The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

NCT07113730 | Not Yet Recruiting

• 1 other identifier: 2025PHB073-001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Myelomonocytic Leukemia (CMML); Immune Reconstitution

Keywords

Chronic Myelomonocytic Leukemia (CMML); immune reconstitution; allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• cGVHD

  5 years

• Bacterial infection

  5 years

• Fungal infection

  5 years

• Viral infection

  5 years

• aGVHD

  100 days

Study Arms (3)

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.

Other: immune reconstitution

Prospective cohort

Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort.

Other: immune reconstitution

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.

Other: immune reconstitution

Interventions

immune reconstitution OTHER

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

Prospective cohort; Retrospective cohort; Retrospective/Prospective cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed chronic myelomonocytic leukemia (CMML) Prerequisite criteria: 1. persistent of monocytosis in PB (absolute ≥0.5 × 109/L or relative ≥10%) 2. blast cell \<20% in PB and bone marrow, excluding chronic myeloid leukemia or other MPN. Supporting criteria : 1. dysplasia involving 1 or more myeloid lineages 2. the presence of acquired clonal cytogenetic or molecular abnormalities 3. abnormal partitioning of PB monocyte subsets (classical monocytes \>94%). The requirements for CMML diagnosis include prerequisite criteria that must be met in all patients. 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• The First Hospital of Jilin University: collaborator
• the 960th Hospital of the People's Liberation Army Joint Logistics Support Force: collaborator
• Shanghai General Hospital, ShanghaiJiao Tong University School of Medicine: collaborator

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Immune Reconstitution

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Xiao-Hui Zhang, MD

  Peking University Institute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengtong Zang, MD

CONTACT

18744579871; zangztong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 11, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): July 31, 2035
• Study Completion (Estimated): July 31, 2036
• Last Updated: August 15, 2025

Record last verified: 2025-08