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Recruiting Phase 2 / Phase 3

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

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About this study

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

Condition
Diffuse Large B-Cell Lymphoma (DLBCL)
Tested
Xinlikang capsules, mimic capsules
Sponsor
Sun Yat-sen University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Study condition: Diffuse Large B-Cell Lymphoma (DLBCL)
  • 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).

Exclusion 10

  • 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

1 site, 1 recruiting

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.