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The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes

ConditionsChronic Myelomonocytic Leukemia (CMML)Immune Reconstitution
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with confirmed diagnosis of CMML following HSCT

Patients treated at Peking University People's Hospital since January 1, 2005

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • immune reconstitution

    Other intervention

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Retrospective cohort1 intervention
Group B: Prospective cohort1 intervention
Group C: Retrospective/Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
180 days
2

Immunoglobulin levels

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

Time frame
180 days
3

2-year OS

To describe the incidence of 2-year OS

Time frame
2 years
4

5-year PFS

To describe the incidence of 5-year PFS

Time frame
5 years

Secondary outcomes

1

cGVHD

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

Time frame
5 years
2

Bacterial infection

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

Time frame
5 years
3

Fungal infection

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

Time frame
5 years
4

Viral infection

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

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

The First Hospital of Jilin University

Collaborator

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

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: