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Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PI3K inhibitor | Experimental | Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PI3K inhibitor | Drug | Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | complete remission rate+ partial remission rate | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of PI3K inhibitors | Incidence of adverse events, serious adverse events and significant adverse event | up to 5 years |
| Complete remession rate | Hematological PR was defined as an improvement in blood counts ANC > 0.5 × 109/L; HGB increased by >1 g/dL; PLT > 50 × 109/L |
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Inclusion Criteria:
the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuhua Yi, Doctor | Contact | 86-22-23909106 | yishuhua@ihcams.ac.cn | |
| Lugui Qiu, Doctor | Contact | 86-22-23909172 | qiulg@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuhua Yi, Doctor | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| up to 5 years |
| Duration of remission | the time from response to progression/death (P/D) | up to 5 years |
| Time to response | from the start of treatment to the first observed partial remission | up to 5 years |
| Progression-free survival | the time from treatment initiation until disease progression or death | up to 5 years |
| Overall survival | The time from the start of treatment to the patient's death from any cause | up to 5 years |
| Disease control rate | the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD). | up to 5 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |