This trial is a prospective, multi-center, single-arm clinical research. The intention is to evaluate the efficacy and safety of pirtobrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients.
A total of 28 patients with relapsed/refractory DLBCL are planned to be enrolled in this trial. They will receive pirtobrutinib in combination with the BEAM regimen as conditioning therapy, followed by ASCT. The study comprises a screening period, a treatment period (days -8 to -2, 7 days in total), and a 2-year follow-up period after transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
pirtobrutinib 200mg oral qd 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: 70mg/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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