T-cell Developmental Status in Patients With Malignant Hematological Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observational study

    Other intervention

    observational study

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: B-cell lymphoma1 intervention
Group B: Multiple myeloma1 intervention
Group C: HC1 intervention

Trial outcomes

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

Time frame
Up to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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