The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

Peking University

Status: Not yet enrolling

Conditions: Chronic Myelomonocytic Leukemia (CMML); Immune Reconstitution

Treatments: Other: immune reconstitution

Study type: Observational

Funder types: Other

Identifiers

NCT07113730

2025PHB073-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Retrospective cohort

Description:

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.

Treatment:

Other: immune reconstitution

Prospective cohort

Description:

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

Treatment:

Other: immune reconstitution

Retrospective/Prospective cohort

Description:

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.

Treatment:

Other: immune reconstitution