Trial Outcomes & Findings for Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma (NCT NCT05498220)

Participants who signed consent, were deemed eligible, and began the study between 2/17/2023 and 1/07/2024 at a single center in North Carolina.

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification. Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT). Partial Response: Score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size on PET and ≥50% decrease in the sum of the products of diameters (SPD) of up to 6 target measurable nodes and extranodal sites on CT.

CR is defined as the number of subjects who received the study treatment, achieved complete response (CR) by the Lugano classification.

PFS is defined as the time from the start of study treatment until death, during which participants show no disease progression per Lugano criteria Progressive Disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG) -avid foci consistent with lymphoma at the interim or end-of-treatment assessment on PET, or an individual node/lesion must be abnormal with LDi \> 1.5 cm, increase by ≥ 50% from the cross product of the shortest axis perpendicular to LDi (SDi) nadir and an increase in LDi or SDi from nadir: 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm.

OS is the time from treatment start until death from any cause; participants still alive are censored.

The number of participants with adverse events will be listed and tabulated by grade to determine the safety and toxicity. Adverse Events will be graded according to The National Cancer Institute (NCI) of Common Terminology Criteria for Adverse Events (CTCAE) version 5. The scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

The number of participants with adverse events (AEs) will be tabulated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. AEs are reported with specific terms where possible (e.g., bacteremia, kidney infection, sepsis) under each Organ System Class to avoid repetition. Each AE term is graded as follows: Grade 1 (Mild; asymptomatic or mild symptoms, no intervention), Grade 2 (Moderate; minimal intervention, limits instrumental Activities of Daily Living), Grade 3 (Severe; hospitalization or disabling, limits self-care Activities of Daily Living), and Grade 4 (Life-threatening)