a study of yy-20394 in patients with relapsed or refractory peripheral t/nk cell lymphoma

Conditions: PTCL

Summary: a single-arm, open, multicenter study to investigate the efficacy and safety of yy-20394, an oral small molecular inhibitor of pi3k-delta, in patients with relapsed or refractory peripheral t/nk cell lymphoma.


Eligibility criteria:
inclusion criteria: * males and/or females over age 18. * histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral t/nk cell lymphoma. * eastern cooperative oncology group performance status of 0 to 1. * life expectancy of at least 3 months. * at least one measurable lesion according to lugano 2014. * adequate organ function. * had anti-tumor treatment within 2 weeks prior to the first dose of investigational product (including tki, chinese herbal anti-tumor treatment); within 4 weeks prior to the first dose of investigational product (including chemotherapy, radiotherapy, immunotherapy and major surgery); other targeted therapies with 5 half-life period prior to the first dose. * men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose. * volunteers did not participate in other clinical trials within 1 month prior to study entry. * provision of signed and dated, written informed consent prior to any study- specific evaluation. exclusion criteria: * previous treatment with any pi3k-delta inhibitors. * uncontrolled pleural effusion and ascites. * the dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days. * medical conditions in swallowing difficulty, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/ or absorption of the investigational agent. * drugs that may prolong the qt (such as anti-arrhythmic drugs) could not be interrupted during the study period. * evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression. * have active viral, bacterial, fungal, or other infections that require systematic treatment (e.g., active tuberculosis), excluding nail bed fungal infections. * active infection with hepatitis b and c virus (volunteers with hbsag or hbcab positive but hbv-dna negative, or hcv antibody positive but hcv-rna negative can be enrolled). * history of immune deficiency (acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease (e.g., autoimmune enteritis and systemic lupus erythematosus). * prior autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study drug. * presence of severe or uncontrolled cardiovascular disease. * medical history of active bleeding within 2 months prior to study entry, or currently achieved anticoagulant therapy, or susceptible to bleed by the judgement of investigator. * presence of concomitant diseases that are seriously endanger the safety of patient or affect the completion of the study by the investigator's judgment (e.g., uncontrolled hypertension, diabetes, thyroid diseases). * had received gcsf or blood transfusion treatment within 14 days prior to study entry. * female subjects of childbearing potential have a positive pregnancy test at the baseline. * medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor. * adverse events occurred during previous anticancer therapy have not been recovered to ≤1 (ctcae 5.0) except toxicity with no significant risk determined by investigator such as alopecia. * live vaccine was administered within 30 days prior to the first dose of the investigational drug, or was scheduled to be administered during the study period. * judgment by the investigator that the volunteer should not participate in the study.