Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma

Recruiting now · Phase 2/Phase 3

Conditions studied: Diffuse Large B-Cell Lymphoma (DLBCL)

In brief

To evaluate the efficacy and safety of Xinlikang capsule in the treatment of cancer-related fatigue (CRF) and peripheral blood lymphocytes in patients with diffuse large B-cell lymphoma (DLBCL) who achieved complete remission (CR) after all courses of chemotherapy-containing regimens

Key facts

Study ID

NCT07084662

Run by

Sun Yat-sen University

People needed

80

Starts

2025-09-11

Expected to finish

2030-08-01

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years old;
• Newly diagnosed diffuse large B lymphoma (DLBCL);
• Patients had completed the first-line treatment of chemotherapy and immunotherapy and the course of treatment had been completed.
• Metabolic complete response (CR) was evaluated by PET/CT during or after chemotherapy.
• Had completed the full course of chemotherapy-containing regimen for more than 30-90 days;
• BFI fatigue score ≥4;
• The expected survival time was ≥6 months;
• No treatment plan for CD20 monoclonal antibody, radiotherapy, chemotherapy, lenalidomide, thymopeptides, targeted drugs, biological agents, immunosuppressive agents, other Chinese medicine decoction or Chinese patent medicine in the next 3 months;
• No grade 3-4 surgery plan is expected in the next 3 months;
• They had normal mental consciousness, could understand the content of the questionnaire correctly, and could complete the questionnaire with assistance or independently;
• Women and men of childbearing age agreed to use contraception during and for 1 month after treatment;
• They volunteered to participate in the clinical trial and signed the informed consent form, which was in accordance with the requirements of Good Clinical Practice (GCP).

You may not qualify if…

• DLBCL subjects with CNS involvement at initial diagnosis;
• Allergic or intolerant to Xinlikang capsule or its component drugs;
• Significant abnormal liver and kidney function: ALT, AST, GGT≥3 ULN; BUN and Cr≥3 ULN;
• Severe abnormal bone marrow function: white blood cell ≤1.0×10\^9/L, neutrophil ≤0.5×10\^9/L, platelet ≤30×10\^9/L, hemoglobin ≤6g/dL;
• Patients with HIV virus infection, bacterial infection and other immune-related diseases that affect immune function as judged by clinicians;
• Uncontrolled HBV or HCV infection: Hepatitis B Virus (HBV) DNA testing exceeding the lower limit of detection or 1000 copies /mL or 500 IU/mL (the higher is the reference) during screening in patients with a history of chronic hepatitis B; HCV RNA detection in patients with a history of Hepatitis C Virus (HCV) infection during the screening period exceeded the detection limit of the assay or 1000 copies /mL or 500 IU/mL (whichever was higher was used as a reference).
• Patients with other malignancies.
• Enrollment in another clinical trial 30 days before screening or during the trial;
• Persons who were deemed by the investigator to be ineligible to participate in the trial.

Where it is running

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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