) is a clonal hematopoietic malignancy with poor prognosis. Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Immune reconstitution (IR) is critical for improving HSCT efficacy and quality of life among survivors, yet its dynamic impact on survival and complications like chronic graft-versus-host disease (cGVHD) in CMML is poorly defined. This study aimed to investigate the dynamics of IR following HSCT in patients with CMML and evaluate its impact on post-transplant clinical outcomes.
详细描述
Chronic myelomonocytic leukemia (CMML) is a myeloid malignancy exhibiting clinical and morphological features of both myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPNs). The optimal treatment regimen remains unclear, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is currently the only known potentially curative treatment option. During allo-HSCT, the recipient's immune system undergoes reconstitution from donor-derived cells. Timely engraftment and functional recovery of the donor immune system are critical for patient recovery and long-term survival post-transplantation. While HSCT can achieve durable remission, it is associated with significant life-threatening complications, primarily mediated by rapidly reconstituted immune components. However, the cellular dynamics underlying the re-establishment of immune homeostasis between donor and recipient compartments post-HSCT remain poorly characterized. This study aims to delineate the kinetics of immune reconstitution (IR) in CMML patients following allo-HSCT, dynamically analyze its impact on clinical outcomes and prognosis, and ultimately develop and optimize immunotherapeutic strategies to enhance overall survival and improve quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of CMML following HSCT
- •Patients treated at Peking University People's Hospital since January 1, 2005
排除标准
- •Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders
- •Patients deemed ineligible for the study by investigators
结局指标
主要结局
Immune reconstitution
时间窗: 180 days
To quantify the percentages（%） of lymphocyte subsets (including CD19+ B cells, CD3+ T cells, CD4+ T cells, CD8+ T cells, CD3+CD8+CD28+ T cells, CD3+CD4+CD28+ T cells, CD4+CD45RA+ naive T cells, CD4+CD45RO+ memory T cells, CD4+CD25+CD45RA+ naive regulatory T cells, CD4+CD25+CD45RO+ memory regulatory T cells, and CD4+CD25+ total regulatory T cells) relative to nucleated cells using flow cytometry.
Immunoglobulin levels
时间窗: 180 days
To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL).
2-year OS
时间窗: 2 years
To describe the incidence of 2-year OS
5-year PFS
时间窗: 5 years
To describe the incidence of 5-year PFS
次要结局
- cGVHD(5 years)
- Bacterial infection(5 years)
- Fungal infection(5 years)
- Viral infection(5 years)
- aGVHD(100 days)
研究者
Xiao Hui Zhang
Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital
Peking University People's Hospital