Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2/3NCT07084662
Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma
A Phase 2/3 study testing Xinlikang capsules and mimic capsules in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Sun Yat-sen University at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Xinlikang capsules and mimic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2025to 1 Aug 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
Qingqing Cai, +862087342823, caiqq@sysucc.org.cn
caiqq@sysucc.org.cn
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Xinlikang Capsule in the Treatment of Chemotherapy-induced Fatigue and Immune Disorders in Patients With Diffuse Large B Lymphoma
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
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Xinlikang capsules, mimic capsules
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xinlikang capsulesDrug
Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks
mimic capsulesDrug
mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Xinlikang capsules | Experimental | The experimental group was treated with Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks. Receives: Drug: Xinlikang capsules |
| Mimic capsules | Placebo comparator | The control group was treated with mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks. Receives: Drug: mimic capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of FACIT Fatigue Scale score
The scale ranges from 0 to 4, with lower scores indicating better outcomes.
Measured: From baseline to 12 weeks of treatment
Secondary outcomes (3)
The difference of FACIT Fatigue Scale scores
The scale ranges from 0 to 4, with lower scores indicating better outcomes.
Measured: Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment.
BFI
The scale ranges from 0 to 10, with lower scores indicating better outcomes.
Measured: BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment
FACT-Lym total score
The scale ranges from 0 to 4, with lower scores indicating better outcomes.
Measured: FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start11 Sep 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084662
- Sponsor's protocol ID
- B2025-004
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Xinlikang Capsule in the Treatment of Chemotherapy-induced Fatigue and Immune Disorders in Patients With Diffuse Large B Lymphoma
- ClinicalTrials.gov ID
- NCT07084662
- Acronym / sponsor ID
- B2025-004
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xinlikang capsules | Experimental | Drug: Xinlikang capsulesThe experimental group was treated with Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks. |
| Mimic capsules | Placebo comparator | Drug: mimic capsulesThe control group was treated with mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xinlikang capsulesXinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks | Drug | Xinlikang capsules |
| mimic capsulesmimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks. | Drug | Mimic capsules |
Primary outcome
The difference of FACIT Fatigue Scale score
Time frame: From baseline to 12 weeks of treatment
The scale ranges from 0 to 4, with lower scores indicating better outcomes.
3 secondary outcomes
The difference of FACIT Fatigue Scale scores
Time frame: Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment.
BFI
Time frame: BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment
FACT-Lym total score
Time frame: FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xinlikang capsules and mimic capsules in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of FACIT Fatigue Scale score (time frame: From baseline to 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.