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NCT Number: NCT07113730

The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

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.

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Key information

Conditions

Chronic Myelomonocytic Leukemia (CMML) Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune Reconstitution Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed diagnosis of CMML following HSCT
  • Patients treated at Peking University People's Hospital since January 1, 2005

Exclusion criteria

  • 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

Treatment and study plan

immune reconstitution

Other

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

Primary outcomes

  1. Immune reconstitution

    Time frame: 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.

  2. Immunoglobulin levels

    Time frame: 180 days

    To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL).

  3. 2-year OS

    Time frame: 2 years

    To describe the incidence of 2-year OS

  4. 5-year PFS

    Time frame: 5 years

    To describe the incidence of 5-year PFS

Secondary outcomes

  1. cGVHD

    Time frame: 5 years

    To describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD)

  2. Bacterial infection

    Time frame: 5 years

    To describe the number of patients with bacterial infection detected in blood, stool, sputum, etc. after HSCT

  3. Fungal infection

    Time frame: 5 years

    To describe the number of patients with fungal infection detected in blood, stool, sputum, etc. after HSCT

  4. Viral infection

    Time frame: 5 years

    To describe the number of patients with viral infection detected in blood, stool, sputum, etc. after HSCT

  5. aGVHD

    Time frame: 100 days

    To describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD)

Study contacts

Contact information is provided by the study sponsor or research team.

Mengtong Zang, MD

CONTACT

[email protected]

18744579871

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • The First Hospital of Jilin University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Aug 11, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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