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New treatment option for Lymphoma, T-Cell
Official title PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
ClinicalTrials.gov ID: NCT06530550
What this study is testing
What is PI3K inhibitor?
PI3K inhibitor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lymphoma, t-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage...
You likely can't join if
- Here is the translated text:
- people 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...
- 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...
See the full eligibility 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...
- Here is the translated text:
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.