Xinlikang capsules for chemo-related fatigue and immune problems after DLBCL treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 interventional study enrolls adults with newly diagnosed diffuse large B-cell lymphoma who have achieved a metabolic complete response by PET/CT after completing first-line chemotherapy. Eligible participants with significant fatigue (BFI ≥4) and at least 30–90 days since finishing chemotherapy are assigned to receive Xinlikang capsules or matching mimic capsules. The study measures changes in cancer-related fatigue and peripheral blood lymphocyte counts, along with monitoring safety and adverse events. Outcomes will determine whether Xinlikang improves symptoms and immune parameters compared with the mimic capsules.

Why it matters

Who can join: the full rules

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 immunotherapy and the course of treatment had been completed.
4. Metabolic complete response (CR) was evaluated by PET/CT during or after chemotherapy.
5. Had completed the full course of chemotherapy-containing regimen for more than 30-90 days;
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, immunosuppressive agents, other Chinese medicine decoction or Chinese patent medicine in the next 3 months;
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 the questionnaire correctly, and could complete the questionnaire with assistance or independently;
11. Women and men of childbearing age agreed to use contraception during and for 1 month after treatment;
12. 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 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≥3 ULN;
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-related diseases that affect immune function as judged by clinicians;
6. 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).
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 the trial.

Where it's running

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai
• Email: caiqq@sysucc.org.cn
• Phone: 02087342823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.