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This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO | Experimental | The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles. The dose and administration method of the study drug were as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab vedotin | Drug | Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CRR | Complete response rate (CRR) at the end of Induction treatment (6 cycles) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall response rate (ORR) at the end of Induction treatment (6 cycles) | 6 months |
| 2y-PFS rate | defined as the time from the start of treatment to the first documented Disease progression or Death; patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Potential predictive factors | defined as clinical and biological factors at baseline or during the treatment that might be associated with treatment efficacy and safety and was performed to screen out populations that would benefit more from this protocol. | 24 months |
Inclusion Criteria:
Patients with histopathologically confirmed DLBCL;
The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;
Non-germinal center (Non-GCB) type;
ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder > 1.5 cm, or at least one extranodal lesion > 1.0 cm in the longest diameter; ⑦ Adequate organ function;
Exclusion Criteria:
Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;
Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC < 1.5 x 109/L, PLT < 80 x 109/L b) Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c) Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d) Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance < 60 mL/min (estimated by C OC kcroft-Gault formula); ③ HIV Infection;
HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenyu Shi | Contact | +86 13515203737 | shiwenyu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226005 | China |
all IPD that underlie results in publication
starting 6 months after publication
IPD could be shared by contacting the corresponding author via email after publication
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| Rituximab |
| Drug |
Rituximab: 375 mg/m2, IV Drip infusion, D1 |
|
| Orelabrutinib | Drug | Orelabrutinib: 150 mg/time, qd, po, D1-21 |
|
| 24 months |
| OS | defined as the time from the start of treatment to the Death of death from any cause; patients who had not experienced an event at the time of analysis were censored at the date the patient was last known to be alive | 24 months |
| EFS | defined as the time from the start of treatment until Disease progression/relapse, Death from any cause, or the start of next-line Lymphoma therapy (NALT); patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment | 24 months |
| Safety profile | defined as the incidence of Adverse event (AEs) that occurred from the date of the first dose of Carcinoma until 30 days after discontinuation of study drug or PD or initiation of new anti-safety therapy, whichever occurred first, and defined as all Adverse event that occurred after the patient received the study regimen; defined as the incidence of treatment-related AEs that were considered by the investigator to be related to Salvage therapy, Transplant, and consolidation therapy after the patient received the study regimen | 24 months |
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | China |
|
| 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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| ID | Term |
|---|---|
| C000600736 | polatuzumab vedotin |
| D000069283 | Rituximab |
| C000729508 | orelabrutinib |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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