The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

NCT ID: NCT07113730

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2036-07-31

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.

Conditions

Chronic Myelomonocytic Leukemia (CMML); Immune Reconstitution

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

immune reconstitution

Intervention Type: OTHER

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

Prospective cohort

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

immune reconstitution

Intervention Type: OTHER

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

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.

immune reconstitution

Intervention Type: OTHER

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

Interventions

immune reconstitution

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

the 960th Hospital of the People's Liberation Army Joint Logistics Support Force

UNKNOWN

Sponsor Role: collaborator

Shanghai General Hospital, ShanghaiJiao Tong University School of Medicine

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice President of Peking University Institute of Hematology Affiliation: Peking University People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Mengtong Zang, MD

Role: CONTACT

zangztong@163.com

18744579871

Other Identifiers

2025PHB073-001

Identifier Type: -

Identifier Source: org_study_id