18 and older, any sex, with Diffuse Large B-cell Lymphoma (DLBCL). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main CohortPrimary· 60 months
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first.
Response was assessed according to Evaluation Criteria in diffuse large B cell lymphoma studies (based on Cheson Response criteria and the Lugano Classification (2014))
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
54.5
44.2 – 64.6
Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Cohort A & in All PatientsSecondary· 5 years
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first.
Group
Value
95% CI
Tisagenlecleucel - Cohort A
43.8
19.8 – 70.1
Tisagenlecleucel - All Patients
53.0
43.5 – 62.4
Time to Response (TTR) as Assessed by Independent Review Committee (Main Cohort & All Patients)Secondary· up to approx. 3.3 months
TTR is the time between date of CTL019 infusion until first documented response (CR or PR).
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
1.0
0.9 – 1.0
Tisagenlecleucel - All Patients
1.0
0.9 – 1.0
Duration of Overall Response (DOR) Per IRCSecondary· up to approx. 60.1 months
DOR is the time from achievement of CR or PR, whichever occurs first, to relapse or death due to diffuse large B-cell lymphoma (DLBCL).
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
NA
10.0 – NA
Tisagenlecleucel - Cohort A
NA
1.2 – NA
Tisagenlecleucel - All Patients
NA
10.0 – NA
Event Free Survival (EFS) Per Independent Review CommitteeSecondary· up to approx. 61 months
EFS is the time from date of CTL019 infusion to the date of first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
2.8
2.2 – 3.5
Tisagenlecleucel - Cohort A
2.1
1.0 – 3.1
Tisagenlecleucel - All Patients
2.8
2.1 – 3.1
Progression Free Survival (PFS) Per Independent Review CommitteeSecondary· up to approx. 61 months
PFS is the time from date of CTL019 infusion to the date of first documented disease progression or death due to any cause.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
3.0
2.4 – 6.2
Tisagenlecleucel - Cohort A
2.9
1.0 – NA
Tisagenlecleucel - All Patients
2.9
2.3 – 5.2
Overall Survival (OS) Per Independent Review CommitteeSecondary· 60 months
OS is the time from date of CTL019 infusion to the date of death due to any cause.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort
12.5
7.2 – 34.2
Tisagenlecleucel - Cohort A
5.9
3.1 – 19.2
Tisagenlecleucel - All Patients
11.1
6.6 – 23.9
Pharmacokinetics (Pk): CmaxSecondary· 60 months
Cmax is the maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration. Cmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort: CR/PR
5570
± 271.3
Tisagenlecleucel - Main Cohort: SD/PD/UNK
4690
± 481.1
Tisagenlecleucel - Cohort A: CR/PR
14300
± 67.5
Tisagenlecleucel - Cohort A: SD/PD/UNK
6950
± 109.3
Pharmacokinetics (Pk): TmaxSecondary· 60 months
Tmax is the time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days). Tmax, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. The time frame of 60 months refers to the duration for which the data were reviewed to identify the time of Cmax for this measure.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort: CR/PR
9.84
5.78 – 27.7
Tisagenlecleucel - Main Cohort: SD/PD/UNK
8.95
0.994 – 26.7
Tisagenlecleucel - Cohort A: CR/PR
6.95
5.94 – 8.96
Tisagenlecleucel - Cohort A: SD/PD/UNK
6.93
6.67 – 10.9
Pharmacokinetics (Pk): AUC0-28d and AUC0-84dSecondary· 0 - 28 days after infusion for AUC0-28d, 0 - 84 days after infusion for AUC0-84d
The AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood. AUC0-28d and AUC0-84d, based on the transgene level data by qPCR, were summarized by Month 3 response, per Independent Review Committee assessment.
AUC0-28d
Group
Value
95% CI
Tisagenlecleucel - CR/PR
58000
± 182.1
Tisagenlecleucel - Main Cohort: SD/PD/UNK
49900
± 388.5
Tisagenlecleucel - Cohort A: CR/PR
141000
± 78.2
Tisagenlecleucel - Cohort A: SD/PD/UNK
63700
± 134.2
AUC0-84d
Group
Value
95% CI
Tisagenlecleucel - CR/PR
102000
± 171.7
Tisagenlecleucel - Main Cohort: SD/PD/UNK
92900
± 165.4
Tisagenlecleucel - Cohort A: CR/PR
206000
± 76.7
Tisagenlecleucel - Cohort A: SD/PD/UNK
142000
± 61.3
Pharmacokinetics (Pk): T1/2Secondary· 60 months
T1/2 is the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve in peripheral blood. T1/2, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame of 60 months reflects the maximum duration up to which the transgene levels were collected to measure the half life.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort: CR/PR
167
± 355.3
Tisagenlecleucel - Main Cohort: SD/PD/UNK
10.9
± 205.4
Tisagenlecleucel - Cohort A: CR/PR
59.4
± 30402.1
Tisagenlecleucel - Cohort A: SD/PD/UNK
15.6
± 163.5
Pharmacokinetics (Pk): ClastSecondary· 60 months
Clast is the last observed quantifiable concentration in peripheral blood. Clast, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame reflects maximum duration of 60 months up to which the transgene levels were collected.
Group
Value
95% CI
Tisagenlecleucel - Main Cohort: CR/PR
181
± 114.4
Tisagenlecleucel - Main Cohort: SD/PD/UNK
332
± 430.9
Tisagenlecleucel - Cohort A: CR/PR
272
± 30.6
Tisagenlecleucel - Cohort A: SD/PD/UNK
386
± 540.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tisagenlecleucel - All Patients
Serious: 84/115 (73%)
Deaths: 76/115
Serious adverse events (106 terms)
Reaction
System
Tisagenlecleucel - All Pat…
Cytokine release syndrome
Immune system disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Pyrexia
General disorders
—
Pneumonia
Infections and infestations
—
Fatigue
General disorders
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Encephalopathy
Nervous system disorders
—
Acute kidney injury
Renal and urinary disorders
—
Pancytopenia
Blood and lymphatic system disorders
—
Multiple organ dysfunction syndrome
General disorders
—
Clostridium difficile infection
Infections and infestations
—
Sepsis
Infections and infestations
—
Neutrophil count decreased
Investigations
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 18 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02445248.