T-cell Developmental Status in Patients With Malignant Hematological Tumors

NCT07035938 | Recruiting

• 1 other identifier: XMDYYYXYK-0616
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Percentages of TSP/RTE, TREC, and mature T-cell subsets，%

  Dynamic changes in peripheral blood TSP/RTE, TREC, and mature T-cell subsets before treatment initiation, before the 2nd, 3rd, and 5th treatment cycles

  Up to 36 months

Study Arms (3)

B-cell lymphoma

Patients with newly diagnosed or relapsed B-cell lymphoma

Other: observational study

Multiple myeloma

Patients with newly diagnosed or relapsed multiple myeloma

Other: observational study

HC

Healthy controls

Other: observational study

Interventions

observational study OTHER

observational study

B-cell lymphoma; HC; Multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1: 25 patients with newly diagnosed or relapsed B-cell lymphoma; Cohort 2: 25 patients with newly diagnosed or relapsed multiple myeloma; Cohort 3: 25 healthy controls.

You may qualify if:

• Age ≥ 18 years; both genders included; expected survival \> 3 months;
• 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;
• Able to understand and voluntarily sign the informed consent form.

You may not qualify if:

• 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.)
• 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.
• History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function.
• HIV infection (positive HIV-1/2 antibodies) or known syphilis infection.
• 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).
• Severe neurological/psychiatric disorders, immunodeficiency, hepatitis/cirrhosis, or other conditions deemed unsuitable for study participation by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Zhijuan Lin

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: June 22, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)