Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL
Diffuse Large B Cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring LYMPHOMA, DLBCL, ASCT, VENETOCLAX
Eligibility Criteria
Inclusion Criteria: According to world Health Organization (WHO) classification of disease, DLBCL was confirmed by histology, relapsed or refractory after first-line treatment, and CR or PR after upfront treatment; 18≤ age ≤65 years old, male or female; Bcl-2 positive rate >50% according to immunohistochemistry of biopsied tissue; No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, hemoglobin ≥90g/L, platelet ≥75×109/L; Total bilirubin ≤1.5× upper normal value (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× upper normal value (ULN); Creatinine clearance was 44-133 mmol/L; ECOG score 0-1; The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure. Exclusion Criteria: Previously received autologous hematopoietic stem cell transplantation; Suffering from serious complications or severe infection; Previously treated with Venetoclax; Central nervous system lymphoma was excluded; Suffering from serious complications or severe infection; A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes; Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.; HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative; Laboratory test value during screening; Neutrophils <1.5×109/L; Platelet <75×109/L; Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit; The creatinine level is higher than 1.5 times the upper limit of normal value; Left ventricular ejection fraction ≦ 50%; Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study; Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol; Pregnant or lactating women; The researcher judged that the patients were not suitable for this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
V-BEAM
BEAM
Patients in this arm will receive Venetoclax Combined With BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.
Patients in this arm will receive BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.