PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Phase 2

Recruiting

• Conditions: T-LGL Leukemia; Lymphoma, T-Cell; NK-LGL Leukemia
• Interventions: Drug: PI3K inhibitor

• Registration Number: NCT06530550
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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 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.

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 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

Study Timeline

• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Study First Posted: 2024-07-31
• Status Verified: 2024-08
• Study Start: 2024-08-10
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-07-10
• Study Completion: 2028-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PI3K inhibitor	PI3K inhibitor	Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 5 years	complete remission rate+ partial remission rate

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 5 years	The time from the start of treatment to the patient's death from any cause
Disease control rate	up to 5 years	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).
Duration of remission	up to 5 years	the time from response to progression/death (P/D)
Complete remession rate	up to 5 years	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
Progression-free survival	up to 5 years	the time from treatment initiation until disease progression or death
The safety of PI3K inhibitors	up to 5 years	Incidence of adverse events, serious adverse events and significant adverse event
Time to response	up to 5 years	from the start of treatment to the first observed partial remission

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China