Using PI3K inhibitors to treat relapsed indolent T/NK-cell lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yishuhua@ihcams.ac.cn
• Phone: 86-22-23909106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Golidocitnib treatment for relapsed indolent T/NK-cell lymphomas

  This study is testing if a new oral medication called Golidocitnib can help people with relapsed indolent T/NK-cell lymphomas feel better after other treatments haven't worked.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality and 1 other locations · NCT06716658

• National longitudinal cohort for large granular lymphocytic leukemia (LGLL)

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• Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.