PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
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 an
| Condition(s) | Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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: Here is the translated text: 1. Subjects who have previously used any PI3K inhibitors; 2. Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug; 3. Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period; 4. Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia); 5. HBV or HCV infection (defined as HBsAg and/ |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Locations | Tianjin, Tianjin Municipality, China |
| Start date | 2024-08-10 |
| NCT ID | NCT06530550 |
| Official listing | https://clinicaltrials.gov/study/NCT06530550 |