The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes
- Conditions
- Chronic Myelomonocytic Leukemia (CMML)Immune Reconstitution
- Registration Number
- NCT07113730
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Patients with confirmed diagnosis of CMML following HSCT
- Patients treated at Peking University People's Hospital since January 1, 2005
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune reconstitution 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, while peripheral blood monocyte counts(\*10\^9/L) and serum immunoglobulin levels (IgG, IgA, IgM) (mg/dL) were concurrently assessed.
2-year OS 2 years To describe the incidence of 2-year OS
5-year PFS 5 years To describe the incidence of 5-year PFS
- Secondary Outcome Measures
Name Time Method cGVHD 5 years To describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD)
Bacterial infection 5 years To describe the number of patients with bacterial infection detected in blood, stool, sputum, etc. after HSCT
Fungal infection 5 years To describe the number of patients with fungal infection detected in blood, stool, sputum, etc. after HSCT
Viral infection 5 years To describe the number of patients with viral infection detected in blood, stool, sputum, etc. after HSCT
aGVHD 100 days To describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD)