Diffuse Large B Cell Lymphoma, DLBCL
Conditions
Interventions
1.2 mg/m2:Intravenous (IV) injection, 1.2 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
2.4 mg/m2:Intravenous (IV) injection, 2.4 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
4.0 mg/m2:Intravenous (IV) injection, 4.0 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
6.0mg/m2:Intravenous (IV) injection, 6.0 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
8.4 mg/m2:Intravenous (IV) injection, 8.4 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
11.2 mg/m2:Intravenous (IV) injection, 11.2 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
15 mg/m2:Intravenous (IV) injection, 15 mg/? once a day, administered at D1, D5, D7, D9, D12, D14, D16. Duration of dosing: 21 days.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years old, gender is not limited; 2. Hematological tumors, including but not limited to B-cell lymphoma, multiple myeloma, B Cell acute leukemia, T-cell lymphoma, T-cell acute leukemia, and patients with disease progression, relapse, or ineligibility for standard regimen therapy after standard regimen therapy (for specific definitions of relapsed or refractory disease, see Section 4.2); 3. Patients without serious organic lesions in the heart, lung, liver and kidney (LVEF (left ventricular ejection fraction =50%; total bilirubin =1.5×ULN; alanine aminotransferase (ALT) =1.5×ULN; aspartate aminotransferase); (AST) =1.5×ULN (; serum creatinine=1.5×ULN or CCr>40mL/min); 4. Those without severe coagulation dysfunction (PT=1.5×ULN, APTT=1.5×ULN, TT=1.5×ULN and FIB=1.0 g/L); 5. Patients without severe hematopoietic dysfunction (absolute neutrophil value =1.5×109/L, platelets =75×109/L, hemoglobin =80g/L), and no platelet, red blood cell, hemoglobin; 6. Patients received at least 4 weeks or more than 5 half-lives after the last antitumor treatment (chemotherapy, radiotherapy, biological therapy or immunotherapy) before enrollment; 7. Expected survival time = 12 weeks; 8. ECOG score =2 points; 9. Those who agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The toxicity of previous anticancer therapy has not recovered to grade I or below, or has not fully recovered from previous surgery; 2. Those with severe heart, lung, liver, kidney, digestive system diseases and chronic diseases of vital organs 3. Pregnant or breastfeeding female patients, fertile female/male patients who refuse to use contraceptive measures during the trial; 4. A history of acute myocardial infarction, congestive heart failure, unstable angina pectoris, or stroke within 6 months before enrollment; 5. Patients with impaired cardiac function (ejection fraction 1 mm or T wave inversion in two or more channels; congenital ventricular or Atrial arrhythmia, clinically significant tachycardia (>100 beats/min), bradycardia (450 ms (men), QTc >480 ms (women), or clinically significant cardiac Diseases (such as unstable angina, congestive heart failure, myocardial infarction within 6 months), etc.; 6. Those with central nervous system lymphoma/leukemia or mental disorders; 7. Have a history of organ transplantation; 8. Those with severe active infection; 9. Known severe hypersensitivity to the test drug and its excipients or HDAC inhibitors; 10. HCV antigen or antibody positive, HIV antigen or antibody positive, HBsAg positive, HBcAb positive and peripheral blood HBV DNA titer detection =1×103 IU/mL; 11. Alcohol dependence or drug abusers; 12. Those who have participated in clinical trials of other drugs within the past 1 month; 13. The investigators believe that there are other factors that are not suitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-72h;AUC0-8;MRT;Vd;t1/2;CLz/F;Vz/F;Ke; | — |
Countries
China
Contacts
Public ContactTing Niu
West China Hospital of Sichuan University
Outcome results
None listed