Clinical trial · Interventional
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas:An Open, Prospective, Exploratory Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| NK-LGL Leukemia | Chronic Lymphoproliferative Disorder of NK-Cells | ALIAS | 0.90 |
| T-LGL Leukemia | T-Cell Large Granular Lymphocyte Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PI3K inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PI3K inhibitor
- description
- Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally
- interventionNames
- Drug: PI3K inhibitor
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- up to 5 years
- description
- complete remission rate+ partial remission rate
Secondary outcomes (7)
- measure
- The safety of PI3K inhibitors
- timeFrame
- up to 5 years
- description
- Incidence of adverse events, serious adverse events and significant adverse event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive; 6. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation; 7. Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment; 8. Presence of severe or uncontrolled cardiovascular disease; 9. Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease); 10. Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential; 11. Diagnosed or treated for other malignancies within the past 5 years; 12. Any other condition that the investigator deems unsuitable for participation in the study.
References
Publications (0)
Data not yet available