recurrent or refractory hematologic tumors dominated by b-cell associated tumors
Conditions
Interventions
Group 1:Start dosage 1.2mg/m2
Group 2:Increase dosage to 2.4mg/m2
Group 3:Increase dosage to 4.0mg/m2
Group 4:Increase dosage to 6.0mg/m2
Group 5:Increase dosage to 8.4mg/m2
Group 6:Increase dosage to 11.2mg/m2
Group 7:Increase dosage to 15mg/m2
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, male or female; 2. The histopathology and cytology diagnosis (according to the "standard of blood disease diagnosis and curative effect" (the fourth edition) (science press) for blood system tumor, including but not limited to, B cell lymphoma, multiple myeloma, acute leukemia cells, T cell lymphoma, B T cells of acute leukemia, and after treatment with standard solution in disease progression, recurrence, or don't fit in patients receiving standard treatment (recurrent or refractory disease, see section 4.2); 3. Heart, lung, liver and kidney function indexes: LVEF (left ventricular ejection fraction) >=50%; Total bilirubin 40mL/min); 4. coagulation dysfunction: PT= 1.0g /L); 5. hematopoietic indexes: absolute value of neutrophils >=1.5x10^9/L, platelet >=75x10^9/L, hemoglobin >=80g/L), and no platelets, erythrocytes, or hemoglobin were injected within 2 weeks before screening; 6. Patients received at least 4 weeks or more than 5 half-lives after the previous anti-tumor treatment (chemotherapy, radiotherapy, biotherapy or immunotherapy) before enrollment; 7. Expected survival time >=12 weeks; 8. Grade of ECOG<=2; 9. Those who agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Toxicity of previous anticancer therapy did not return to grade I or below, or did not fully recover from previous surgery; 2. Severe lung, liver, kidney, digestive system diseases and chronic diseases of vital organs; 3. Female patients during pregnancy or lactation and female/male patients with fertility who refused to use contraception during the trial; 4. History of acute myocardial infarction, congestive heart failure with NYHA grade >=2, unstable angina pectoris or stroke within 6 months before admission; 5. Impaired cardiac function (ejection fraction 1mm or T wave inversion in two or more channels;Congenital ventricular or atrial arrhythmia, clinical significant tachycardia (> 100 times/min), bradycardia ( 450 ms (men), QTc > 480 ms (female) or clinically significant heart disease (such as unstable angina pectoris, congestive heart failure, myocardial infarction occurred within 6 months), etc.; 6. Have central nervous system lymphoma/leukemia or mental disorders; 7. A history of organ transplantation; 8. There are severe active infections; 9. Severe allergies to test drugs and their excipients or HDAC inhibitors are known; 10. Positive HCV antigen or antibody, positive HIV antigen or antibody, HBsAg positive, HBcAb positive, and the detection of peripheral blood HBV DNA titer >=1×10^3 IU/mL; 11. Alcohol dependence or drug abuse; 12. Have participated in other drug clinic in the past 1 month; 13. The researchers determined that there were other factors that were unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of Preisinastat Mesylate in plasma;Acetylation levels of histone H3 and H4 (for leukemia patients only); | — |
Countries
China
Contacts
Public ContactYongsheng Wang, Ting Niu
West China Hospital, Sichuan University
Outcome results
None listed