yy-20394 、gemox treatment diffuse large b-cell lymphoma single arm, open, multicentrized phase 1b/2 clinical trial

Conditions: Diffuse Large B Cell Lymphoma

Summary: this study is a one-arm, open, multicenter phase 1b/2 clinical trial of yy-20394 combined with gemox second-line or above in patients with relapsed and/or refractory diffuse large b-cell lymphoma. yy-20394 combined with gemox was used as a cycle for 21 days. the dose of yy-20394 was 80mg/ day as recommended in phase 2, and the dose of gemox was treated according to clinical standards.

this study is a one-arm, open, multicenter phase 1b/2 clinical trial of yy-20394 combined with gemox second-line or above in patients with relapsed and/or refractory diffuse large b-cell lymphoma. yy-20394 combined with gemox was used as a cycle for 21 days. the dose of yy-20394 was 80mg/ day as recommended in phase 2, and the dose of gemox was treated according to clinical standards. the first six subjects of group to evaluate the safety of yy - 20394 joint gemox, if the joint treatment of 6 cases of subjects before, if yy-20394 and/or chemotherapy related 4 degrees of hematology toxicity or level 3 non hematologic toxicity were appearanced less than 2 cases, continued to dose of 80 mg/day, if more than 2 cases, yy-20394 doses dropped to 60 mg/day.

Eligibility criteria:
inclusion criteria: - patients with recurrent and/or refractory diffuse large b-cell lymphoma confirmed histologically or cytologically; progress after first-line or above systemic treatment (at least cd20 monoclonal antibody treatment); ecog performance status (ps) grade 0 \~ 1; expected survival ≥3 months; the patient has at least one measurable lesion conforming to the iwg2007 standard; good organ function level:anc≥1.0×109/l；plt≥70×109/l；hb≥80 g/l ;tbil≤1.5×uln； alt和ast≤2.5×uln；bun/urea和cr≤1.5×uln；lvef≥50%； the fridericia method corrected the qt interval (qtcf) for males \< 450 ms and females \< 470 ms. from the end of any previous anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy) to the washout period of this study ≥4 weeks; did not participate in the clinical trial as a subject within 1 month before the trial; according to the researcher's judgment, it can comply with the experimental protocol; volunteer to participate in this clinical trial, understand the study procedures and be able to sign the informed consent in person. exclusion criteria: * those who have used pi3k as the target of anti-tumor drug progression (except those who cannot tolerate out of the group); any other anti-tumor therapy within 4 weeks; the presence of a third interstitial effusion that cannot be controlled by drainage or other methods (such as massive pleural and ascites); use of steroid hormone dosage (equivalent amount of prednisone) greater than 20mg/ day within 4 weeks, and continuous use for more than 14 days; unable to swallow, chronic diarrhea and intestinal obstruction, existing multiple factors affecting drug intake and absorption; unable to suspend medications that may prolong qt interval during the study (e.g., antiarrhythmic agents); having lympoma with central nervous system (cns) invasion; allergic constitution, or known anaphylaxis to any component of this product; having active viral, bacterial or fungal infection requiring treatment (e.g., pneumonia); uncontrolled diabetes, pulmonary fibrosis, acute pulmonary disease, interstitial lung disease, or liver failure; patients with hbv, hcv infection (defined as hbsag and/or hbcab positive and hbv dna copy number ≥1×104 copy number /ml or ≥2000 iu/ml) or acute or chronic active hepatitis c; medical history of immunodeficiency, including hiv testing positive, or having other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; having received autologous hematopoietic stem cell transplantation within 90 days prior to the first dose in this study; any cardiac disease, including (1) angina pectoris; (2) arrhythmia requiring drug therapy or of clinical significance; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease that is judged by investigators as not suitable to participate in this trial; pregnant or lactating women or baseline pregnancy testing positive for fertile women; concomitant diseases (such as serious hypertension, diabetes mellitus, thyroid disease) seriously hazardous to patient's safety or completion of study as judged by the investigator; having other primary malignancy in recent 5 years;