Polatuzumab Vedotin
DrugPolatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
NCT Number: NCT06530511
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 2
Affiliated hospital of Nantong University, Nantong, Jiangsu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
Rituximab: 375 mg/m2, IV Drip infusion, D1
Orelabrutinib: 150 mg/time, qd, po, D1-21
Time frame: 6 months
Complete response rate (CRR) at the end of Induction treatment (6 cycles)
Time frame: 6 months
Overall response rate (ORR) at the end of Induction treatment (6 cycles)
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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.
Contact information is provided by the study sponsor or research team.
Affiliated Hospital of Nantong University
Other
A Prospective, Single-arm, Multicenter Clinical Study of Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Patients with Frail Treatment-naive Non-germinal Center Subtype Diffuse Large B-cell Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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