Indolent B-cell LymphomaPhase 4NCT06343935
A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma
A Phase 4 study testing Linperlisib in people with Indolent B-cell Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent B-cell Lymphoma
- What is being tested?
- Linperlisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients with r/r indolent B-cell lymphoma confirmed by histology or cytology, mainly follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma (MZL), and lymphoplasmacytic lymphoma/macroglobulinemia (LPL/WM),
- ECOG performance status (PS) 0 ~ 2 points,
- Expected survival ≥3 months,
- 5) At least one measurable lesion was present in patients other than CLL, LPL/WM; 6) Good organ function level, 7) The elution period from the end of previous anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, surgery or molecular targeted therapy) to participation in this trial is ≥4 weeks, in which the elution period of small-molecule targeted drugs and Chinese medicines with anti-tumor effects is ≥14 days.
Who cannot join
- Those who have progressed with antitumor drugs targeting PI3Kδ (except for those who cannot tolerate them),
- There is a third space effusion (such as a large amount of pleural fluid and ascites) that the investigators judge to be uncontrollable,
- Steroid hormone dosage (equivalent amount of prednisone) was greater than 20mg/ day for 4 weeks before enrollment, and continuous use was more than 14 days,
- Inability to swallow, chronic diarrhea or intestinal obstruction, there are multiple factors that affect drug use and absorption,
- Allergic constitution, or known allergic history of the drug components,
- Patients with active viral, bacterial or fungal infections (such as pneumonia) within 4 weeks prior to enrollment; Or had uncontrolled pulmonary fibrosis, acute lung disease, or interstitial lung disease within 4 weeks prior to enrollment,
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- Infected with HBV and HCV,
- History of immune deficiency,
- Moderate or severe heart disease,
- Have undergone major surgery within 28 days before signing informed consent, or plan to undergo major surgery during the study period,
- The first study of patients with a history of other malignancies within 5 years prior to drug administration (except for patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ without disease recurrence within 2 years),
- Received autologous hematopoietic stem cell transplantation within 90 days before the first medication,
Trial locations and contacts
No sites are listed yet.
About this study
This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode).
Read the detailed description
This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode).
Patients were divided to two groups by stratified randomization according to tumor type (FL, CLL/SLL, MZL, others) during the screening period. Both groups were orally administered with a starting dose of 80mg qd for 21 days. On the 21st day of the 4th cycle, if the patient's tumor does not progress and there is no intolerable toxicity, after the researchers determined that medication could be continued, one group of patients continued to take 80mg qd dose continuously, and the other group of patients continued to take 80mg qd dose continuously for two weeks per cycle and stopped for one week, and safety and tumor efficacy evaluation were conducted regularly. The maximum duration of treatment is two years until the disease progresses, toxicity becomes intolerable, or the investigator determines that it is not appropriate to continue treatment.
- Conditions
- Indolent B-cell Lymphoma
- Being tested
- Linperlisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinperlisibDrug
Also called YY-20394
Linperlisib is a small molecule inhibitor of phosphoinositol 3-kinase-δ (PI3K-δ)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group(linperlisib 80mg qd) | Experimental | After enrollment, the patients in treatment group were orally administered with a starting dose of 80mg qd for 21 days. On the 21st day of the 4th cycle, if the patient has no tumor progression and no intolerable toxicity, after the researcher determines that the drug therapy can be continued, the patient should take linperlisib 80mg qd for two consecutive weeks per cycle and stop taking it for one week, and conduct regular safety and tumor efficacy evaluation until the disease progresses, toxicity becomes intolerable or the researcher determines that it is not suitable to continue treatment. The maximum duration of treatment is two years. Receives: Drug: Linperlisib |
| control group(linperlisib 80mg 14d-on 7d-off) | Experimental | In the control group, patients were orally administered at the starting dose of 80mg qd for 21 days after enrollment. On the 21st day of the 4th cycle, if the patient has no tumor progression and no intolerable toxicity, the patient will continue to receive Linperlisib 80mg qd after the investigator determines that the drug therapy can be continued, and the safety and tumor efficacy evaluation will be conducted regularly until the disease progresses, toxicity becomes intolerable, or the investigator determines that the treatment is not suitable for further treatment. The maximum duration of treatment is two years. Receives: Drug: Linperlisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
The time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.
Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months
Secondary outcomes (4)
Objective response rate
The proportion of subjects who have a Complete Response or Partial Response
Measured: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months
Overall survival
The time from the first dose of study treatment to death for any reason.
Measured: From the first dose to the date of death from any cause, whichever comes first，up to 24months
Adverse event
Incidence of adverse events evaluated by NCI CTCAE v5.0 and associated dose of linperlisib
Measured: From enrollment receiving Linperlisib to 30 days after the last linperlisib treatment.
