Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators |
CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake = mediastinum), 3 (uptake > mediastinum but = liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to = 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method. |
First infusion date up to maximum duration of 32.7 months |
|
| Secondary |
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) |
An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion. |
First infusion date up to maximum duration of 27 months |
|
| Secondary |
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value |
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented. |
First infusion date up to maximum duration of 27 months |
|
| Secondary |
Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators |
ORR: percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake = mediastinum), 3 (uptake > mediastinum but = liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to = 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT). PRR: = 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal; no new sites. |
First infusion date up to maximum duration of 32.7 months |
|
| Secondary |
Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators |
DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression [progressive metabolic disease (PMD); progressive radiologic disease (PRD)] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; = 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions =1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported. |
From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months) |
|
| Secondary |
Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators |
PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported. |
First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months) |
|
| Secondary |
Overall Survival (OS) |
OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported. |
First infusion date up to death regardless of cause (up to approximately 32.7 months) |
|
| Secondary |
Peak Level of Anti-CD19 CAR T Cells in Blood |
Peak was defined as the maximum number of CAR T cells in blood measured after infusion. |
Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
|
| Secondary |
Level of Anti-CD19 CAR T Cells in Blood by Visit |
|
Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
|
| Secondary |
Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) |
AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28. |
Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28 |
|
| Secondary |
Time to Peak Level of Anti-CD19 CAR T Cells in Blood |
Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion. |
Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
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