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โ† Trials
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PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

RecruitingPhase 2Ages 18 Years - anyAllInstitute of Hematology & Blood Diseases Hospitalโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • PI3K inhibitor
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Where

1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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