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

NCT05863845 | Unknown

• 1 other identifier: V-BEAM
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

LYMPHOMA; DLBCL; ASCT; VENETOCLAX

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (4)

• Overall survival

  Baseline up to data cut-off (up to approximately 2 years)

• Complete remission rate

  Baseline up to data cut-off (up to approximately 2 years)

• The time of hematopoietic reconstruction

  Baseline up to data cut-off (up to approximately 2 years)

• Transplantation-related adverse reactions

  Baseline up to data cut-off (up to approximately 2 years)

Study Arms (2)

V-BEAM

EXPERIMENTAL

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.

Drug: Venetoclax; Drug: Carmustine; Drug: Cytarabine; Drug: Etoposide; Drug: Melphalan; Procedure: Hematopoietic Cell Transplantation

BEAM

SHAM COMPARATOR

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.

Drug: Carmustine; Drug: Cytarabine; Drug: Etoposide; Drug: Melphalan; Procedure: Hematopoietic Cell Transplantation

Interventions

Venetoclax DRUG

100mg day -10, 200mg day -9, 400mg day -8, 800mg day -7 to -1, Given PO

V-BEAM

Carmustine DRUG

300mg/m2 day -7, Given IV

BEAM; V-BEAM

Cytarabine DRUG

100mg/m2/d, day -6 to day -3, Given IV

BEAM; V-BEAM

Etoposide DRUG

200mg/m2/d, day -6 to day -3, Given IV

BEAM; V-BEAM

Melphalan DRUG

140mg/m2, day -2, Given IV

BEAM; V-BEAM

Hematopoietic Cell Transplantation PROCEDURE

Undergo hematopoietic cell transplantation

BEAM; V-BEAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

venetoclax; Carmustine; Cytarabine; Etoposide; Melphalan; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Weili Prof. Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Prof. Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05