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Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL | Clinical Trials | Clareo Health

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

Efficacy and Safety of Venetoclax Combined With BEAM (Carmustine, Etoposide Cytarabine and Melphalan) Pretreatment in Autologous Stem Cell Transplantation for Diffuse Large B-cell Lymphoma: a Single-center, Randomized Clinical Study

NCT05863845•Ruijin Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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;
+6 more criteria

Key Dates

Start Date

June 1, 2023

Primary Completion Date

November 30, 2024

Completion Date

November 30, 2025

Last Updated

May 18, 2023

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B Cell Lymphoma

Interventions

Venetoclax

DRUG

Carmustine

DRUG

Cytarabine

DRUG

Etoposide

DRUG

Melphalan

DRUG

Hematopoietic Cell Transplantation

PROCEDURE

Contacts

Weili Prof. Zhao

CONTACT

+862164370045 zwl_trial@163.com

Pengpeng Prof. Xu

CONTACT

+862164370045 pengpeng_xu@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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