Status:
RECRUITING
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Lymphoma, T-Cell
NK-LGL Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Here is the translated text:
- Subjects who have previously used any PI3K inhibitors;
- Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
- Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- 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;
- 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;
- Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
- Presence of severe or uncontrolled cardiovascular disease;
- 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);
- Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
- Diagnosed or treated for other malignancies within the past 5 years;
- Any other condition that the investigator deems unsuitable for participation in the study.
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2028
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06530550
Start Date
August 10 2024
End Date
July 10 2028
Last Update
August 12 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020