The First Affiliated Hospital of Xiamen University
Phase
Observational
Started
2025-06-22
Last updated
2025-07-23
Condition(s) studied
Hematologic Malignancy
Investigational drug(s) / intervention(s)
observational study
observational study: observational study
Study summary
To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years; both genders included; expected survival \> 3 months;
2. 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;
3. Able to understand and voluntarily sign the informed consent form.
Exclusion Criteria:
1. 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.)
2. 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.
3. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function.
4. HIV infection (positive HIV-1/2 antibodies) or known syphilis infection.
5. 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).
6. Severe neurological/psychiatric disorders, immunodeficiency, hepatitis/cirrhosis, or other conditions deemed unsuitable for study participation by the investigator.
Primary outcome measure(s)
Percentages of TSP/RTE, TREC, and mature T-cell subsets,% — 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
Trial sites (1)
Facility
City
Region
Status
Zhijuan Lin
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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