T-cell developmental status in people with blood cancers
An Observational, Bidirectional Cohort Study to Evaluate T-cell Developmental Status in Patients With Malignant Hematological Tumors
This project will see if tracking T-cell development and immune markers before and after treatment can help guide care for adults with B-cell lymphoma or multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT07035938 on ClinicalTrials.gov |
What this trial studies
This observational protocol will follow adults with newly diagnosed or relapsed B-cell lymphoma or multiple myeloma and include healthy volunteers, collecting peripheral blood at baseline and after treatment. Lab tests will measure thymus-seeding progenitors (TSP), recent thymic emigrants (RTE), T-cell receptor excision circles (TREC), naive T cells, and other developmental and functional T-cell subsets. These immune measures will be correlated over time with remission status, survival, and infection rates. The aim is to identify immune patterns that predict prognosis and could inform clinical therapeutic decisions.
Who should consider this trial
Good fit: Adults aged 18 or older with newly diagnosed or relapsed B-cell lymphoma or multiple myeloma, or healthy volunteers, who can give informed consent and have expected survival greater than three months.
Not a fit: Patients with significant pulmonary disease (e.g., COPD with FEV1 <50% or uncontrolled moderate/severe asthma) or symptomatic congestive heart failure (NYHA class II–IV) are excluded and therefore are unlikely to participate or benefit from this protocol's findings.
Why it matters
Potential benefit: If successful, this could help doctors tailor treatments and predict who is more likely to relapse or develop infections by identifying T-cell changes linked to better or worse outcomes.
How similar studies have performed: Prior research shows TREC, RTE, and naive T-cell counts can reflect thymic output and predict immune recovery in hematologic cancers, but prospectively combining these dynamic markers across B-cell lymphoma and myeloma to guide therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xiamen, Fujian
- Zhijuan Lin — Xiamen, Fujian, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.