A Single-center, Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL
Overview
- Phase
- Phase 2
- Intervention
- zanubrutinib combined with BEAM
- Conditions
- DLBCL
- Sponsor
- Ruijin Hospital
- Enrollment
- 66
- Primary Endpoint
- Progression-free survival
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.
Detailed Description
This trial includes 66 patients with recurrent or refractory DLBCL, who will be randomly divided into a 1:1 combination of zanubrutinib and BEAM regimen pretreatment (experimental group) or a standard BEAM regimen pretreatment (control group), and then undergo ASCT treatment. The entire trial includes a screening period (before the start of autologous stem cell transplantation pretreatment), a treatment period (-8 days to -2 days, a total of 7 days), and a follow-up period (2 years after autologous stem cell transplantation)
Investigators
Zhao Weili
professor
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- •According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;
- •18≤ age ≤65 years old, male or female;
- •ECOG score 0-2;
- •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× ULN; Bilirubin ≤1.5× ULN
- •Creatinine clearance was 44-133 mmol/L;
- •No cardiac dysfunction;
- •Life expectancy over 3 months;
Exclusion Criteria
- •Previously received autologous hematopoietic stem cell transplantation;
- •Suffering from serious complications or severe infection;
- •Previous treatment with selinexor;
- •Central nervous system lymphoma was excluded;
- •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;
- •Left ventricular ejection fraction ≦ 50%;
- •Laboratory test value during screening;
- •① Neutrophils \<1.5×109/L; Platelet \<75×109/L;
Arms & Interventions
zanubrutinib combined with BEAM
zanubrutinib combined with camustine, etoposide, cytarabine, and mafaran (BEAM)
Intervention: zanubrutinib combined with BEAM
BEAM
camustine, etoposide, cytarabine, and mafaran (BEAM)
Intervention: BEAM
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Baseline up to data cut-off (up to approxiamately 2 years)
Progression-free survival was defined as the time from the data of ASCT until the date of the first documented day of disease progression or relapse, using Lugano criteria, or death from an cause, whichever occured first.
Secondary Outcomes
- Overall survival(Baseline up to data cut-off (up to approxiamately 2 years))
- Complete remission rate(3 months after the transplantation)
- The time of hematopoietic reconstruction(2 months after the transplantation)
- Transplantation-related adverse reactions(Baseline up to data cut-off (up to approxiamately 4 years))