Study of Prilinostat Mesylate for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant

This is an interventional other trial for Diffuse Large B Cell Lymphoma，DLBCL Read More

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 ;
• 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:

• 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 <45% detected by echocardiography or complete left bundle branch block with ECG ST segment downshift >1 mm or T wave inversion in two or more channels; congenital ventricular or Atrial arrhythmia, clinically significant tachycardia (>100 beats/min), bradycardia (<50 beats/min), ECG QTc >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 researchers conclud that there are other factors that are not suitable for participating in the trial.