This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
R-CHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Vincristine: 1.4 mg/m², Day 1 (maximum single dose: 2 mg) Prednisone: 100 mg, Days 1-5 Orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
POLA-R-CHP+orelabrutinib Rituximab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
R-miniCHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
POLA-Hi-CHP+orelabrutinib Zuberitamab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Hi-miniCHOP Regimen Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
RMTO Regimen Rituximab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
HiMTO Regimen Zuberitamab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Pola-R-miniCHP Regimen Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Rituximab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Pola-Hi-miniCHP Regimen (21-day cycle, up to 6 cycles) Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Zuberitamab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
2year PFS
The percentage of subjects who had not experienced disease progression or all-cause death at 24 months from first dose, relative to the total enrolled population.
Time frame: From the start of treatment up to 2 years
ORR
The proportion of patients who achieved a PR or better response at the end of therapy
Time frame: From the start of treatment up to 2 years
CRR
Proportion of patients achieving CR at the end of treatment
Time frame: From the start of treatment up to 2 years
OS
Time from treatment initiation to death from any cause
Time frame: From the start of treatment up to 2 years
AEs
All adverse medical events that occurred after the initiation of treatment
Time frame: From the start of treatment up to 2 years
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