Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This single-center, randomized clinical study will evaluate the efficacy and safety of Venetoclax combined with BEAM Pretreatment Regimen in ASCT treatment of DLBCL patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Carmustine; Cytarabine; Etoposide; Melphalan; Venetoclax

Criteria

Inclusion Criteria:

1. 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;

2. 18≤ age ≤65 years old, male or female;

3. Bcl-2 positive rate >50% according to immunohistochemistry of biopsied tissue;

4. 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;

5. ECOG score 0-1;

6. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.

Exclusion Criteria:

1. Previously received autologous hematopoietic stem cell transplantation;

2. Suffering from serious complications or severe infection;

3. Previously treated with Venetoclax;

4. Central nervous system lymphoma was excluded; Suffering from serious complications or severe infection;

5. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;

6. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;

7. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;

8. 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;

9. Left ventricular ejection fraction ≦ 50%;

10. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;

11. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;

12. Pregnant or lactating women;

13. The researcher judged that the patients were not suitable for this study.