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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 28, 2024

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ClinConnect Summary

This clinical trial is studying the use of new medications called PI3K inhibitors to treat patients with indolent T/NK-cell lymphomas that have not responded to earlier treatments. These types of lymphomas grow slowly and are currently difficult to cure, leaving many patients with limited options. In this study, patients will receive one of two specific drugs, Linperlisib or Duvelisib, to see how effective and safe these treatments are. The researchers hope that about 60% of participants will respond positively to the treatment, meaning their cancer may shrink or stabilize.

To participate, patients should be between the ages of 65 and 74 and must meet certain health criteria. For example, they should not have used PI3K inhibitors before or have certain serious health conditions that could interfere with the study. Participants can expect to receive close monitoring throughout the trial to assess how well the treatment works and to ensure their safety. It's important to know that this study is currently recruiting participants, and if you or a loved one is interested, discussing it with a healthcare provider can provide more personalized information.

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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.