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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro-pola regimen | Experimental | 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as complete remission [CR], partial remission [PR], and mini response [miniR; lesion reduction: 25.0%-50.0%]) were withdrawn from the study.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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction therapy-Pro regimen | Drug | Pro regimen induction(21days per cycle*1 cycle)
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) | The rate of patients who achieved CR after 6 cycles of Pro-pola regimen | At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | The rate of patients who achieved CR or PR after 6 cycles of Pro-pola regimen | At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days) |
| 2-year progression-free survival(PFS) |
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Inclusion Criteria:
Age ≥70 years unfit or frail
There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
Histologically confirmed treatment-naive DLBCL.
Life expectancy is>3 months.
appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
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.
Patients have the ability to understand and are willing to provide written informed consent.
Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin | Contact | 67781856 | jinzhengming519519@163.com | |
| Changju Qu | Contact | 67781865 | qcj310@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhengming Jin | The First Affiliated Hospital of Soochow University | Study Chair |
| Changju Qu | The First Affiliated Hospital of Soochow University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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|
| Consolidation therapy-Pro-pola regimen | Drug | 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 |
|
PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.
| 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. | 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. | From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days) |
| Nana Ping |
| The First Affiliated Hospital of Soochow University |
| Principal Investigator |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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