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

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

NCT ID: NCT05863845

Condition: Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Cytarabine
Etoposide
Melphalan
Venetoclax
Carmustine

Conditions: Keywords:
LYMPHOMA
DLBCL
ASCT
VENETOCLAX

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Venetoclax
Description: 100mg day -10, 200mg day -9, 400mg day -8, 800mg day -7 to -1, Given PO
Arm group label: V-BEAM

Intervention type: Drug
Intervention name: Carmustine
Description: 300mg/m2 day -7, Given IV
Arm group label: BEAM
Arm group label: V-BEAM

Intervention type: Drug
Intervention name: Cytarabine
Description: 100mg/m2/d, day -6 to day -3, Given IV
Arm group label: BEAM
Arm group label: V-BEAM

Intervention type: Drug
Intervention name: Etoposide
Description: 200mg/m2/d, day -6 to day -3, Given IV
Arm group label: BEAM
Arm group label: V-BEAM

Intervention type: Drug
Intervention name: Melphalan
Description: 140mg/m2, day -2, Given IV
Arm group label: BEAM
Arm group label: V-BEAM

Intervention type: Procedure
Intervention name: Hematopoietic Cell Transplantation
Description: Undergo hematopoietic cell transplantation
Arm group label: BEAM
Arm group label: V-BEAM

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.

Detailed description: Diffuse Large B-cell lymphoma (DLBCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas with different pathogenesis and clinical prognosis. Despite the survival benefits of Anthracycline-based chemotherapy bridging autologous stem cell transplantation (ASCT), 30%-40% of DLBCL patients fail to respond to treatment and relapse or die within a short period of time. A phase I/II trial of Venetoclax combined with BEAM as a pretreatment regimen for ASCT of high-risk and relapsed/refractory lymphoma was presented at the ASH Meeting 2021 (NCT03583424), and it studies the side effects and best dose of venetoclax when given together with BEAM (carmustine, etoposide, cytarabine, and melphalan) before stem cell transplant in treating participants with relapsed or refractorynon-Hodgkin lymphoma. The results confirmed that Venetoclax has a good prospect in ASCT.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Start date: June 1, 2023

Completion date: November 30, 2025

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05863845