T-cell Developmental Status in Patients With Malignant Hematological Tumors

Last updated: July 19, 2025
Sponsor: The First Affiliated Hospital of Xiamen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Cancer

Hematologic Neoplasms

Treatment

observational study

Clinical Study ID

NCT07035938
XMDYYYXYK-0616
  • Ages > 18
  • All Genders

Study Summary

To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies.

Eligibility Criteria

Inclusion

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 byhistopathology, bone marrow pathology, flow cytometry, morphology, and genetictesting; Cohort 2: Patients with newly diagnosed or relapsed multiple myelomaconfirmed by the same methods; Cohort 3: Healthy volunteers;

  3. Able to understand and voluntarily sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Significant pulmonary disease: Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1second (FEV1) <50% of predicted normal value. Note: Suspected COPD cases requireFEV1 testing; subjects with FEV1 <50% of predicted must be excluded. Moderate/severe persistent asthma within the past 2 years, or currently uncontrolledasthma of any severity. (Note: Controlled intermittent or mild persistent asthma ispermitted.)

  2. Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic/uncontrolledarrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) >500 ms (Fridericia formula) at screening.

  3. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-relatedpneumonitis, 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 bloodpositivity, ulcerative colitis, or other conditions at risk of gastrointestinalbleeding/perforation (as determined by the investigator).

  6. Severe neurological/psychiatric disorders, immunodeficiency, hepatitis/cirrhosis, orother conditions deemed unsuitable for study participation by the investigator.

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: observational study
Phase:
Study Start date:
June 22, 2025
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Zhijuan Lin

    Xiamen, Fujian 361000
    China

    Active - Recruiting

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