Chronic Myelomonocytic Leukemia (CMML)NCT07113730
The Kinetics Profiling of Immune Reconstitution and Clinical Outcomes
An observational study of Chronic Myelomonocytic Leukemia (CMML) and Immune Reconstitution, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Myelomonocytic Leukemia (CMML), Immune Reconstitution
- What is being tested?
- immune reconstitution
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2025to 31 Jul 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with confirmed diagnosis of CMML following HSCT
- Patients treated at Peking University People's Hospital since January 1, 2005
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective and Prospective Study on the Kinetics Profiling of Immune Reconstitution and Clinical Outcomes in CMML Following Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Being tested
- immune reconstitution
- Keywords
- Chronic Myelomonocytic Leukemia (CMML), immune reconstitution, allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immune reconstitutionOther
Detection of immune reconstitution in peripheral blood of patients by flow cytometry at 30-day intervals for 180 days post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: immune reconstitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Immunoglobulin levels
To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL).
Measured: 180 days
2-year OS
To describe the incidence of 2-year OS
Measured: 2 years
5-year PFS
To describe the incidence of 5-year PFS
Measured: 5 years
Secondary outcomes (5)
cGVHD
To describe the number of patients diagnosed with chronic graft-versus-host disease (cGVHD)
Measured: 5 years
Bacterial infection
To describe the number of patients with bacterial infection detected in blood, stool, sputum, etc. after HSCT
Measured: 5 years
Fungal infection
To describe the number of patients with fungal infection detected in blood, stool, sputum, etc. after HSCT
Measured: 5 years
Viral infection
To describe the number of patients with viral infection detected in blood, stool, sputum, etc. after HSCT
Measured: 5 years
aGVHD
To describe the number of patients diagnosed with acute graft-versus-host disease (aGVHD)
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start13 Aug 2025 (estimated)
- Primary completion31 Jul 2035 (estimated)
- Study completion31 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic Leukemia (CMML)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, MD, Principal investigator, Peking University Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113730
- Sponsor's protocol ID
- 2025PHB073-001
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Study on the Kinetics Profiling of Immune Reconstitution and Clinical Outcomes in CMML Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07113730
- Acronym / sponsor ID
- 2025PHB073-001
- Keywords
- Chronic Myelomonocytic Leukemia (CMML), immune reconstitution, allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 13 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2035 (estimated)
- Study completion
- 31 Jul 2036 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: immune reconstitutionPatients 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. |
| Prospective cohort | – | Other: immune reconstitutionPatients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. |
| Retrospective/Prospective cohort | – | Other: immune reconstitutionPatients 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of CMML following HSCT
- Patients treated at Peking University People's Hospital since January 1, 2005
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immune reconstitutionDetection of immune reconstitution in peripheral blood of patients by flow cytometry at 30-day intervals for 180 days post-transplantation. | Other | Prospective cohort, Retrospective cohort, Retrospective/Prospective cohort |
Primary outcome
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.
Immunoglobulin levels
Time frame: 180 days
To test for serum immunoglobulin (IgG, IgA, IgM) (mg/dL).
2-year OS
Time frame: 2 years
To describe the incidence of 2-year OS
5-year PFS
Time frame: 5 years
To describe the incidence of 5-year PFS
5 secondary outcomes
cGVHD
Time frame: 5 years
Bacterial infection
Time frame: 5 years
Fungal infection
Time frame: 5 years
Viral infection
Time frame: 5 years
aGVHD
Time frame: 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao-Hui Zhang, MD principal investigator
Peking University Institute of Hematology, Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelomonocytic Leukemia (CMML) and Immune Reconstitution, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengtong Zang, MD (18744579871, zangztong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune reconstitution (time frame: 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.