Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia
Conditions
Keywords
Indolent T/NK-cell lymphomas, PI3K inhibitor
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
Interventions
DRUGPI3K inhibitor
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
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | up to 5 years | complete remission rate+ partial remission rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of remission | up to 5 years | the time from response to progression/death (P/D) |
| Time to response | up to 5 years | from the start of treatment to the first observed partial remission |
| The safety of PI3K inhibitors | up to 5 years | Incidence of adverse events, serious adverse events and significant adverse event |
| 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). |
| Progression-free survival | up to 5 years | the time from treatment initiation until disease progression or death |
Countries
China
Contacts
Primary ContactShuhua Yi, Doctor
Backup ContactLugui Qiu, Doctor
Outcome results
None listed