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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib | Drug | Linperlisib is a small molecule inhibitor of phosphoinositol 3-kinase-δ (PI3K-δ) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose to the date of disease progression or date of death from any cause, whichever comes first,up to 24months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of subjects who have a Complete Response or Partial Response | 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 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | 0451-84883471 | majun0322@126.com | |
| Donglu Zhao | Contact | 0451-84883471 | zdl7777@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Ma | Hematology Tumor Research Center of Harbin First Hospital | Principal Investigator |
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The time from the first dose of study treatment to death for any reason.
| 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 | 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 | From enrollment receiving Linperlisib to 30 days after the last linperlisib treatment. |