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

Inclusion Criteria:

1. Age ≥18 years old;

2. Newly diagnosed diffuse large B lymphoma (DLBCL);

3. Patients had completed the first-line treatment of chemotherapy and immunotherapyand the course of treatment had been completed.

4. Metabolic complete response (CR) was evaluated by PET/CT during or afterchemotherapy.

5. Had completed the full course of chemotherapy-containing regimen for more than 30-90days;

6. BFI fatigue score ≥4;

7. The expected survival time was ≥6 months;

8. No treatment plan for CD20 monoclonal antibody, radiotherapy, chemotherapy,lenalidomide, thymopeptides, targeted drugs, biological agents, immunosuppressiveagents, other Chinese medicine decoction or Chinese patent medicine in the next 3months;

9. No grade 3-4 surgery plan is expected in the next 3 months;

10. They had normal mental consciousness, could understand the content of thequestionnaire correctly, and could complete the questionnaire with assistance orindependently;

11. Women and men of childbearing age agreed to use contraception during and for 1 monthafter treatment;

12. They volunteered to participate in the clinical trial and signed the informedconsent form, which was in accordance with the requirements of Good ClinicalPractice (GCP).

Exclusion Criteria:

1. DLBCL subjects with CNS involvement at initial diagnosis;

2. Allergic or intolerant to Xinlikang capsule or its component drugs;

3. Significant abnormal liver and kidney function: ALT, AST, GGT≥3 ULN; BUN and Cr≥3ULN;

4. 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;

5. Patients with HIV virus infection, bacterial infection and other immune-relateddiseases that affect immune function as judged by clinicians;

6. Uncontrolled HBV or HCV infection: Hepatitis B Virus (HBV) DNA testing exceeding thelower limit of detection or 1000 copies /mL or 500 IU/mL (the higher is thereference) during screening in patients with a history of chronic hepatitis B; HCVRNA detection in patients with a history of Hepatitis C Virus (HCV) infection duringthe 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).

7. Patients with other malignancies.

8. Enrollment in another clinical trial 30 days before screening or during the trial;

9. Persons who were deemed by the investigator to be ineligible to participate in thetrial.