T-cell Developmental Status in Patients With Malignant Hematological Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational, Bidirectional Cohort Study to Evaluate T-cell Developmental Status in Patients With Malignant Hematological Tumors
Overview
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.
Interventions
- Other observational study
observational study
Primary outcome measures
- Percentages of TSP/RTE, TREC, and mature T-cell subsets，% [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhijuan Lin — Xiamen
Identifiers
NCT: NCT07035938 · XMDYYYXYK-0616