Serious adverse event
Incidence of serious adverse event and associated dose of linperlisib
Measured: From enrollment receiving Linperlisib to 30 days after the last linperlisib treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent B-cell LymphomaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Ma, Principal investigator, Hematology Tumor Research Center of Harbin First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343935
- Sponsor's protocol ID
- YY-20394-014
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma
- ClinicalTrials.gov ID
- NCT06343935
- Acronym / sponsor ID
- YY-20394-014
- Conditions
- Indolent B-cell Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 3 Apr 2024 (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.
This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode).
Detailed description
This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode).
Patients were divided to two groups by stratified randomization according to tumor type (FL, CLL/SLL, MZL, others) during the screening period. Both groups were orally administered with a starting dose of 80mg qd for 21 days. On the 21st day of the 4th cycle, if the patient's tumor does not progress and there is no intolerable toxicity, after the researchers determined that medication could be continued, one group of patients continued to take 80mg qd dose continuously, and the other group of patients continued to take 80mg qd dose continuously for two weeks per cycle and stopped for one week, and safety and tumor efficacy evaluation were conducted regularly. The maximum duration of treatment is two years until the disease progresses, toxicity becomes intolerable, or the investigator determines that it is not appropriate to continue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group(linperlisib 80mg qd) | Experimental | Drug: LinperlisibAfter enrollment, the patients in treatment group were orally administered with a starting dose of 80mg qd for 21 days. On the 21st day of the 4th cycle, if the patient has no tumor progression and no intolerable toxicity, after the researcher determines that the drug therapy can be continued, the patient should take linperlisib 80mg qd for two consecutive weeks per cycle and stop taking it for one week, and conduct regular safety and tumor efficacy evaluation until the disease progresses, toxicity becomes intolerable or the researcher determines that it is not suitable to continue treatment. The maximum duration of treatment is two years. |
| control group(linperlisib 80mg 14d-on 7d-off) | Experimental | Drug: LinperlisibIn the control group, patients were orally administered at the starting dose of 80mg qd for 21 days after enrollment. On the 21st day of the 4th cycle, if the patient has no tumor progression and no intolerable toxicity, the patient will continue to receive Linperlisib 80mg qd after the investigator determines that the drug therapy can be continued, and the safety and tumor efficacy evaluation will be conducted regularly until the disease progresses, toxicity becomes intolerable, or the investigator determines that the treatment is not suitable for further treatment. The maximum duration of treatment is two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with r/r indolent B-cell lymphoma confirmed by histology or cytology, mainly follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma (MZL), and lymphoplasmacytic lymphoma/macroglobulinemia (LPL/WM),
- ECOG performance status (PS) 0 ~ 2 points,
- Expected survival ≥3 months,
- 5) At least one measurable lesion was present in patients other than CLL, LPL/WM; 6) Good organ function level, 7) The elution period from the end of previous anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, surgery or molecular targeted therapy) to participation in this trial is ≥4 weeks, in which the elution period of small-molecule targeted drugs and Chinese medicines with anti-tumor effects is ≥14 days.
Key exclusion criteria (12 listed)
- Those who have progressed with antitumor drugs targeting PI3Kδ (except for those who cannot tolerate them),
- There is a third space effusion (such as a large amount of pleural fluid and ascites) that the investigators judge to be uncontrollable,
- Steroid hormone dosage (equivalent amount of prednisone) was greater than 20mg/ day for 4 weeks before enrollment, and continuous use was more than 14 days,
- Inability to swallow, chronic diarrhea or intestinal obstruction, there are multiple factors that affect drug use and absorption,
- Allergic constitution, or known allergic history of the drug components,
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 |
|---|---|---|
| LinperlisibAlso: YY-20394Linperlisib is a small molecule inhibitor of phosphoinositol 3-kinase-δ (PI3K-δ) | Drug | Treatment group(linperlisib 80mg qd), control group(linperlisib 80mg 14d-on 7d-off) |
Primary outcome
Progression free survival
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months
The time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.
4 secondary outcomes
Objective response rate
Time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months
Overall survival
Time frame: From the first dose to the date of death from any cause, whichever comes first，up to 24months
Adverse event
Time frame: From enrollment receiving Linperlisib to 30 days after the last linperlisib treatment.
Serious adverse event
Time frame: From enrollment receiving Linperlisib to 30 days after the last linperlisib treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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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. This study is not recruiting at the moment.
Jun Ma principal investigator
Hematology Tumor Research Center of Harbin First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linperlisib in people with Indolent B-cell Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd..
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Ma (0451-84883471, majun0322@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months). 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 3 Apr 2024.