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NCT03568461: ELARA

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Completed Phase 2 Results posted Last updated 7 October 2025
What this trial tests

Phase 2 trial testing tisagenlecleucel in Follicular Lymphoma in 98 participants. Completed in 28 May 2025.

Timeline
12 November 2018
Primary endpoint
24 November 2020
28 May 2025

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment98
Start date12 November 2018
Primary completion24 November 2020
Estimated completion28 May 2025
Sites31 locations across France, Italy, Japan, Netherlands, Belgium, Austria, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Follicular Lymphoma. 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.

Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment Primary · 1 year

Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible respo

GroupValue95% CI
CTL01969.158.8 – 78.3
Overall Response Rate (ORR) Per IRC Assessment Secondary · 1 year

Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point sc

GroupValue95% CI
CTL01986.277.5 – 92.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 24 months for each patient.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CTL019
Serious: 42/97 (43%)
Deaths: 7/97

Serious adverse events (45 terms)

ReactionSystemCTL019
Cytokine release syndromeImmune system disorders
PneumoniaInfections and infestations
Febrile neutropeniaBlood and lymphatic system disorders
PyrexiaGeneral disorders
NeutropeniaBlood and lymphatic system disorders
Infusion related reactionInjury, poisoning and procedural complications
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
EncephalopathyNervous system disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
Ventricular fibrillationCardiac disorders
BlindnessEye disorders
Gastrointestinal ulcerGastrointestinal disorders
GlossitisGastrointestinal disorders
NauseaGastrointestinal disorders
StomatitisGastrointestinal disorders
VomitingGastrointestinal disorders
Catheter site haemorrhageGeneral disorders
Graft versus host disease in gastrointestinal tractImmune system disorders
BacteraemiaInfections and infestations
COVID-19Infections and infestations
COVID-19 pneumoniaInfections and infestations
DiverticulitisInfections and infestations
Human herpesvirus 6 encephalitisInfections and infestations
Localised infectionInfections and infestations
Other adverse events (48 terms — click to expand)

ReactionSystemCTL019
NeutropeniaBlood and lymphatic system disorders
Cytokine release syndromeImmune system disorders
AnaemiaBlood and lymphatic system disorders
HeadacheNervous system disorders
DiarrhoeaGastrointestinal disorders
White blood cell count decreasedInvestigations
ThrombocytopeniaBlood and lymphatic system disorders
Neutrophil count decreasedInvestigations
FatigueGeneral disorders
PyrexiaGeneral disorders
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
HypogammaglobulinaemiaImmune system disorders
CoughRespiratory, thoracic and mediastinal disorders
Platelet count decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
Lymphocyte count decreasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
HypophosphataemiaMetabolism and nutrition disorders
PruritusSkin and subcutaneous tissue disorders
Febrile neutropeniaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
LymphopeniaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
HypomagnesaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
HypotensionVascular disorders
Abdominal painGastrointestinal disorders
ChillsGeneral disorders
Upper respiratory tract infectionInfections and infestations
Decreased appetiteMetabolism and nutrition disorders
DizzinessNervous system disorders
AstheniaGeneral disorders
NasopharyngitisInfections and infestations
SARS-CoV-2 test negativeInvestigations
Weight decreasedInvestigations
Muscle spasmsMusculoskeletal and connective tissue disorders
InsomniaPsychiatric disorders
RashSkin and subcutaneous tissue disorders

Most-reported serious reactions: Cytokine release syndrome, Pneumonia, Febrile neutropenia, Pyrexia, Neutropenia, Infusion related reaction, Squamous cell carcinoma, Encephalopathy.

Data from ClinicalTrials.gov NCT03568461 adverse events section.

Sponsor's own description

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.
    Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, et al · · 2022 · cited 403× · PMID 34921238 · DOI 10.1038/s41591-021-01622-0
  2. Current status and perspective of CAR-T and CAR-NK cell therapy trials in Germany.
    Albinger N, Hartmann J, Ullrich E. · · 2021 · cited 171× · PMID 33753909 · DOI 10.1038/s41434-021-00246-w
  3. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
    Westin JR, Kersten MJ, Salles G, Abramson JS, et al · · 2021 · cited 163× · PMID 34310745 · DOI 10.1002/ajh.26301
  4. The journey of CAR-T therapy in hematological malignancies.
    Lu J, Jiang G. · · 2022 · cited 148× · PMID 36209106 · DOI 10.1186/s12943-022-01663-0
  5. Infectious complications, immune reconstitution, and infection prophylaxis after CD19 chimeric antigen receptor T-cell therapy.
    Wudhikarn K, Perales MA. · · 2022 · cited 105× · PMID 35840746 · DOI 10.1038/s41409-022-01756-w
  6. CAR-T cell therapy for cancer: current challenges and future directions.
    Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
  7. State of the art in CAR T cell therapy for CD19+ B cell malignancies.
    Frigault MJ, Maus MV. · · 2020 · cited 77× · PMID 32235098 · DOI 10.1172/jci129208
  8. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update.
    Dreyling M, Fowler NH, Dickinson M, Martinez-Lopez J, et al · · 2024 · cited 76× · PMID 38194692 · DOI 10.1182/blood.2023021567

Verify or expand the search:

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Trials by the same sponsor.

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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/NCT03568461.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing