T-cell developmental status in people with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhijuan Lin
  Xiamen, Fujian, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.