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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
zanubrutinib:160mg oral bid D-8-D-2 camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2
camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2
Progression-free survival
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.
Time frame: Baseline up to data cut-off (up to approxiamately 2 years)
Overall survival
Overall survival was defined as the time from the date of ASCT to the date of death from any cause
Time frame: Baseline up to data cut-off (up to approxiamately 2 years)
Complete remission rate
Percentage of participants with complete response was determined on 2014 Lugano criteria
Time frame: 3 months after the transplantation
The time of hematopoietic reconstruction
The first day of neutrophils ≥0.5\*109/L for 3 consecutive days was the time of successful implantation of granulocytes. Platelet ≥20.0\*109/L for 7 consecutive days and the first day after platelet infusion was considered as the successful time of megakaryocytes implantation
Time frame: 2 months after the transplantation
Transplantation-related adverse reactions
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT.
Time frame: Baseline up to data cut-off (up to approxiamately 4 years)
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