An interventional study of Induction therapy-Pro regimen and Consolidation therapy-Pro-pola regimen in Diffuse Large B-Cell Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
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.
1,389 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 349 are open to participants now.
This study's planned enrollment of 43 is close to the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow reserve is defined as:
Hemoglobin ≥8g/dL, platelet count ≥75×10\^9/L, Absolute neutrophil value ≥1.0×10\^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10\^9/L, absolute neutrophil count ≥0.75×10\^9/L.
Exclusion Criteria:
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 not achieving mRR (defined as complete remission \[CR\], partial remission \[PR\], and mini response \[miniR; lesion reduction: 25.0%-50.0%\]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
Drug: Induction therapy-Pro regimen · Drug: Consolidation therapy-Pro-pola regimen
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
Complete 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)
Plan to share: No
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Lymphoma, Large B-Cell, Diffuse→
The First Affiliated Hospital of Soochow University