To evaluate the efficacy and safety of the Pro-Pola (Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib),following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Pro regimen induction(21days per cycle\*1 cycle) * Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle * Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle * Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle
Pro-pola regimen consolidation(21days per cycle\*6 cycle) -Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle -Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle -Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle -Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete response rate(CRR)
The rate of patients who achieved CR after 6 cycles of Pro-pola regimen
Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
Objective response rate(ORR)
The rate of patients who achieved CR or PR after 6 cycles of Pro-pola regimen
Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
2-year progression-free survival(PFS)
PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.
Time frame: From the enrollment to 2-year after the treatment of last patient
2-year overall survival(OS)
OS will be assessed from the start the treatment to date of death or end of follow-up.
Time frame: From the enrollment to 2-year after the treatment of last patient
Main adverse reactions
The safety of the therapeutic regimen measured by the major adverse events.
Time frame: From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days)
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