Chronic Myelomonocytic Leukemia (CMML), Immune Reconstitution
Conditions
Keywords
Chronic Myelomonocytic Leukemia (CMML), immune reconstitution, allogeneic hematopoietic stem cell transplantation (allo-HSCT)
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.
Interventions
Detection of immune reconstitution in peripheral blood of patients by flow cytometry at 30-day intervals for 180 days post-transplantation.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients with confirmed diagnosis of CMML following HSCT 2. Patients treated at Peking University People's Hospital since January 1, 2005
Exclusion criteria
1. Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders 2. Patients deemed ineligible for the study by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Immunoglobulin levels | 180 days | To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| cGVHD | 5 years | To describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD) |
| aGVHD | 100 days | To describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD) |
| 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 |