ClinicalTrials.gov record NCT06530550
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This open-label Phase 2 trial gives oral PI3K inhibitors (Linperlisib or Duvelisib) to people with relapsed or refractory indolent T/NK‑cell lymphomas. Up to 51 patients will be treated in 28-day cycles for as long as 24 cycles unless disease progresses, there is no response within six cycles, or intolerable toxicity occurs. Response and safety will be checked regularly during treatment.
What it is studying. The study is testing whether oral PI3K inhibitors (Linperlisib or Duvelisib) produce tumor responses and what side effects they cause in people with relapsed or refractory indolent T/NK‑cell lymphomas. Key measurements include overall response rate, safety events, remission duration, time to response, progression-free survival, and overall survival.
What the researchers hope to learn. To evaluate the feasibility, effectiveness (measured mainly by overall response rate), and safety of Linperlisib or Duvelisib in relapsed/refractory indolent T/NK‑cell lymphomas. Secondary goals include measuring complete remission rate, duration of remission, time to response, progression-free survival, overall survival, and disease control rate.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- PI3K inhibitor
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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:
- Subjects who have previously used any PI3K inhibitors;
- Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
- Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- 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;
- 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;
- Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
- Presence of severe or uncontrolled cardiovascular disease;
- 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);
- Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
- Diagnosed or treated for other malignancies within the past 5 years;
- Any other condition that the investigator deems unsuitable for participation in the study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will take an oral PI3K inhibitor (Linperlisib 80 mg once daily or Duvelisib 25 mg twice daily) in 28‑day treatment cycles. They will have disease evaluations once per cycle during the first year and once every two cycles after that; treatment may continue for up to 24 cycles or stop earlier for disease progression, lack of response within the first 6 cycles, or intolerable toxicity. The study includes regular safety monitoring and assessments for response; women of childbearing potential will have baseline pregnancy testing. No unusually invasive procedures are specified in the registry record.
How the study is structured. An open-label, single-group Phase 2 treatment trial. Participants receive either Linperlisib 80 mg once daily or Duvelisib 25 mg twice daily by mouth in 28-day cycles. Efficacy is assessed every cycle during the first year and every two cycles afterward. Treatment continues up to 24 cycles or until progression, lack of response within six cycles, or intolerable toxicity.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Aug 10, 2024
- Primary completion
- Aug 10, 2026 (estimated)
- Study completion
- Jul 10, 2028 (estimated)
- Target enrollment
- 51 participants (estimated)
- Last updated on registry
- Aug 12, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Shuhua Yi, Doctor 📞 86-22-23909106 ✉ yishuhua@ihcams.ac.cn
- Lugui Qiu, Doctor 📞 86-22-23909172 ✉ qiulg@ihcams.ac.cn
Participating sites (1)
- Institute of Hematology & Blood Diseases HospitalRecruiting
Tianjin, Tianjin Municipality, 300020 · China
- Shuhua Yi, Dr. · 86-022-23909106 · yishuhua@ihcams.ac.cn
- Lugui Qiu, Dr. · 86-022-23909286 · qiulg@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- relapsed/refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- complete response
- No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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