This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.
This prospective, multicenter, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of Pola-R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are unsuitable for autologous transplantation. The study aims to enroll 130 patients, all of whom will initially receive three cycles of Pola-R-GemOx. Subsequent treatment decisions will be based on therapeutic efficacy and transplant assessment. ① Patients achieving complete response (CR) or partial response (PR) after three cycles will proceed with an additional three cycles. Those achieving CR following six cycles will conclude treatment, while all other patients will transition to subsequent-line therapy. ② Patients who do not achieve CR or PR after three cycles will discontinue the regimen and proceed directly to subsequent-line therapy. The primary endpoint of the trial is the investigator-assessed objective response rate (ORR). Secondary endpoints include other efficacy measures, such as complete response rate (CR), event-free survival (EFS), 24-month progression-free survival (PFS) rate, overall survival (OS), and safety outcomes. Additionally, exploratory analyses will be conducted to identify potential predictors of clinical efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGInvetigator-assessed Objective Response Rate (ORR)
Defined as the proportion of all analyzable subjects achieving complete response (CR) and partial response (PR) after study initiation.
Time frame: Assessed up to 3 years
The CR rate assessed by the investigator
Defined as the proportion of all analyzable subjects achieving complete response (CR) after study initiation.
Time frame: Assessed up to 3 years
Event-free survival (EFS)
Defined as the time from the start of treatment to disease progression/recurrence, death from any cause, or the start of next line lymphoma therapy (NALT); Patients who had not experienced an event at the time of analysis were excluded from the most recent disease assessment date.
Time frame: Assessed up to 3 years
24-month progression-free survival (PFS) rate
PFS is defined as the time between the start of treatment and first recording to disease progression or death; Patients who had not experienced an event at the time of analysis were excluded from the most recent disease assessment date.
Time frame: Assessed up to 24 months
Overall survival time (OS)
Defined as the time from the start of treatment until death from any cause; Patients who had not experienced an event at the time of analysis were deleted on the date the patient was last known to be alive.
Time frame: Assessed up to 15 years
Security
The incidence of adverse events (AES), defined as all adverse events that occurred after a patient received the investigatory treatment regimen; The incidence of treatment-related AES was defined as the incidence of AEs associated with salvage therapy, transplantation, and consolidation therapy considered by the investigator after a patient received the investigational treatment.
Time frame: Assessed up to 3 years
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