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The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

Retrospective and Prospective Study on the Kinetics Profiling of Immune Reconstitution and Clinical Outcomes in CMML Following Allogeneic Hematopoietic Stem Cell Transplantation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07113730
Enrollment
300
Registered
2025-08-11
Start date
2025-08-13
Completion date
2036-07-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelomonocytic Leukemia (CMML), Immune Reconstitution

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

OTHERimmune reconstitution

Detection of immune reconstitution in peripheral blood of patients by flow cytometry at 30-day intervals for 180 days post-transplantation.

Sponsors

The First Hospital of Jilin University
CollaboratorOTHER
the 960th Hospital of the People's Liberation Army Joint Logistics Support Force
CollaboratorUNKNOWN
Shanghai General Hospital, ShanghaiJiao Tong University School of Medicine
CollaboratorUNKNOWN
Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL

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

MeasureTime frameDescription
Immune reconstitution180 daysTo 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 levels180 daysTo test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL).
2-year OS2 yearsTo describe the incidence of 2-year OS
5-year PFS5 yearsTo describe the incidence of 5-year PFS

Secondary

MeasureTime frameDescription
cGVHD5 yearsTo describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD)
aGVHD100 daysTo describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD)
Bacterial infection5 yearsTo describe the number of patients with bacterial infection detected in blood, stool, sputum, etc. after HSCT
Fungal infection5 yearsTo describe the number of patients with fungal infection detected in blood, stool, sputum, etc. after HSCT
Viral infection5 yearsTo describe the number of patients with viral infection detected in blood, stool, sputum, etc. after HSCT

Contacts

Primary ContactMengtong Zang, MD
zangztong@163.com18744579871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026