NCT06530550 PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
| NCT ID | NCT06530550 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Lymphoma, T-Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-08-10 |
| Primary Completion | 2026-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2024-08-10 with a primary completion date of 2026-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Shuhua Yi, Doctor
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06530550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, T-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06530550 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06530550 currently recruiting?
Yes, NCT06530550 is actively recruiting participants. Contact the research team at yishuhua@ihcams.ac.cn for enrollment information.
Where is the NCT06530550 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06530550 clinical trial?
NCT06530550 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Shuhua Yi, Doctor at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 51 participants.