Hematologic MalignancyNCT07035938
T-cell Developmental Status in Patients With Malignant Hematological Tumors
An observational study of Hematologic Malignancy, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- observational study
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2025to 30 Jun 2028
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Cohort 1: 25 patients with newly diagnosed or relapsed B-cell lymphoma; Cohort 2: 25 patients with newly diagnosed or relapsed multiple myeloma; Cohort 3: 25 healthy controls.
Who may be able to join
- Age ≥ 18 years; both genders included; expected survival > 3 months;
- Cohort 1: Patients with newly diagnosed or relapsed B-cell lymphoma confirmed by histopathology, bone marrow pathology, flow cytometry, morphology, and genetic testing; Cohort 2: Patients with newly diagnosed or relapsed multiple myeloma confirmed by the same methods; Cohort 3: Healthy volunteers;
- Able to understand and voluntarily sign the informed consent form.
Who cannot join
- Significant pulmonary disease:
- Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <50% of predicted normal value. Note: Suspected COPD cases require FEV1 testing; subjects with FEV1 <50% of predicted must be excluded.
- Moderate/severe persistent asthma within the past 2 years, or currently uncontrolled asthma of any severity. (Note: Controlled intermittent or mild persistent asthma is permitted.)
- Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic/uncontrolled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) >500 ms (Fridericia formula) at screening.
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function.
- HIV infection (positive HIV-1/2 antibodies) or known syphilis infection.
- Unhealed wounds, fractures, gastroduodenal ulcers, persistent fecal occult blood positivity, ulcerative colitis, or other conditions at risk of gastrointestinal bleeding/perforation (as determined by the investigator).
- Severe neurological/psychiatric disorders, immunodeficiency, hepatitis/cirrhosis, or other conditions deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhijuan Lin
Xiamen, Fujian, 361000
Zhijuan Lin, Dr, 15960283462, zjuan_lin@126.com
Zhijuan Lin, 15960283462, zjuan_lin@126.com
About this study
Official title: An Observational, Bidirectional Cohort Study to Evaluate T-cell Developmental Status in Patients With Malignant Hematological Tumors
To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies.
Read the detailed description
Primary Objective:
To evaluate the immune status and prognosis of patients with newly diagnosed or relapsed B-cell lymphoma and multiple myeloma by dynamically monitoring peripheral blood thymus seeding progenitors (TSP), recent thymic emigrants (RTE), T-cell receptor rearrangement excision circles (TREC), naive T-cells, and developmental/functional T-cell subsets before and after treatment, thereby guiding clinical therapeutic strategies.
Secondary Objective:
To monitor remission rates, survival outcomes, and infection rates in patients with hematological malignancies, and to explore their association with dynamic changes in developmental/functional T-cell subsets.
- Conditions
- Hematologic Malignancy
- Being tested
- observational study
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| B-cell lymphoma | Patients with newly diagnosed or relapsed B-cell lymphoma Receives: Other: observational study | |
| Multiple myeloma | Patients with newly diagnosed or relapsed multiple myeloma Receives: Other: observational study | |
| HC | Healthy controls Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of TSP/RTE, TREC, and mature T-cell subsets，%
Dynamic changes in peripheral blood TSP/RTE, TREC, and mature T-cell subsets before treatment initiation, before the 2nd, 3rd, and 5th treatment cycles
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start22 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijuan Lin, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035938
- Sponsor's protocol ID
- XMDYYYXYK-0616
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Bidirectional Cohort Study to Evaluate T-cell Developmental Status in Patients With Malignant Hematological Tumors
- ClinicalTrials.gov ID
- NCT07035938
- Acronym / sponsor ID
- XMDYYYXYK-0616
- Conditions
- Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jun 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.
To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies.
Detailed description
Primary Objective:
To evaluate the immune status and prognosis of patients with newly diagnosed or relapsed B-cell lymphoma and multiple myeloma by dynamically monitoring peripheral blood thymus seeding progenitors (TSP), recent thymic emigrants (RTE), T-cell receptor rearrangement excision circles (TREC), naive T-cells, and developmental/functional T-cell subsets before and after treatment, thereby guiding clinical therapeutic strategies.
Secondary Objective:
To monitor remission rates, survival outcomes, and infection rates in patients with hematological malignancies, and to explore their association with dynamic changes in developmental/functional T-cell subsets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-cell lymphoma | – | Other: observational studyPatients with newly diagnosed or relapsed B-cell lymphoma |
| Multiple myeloma | – | Other: observational studyPatients with newly diagnosed or relapsed multiple myeloma |
| HC | – | Other: observational studyHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: 25 patients with newly diagnosed or relapsed B-cell lymphoma; Cohort 2: 25 patients with newly diagnosed or relapsed multiple myeloma; Cohort 3: 25 healthy controls.
Key inclusion criteria (3 listed)
- Age ≥ 18 years; both genders included; expected survival > 3 months;
- Cohort 1: Patients with newly diagnosed or relapsed B-cell lymphoma confirmed by histopathology, bone marrow pathology, flow cytometry, morphology, and genetic testing; Cohort 2: Patients with newly diagnosed or relapsed multiple myeloma confirmed by the same methods; Cohort 3: Healthy volunteers;
- Able to understand and voluntarily sign the informed consent form.
Key exclusion criteria (8 listed)
- Significant pulmonary disease:
- Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <50% of predicted normal value. Note: Suspected COPD cases require FEV1 testing; subjects with FEV1 <50% of predicted must be excluded.
- Moderate/severe persistent asthma within the past 2 years, or currently uncontrolled asthma of any severity. (Note: Controlled intermittent or mild persistent asthma is permitted.)
- Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic/uncontrolled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) >500 ms (Fridericia formula) at screening.
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function.
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 |
|---|---|---|
| observational studyobservational study | Other | B-cell lymphoma, HC, Multiple myeloma |
Primary outcome
Percentages of TSP/RTE, TREC, and mature T-cell subsets，%
Time frame: Up to 36 months
Dynamic changes in peripheral blood TSP/RTE, TREC, and mature T-cell subsets before treatment initiation, before the 2nd, 3rd, and 5th treatment cycles
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 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of TSP/RTE, TREC, and mature T-cell subsets，% (time frame: Up to 36 months). 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 23 Jul 2025.