Using PI3K inhibitors to treat relapsed 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

This study is testing if two new oral medications can help people with relapsed indolent T/NK-cell lymphomas feel better and improve their treatment options.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06530550 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of PI3K inhibitors, specifically Linperlisib and Duvelisib, in patients with relapsed or refractory indolent T/NK-cell lymphomas. The study plans to enroll 51 patients who will receive the treatment orally over a series of cycles, with efficacy assessed regularly. The goal is to determine the overall response rate and the feasibility of this treatment option for a group of lymphoproliferative diseases that currently have limited effective therapies.

Who should consider this trial

Good fit: Ideal candidates are patients with relapsed or refractory indolent T/NK-cell lymphomas who have not previously received PI3K inhibitors.

Not a fit: Patients with active infections, certain gastrointestinal conditions, or those who have previously used PI3K inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with few alternatives for managing their lymphoma.

How similar studies have performed: While the use of PI3K inhibitors in other types of lymphomas has shown promise, this specific application in indolent T/NK-cell lymphomas is relatively novel.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Shuhua Yi, Doctor — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Shuhua Yi, Doctor

Conditions: Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia, Indolent T/NK-cell lymphomas, PI3K inhibitor