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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
| 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. |
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| Prospective cohort | Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. |
| |
| Retrospective/Prospective cohort | Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immune reconstitution | Other | Detection of immune reconstitution in peripheral blood of patients by flow cytometry at 30-day intervals for 180 days post-transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune reconstitution | 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. | 180 days |
| Immunoglobulin levels | To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL). | 180 days |
| 2-year OS | To describe the incidence of 2-year OS | 2 years |
| 5-year PFS | To describe the incidence of 5-year PFS | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| cGVHD | To describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD) | 5 years |
| Bacterial infection | To describe the number of patients with bacterial infection detected in blood, stool, sputum, etc. after HSCT |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with confirmed chronic myelomonocytic leukemia (CMML)
Prerequisite criteria:
Supporting criteria :
Then, if the monocyte count is ≥1 × 109/L, one or more supporting criteria must be met, and if the monocyte count is ≥0.5 and <1 × 109/L, the first two supporting criteria must be met.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengtong Zang, MD | Contact | 18744579871 | zangztong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Hui Zhang, MD | Peking University Institute of Hematology, Peking University People's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074243 | Immune Reconstitution |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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| 5 years |
| Fungal infection | To describe the number of patients with fungal infection detected in blood, stool, sputum, etc. after HSCT | 5 years |
| Viral infection | To describe the number of patients with viral infection detected in blood, stool, sputum, etc. after HSCT | 5 years |
| aGVHD | To describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD) | 100 days |
| D054437 |
| Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |