T-cell Developmental Status in Patients With Malignant Hematological Tumors

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system, specifically certain immune cells called T-cells, behaves in people with blood cancers like lymphoma and multiple myeloma. The goal is to better understand patients’ immune health and outlook, which could help doctors choose the best treatments. The study is currently looking for adults aged 18 and older, including both men and women, who have recently been diagnosed with or experienced a return of these cancers. Healthy volunteers can also join as a comparison group.

If you take part, you’ll be asked to provide some medical information and samples so researchers can check your immune status. The study requires that participants are expected to live at least three months and do not have serious lung, heart, or certain other health problems. People with infections like HIV or syphilis, ongoing bleeding risks, or severe mental health issues would not be eligible. Before joining, you’ll receive clear information and be asked to give your voluntary consent. This study aims to help improve cancer care by learning more about how the immune system affects disease and treatment success.

Gender

ALL

Eligibility criteria

• 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.