Indolent T/NK cell lymphoma
Conditions
Interventions
Treatment group:PI3K inhibitor
Sponsors
Blood Disease Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, any gender; 2.Histologically confirmed relapsed or refractory T/NK cell lymphoma that has failed at least one systemic treatment or cannot tolerate it, and/or is currently without an effective standard treatment; 3.The patient meets the criteria for the corresponding treatment; 4.ECOG PS 0-2; 5.Sufficient organ function: ANC >= 1.0×10^9/L; PLT >= 70×10^9/L (can be relaxed to 50×10^9/L for patients with bone marrow infiltration); Hb >= 80 g/L (can be relaxed to 70 g/L for patients with bone marrow infiltration); TBIL = 50%; Fridericia-corrected QT interval (QTcF) male < 450 ms, female < 470 ms; 6.Expected survival of at least 3 months; 7.Male and female subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the last dose of the study medication; 8.Completed any prior anti-tumor treatment (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy) at least 4 weeks before the start of the trial; 9.No participation in other clinical trials within the past 1 month prior to enrollment; 10.The patient agrees to and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects who have previously used any PI3K inhibitors; 2.Clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with the adherence and/or absorption of the study drug; 3.Subjects who cannot interrupt medications that may prolong the QT interval (e.g., anti-arrhythmic drugs) during the study; 4.Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia); 5.HBV or HCV infected subjects (defined as positive for HBsAg and/or HbcAb with HBV DNA copy number >= the upper normal reference value) or those with acute or chronic active hepatitis C (HCV) antibody positive; 6.History of immune deficiency, including HIV positive, or other acquired or congenital immunodeficiencies, or a history of organ transplantation or allogeneic bone marrow or hematopoietic stem cell transplantation; 7.Autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of the study treatment; 8.Severe or uncontrolled cardiovascular disease; 9.Severe concomitant diseases that threaten patient safety or may impact the completion of the study, as judged by the investigator (e.g., uncontrolled hypertension, diabetes, thyroid disease); 10.Pregnant or breastfeeding women, or women with a positive baseline pregnancy test; 11.Other malignant tumors diagnosed or treated within the past 5 years; 12.Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events;Percentage of participants with complete response;Duration of Response;Time to response;Progression-Free-Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactShuhua Yi
Blood Disease Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Outcome results
None listed