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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Yy-20394 combined with Gemcitabine and Oxaliplatin 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 Gemcitabine and Oxaliplatin was treated according to clinical standards.
objective remission rate
Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria
Time frame: with in 42 days after the first dos
disease control rate
Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria
Time frame: with in 42 days after the first dos
Progression Free Survival
Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria
Time frame: with in 42 days after the first dos
drug safety
Adverse events evaluated by NCI CTCAE v5.0
Time frame: one and half a year
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