Trial reportBlood advances2022
Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma.
Trial report in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03568461 (A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel), which is not on this map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Who cites it
23 citing papers in PubMed, 42 citations in OpenAlex.
- Trial
- Trial
- Effectiveness of CAR-T Cell Therapies for Relapsed/Refractory Follicular Lymphoma: An External Control Arm Study.Cancer research and treatment · 2026Article
- Advances in T-Cell-Directed Immunotherapy for Adult Mature B-Cell Lymphoma: A Comprehensive Review of CAR T-Cell and Bispecific Antibody Therapies.Cancer research and treatment · 2025Review
- Follicular lymphoma or diffuse large B-cell lymphoma: a population based analysis of epidemiological and health economic aspects in Germany.Annals of hematology · 2025Article
- CAR T-cell therapy in hematologic and solid malignancies: mechanisms, clinical applications, and future directions.Medical oncology (Northwood, London, England) · 2025Review
- Follicular lymphoma: contemporary clinical management with a focus on recent therapeutic advances.The Korean journal of internal medicine · 2025Review
- Effect of POD24 on the prognosis of follicular and other indolent B-cell non-hodgkin lymphomas.Annals of hematology · 2025Review
- Approved CAR-T therapies have reproducible efficacy and safety in clinical practice.Human vaccines & immunotherapeutics · 2024Review
- Optimizing Real-World Outcomes in High-Risk Relapsed/Refractory (r/r) FL with CAR-T Cell Therapy: A Vodcast and Case Example.Oncology and therapy · 2024Article
- Chimeric Antigen Receptor (CAR) T-Cell Therapy in Hematologic Malignancies: Clinical Implications and Limitations.Cancers · 2024Review
- CAR-T Cell Therapy for Follicular Lymphomas.Mediterranean journal of hematology and infectious diseases · 2024Review
- The treatment of follicular lymphoma with CD19-directed chimeric antigen receptor T-cell therapy.Frontiers in oncology · 2024Review
- Novel Bispecific T-Cell Engagers for the Treatment of Relapsed B Cell Non-Hodgkin Lymphomas: Current Knowledge and Treatment Considerations.Patient preference and adherence · 2024Review
- Comparison of the Efficacy and Safety of Axi-Cel and Tisa-Cel Based on Meta-Analysis.Journal of Cancer · 2024Article
- Gene targeted and immune therapies for nodal and gastrointestinal follicular lymphomas.World journal of gastroenterology · 2023Review
- Chimeric Antigen Receptor-T Cell Therapy for Lymphoma: New Settings and Future Directions.Cancers · 2023Review
- Enriching single-arm clinical trials with external controls: possibilities and pitfalls.Blood advances · 2023Article
- Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma.Journal of comparative effectiveness research · 2023Article
- Recent advances in treatment of nodal and gastrointestinal follicular lymphoma.World journal of gastroenterology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 14 institutions in 7 countries.
Funding
Abstract
The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory follicular lymphoma (r/r FL). As ELARA is a single-arm trial, this study compares tisa-cel outcomes from the ELARA trial with usual care from a real-world cohort. ELARA enrolled 98 patients as of 29 March 2021 (median follow-up: 15 months from enrollment). Usual care data were obtained from ReCORD-FL, a global retrospective study of patients with r/r FL, who met similar eligibility criteria to ELARA. With a data cutoff date of 31 December 2020, 187 patients with ≥2 preceding treatment lines were included in the ReCORD-FL (median follow-up: 57 months from third-line) study. An indirect treatment comparison was performed for 97 patients from the ELARA trial and 143 patients from the ReCORD-FL study with no missing data on baseline factors. The line of therapy for which outcomes were assessed was selected or matched between cohorts using propensity score modeling. After baseline factor adjustment via weighting by odds, complete response rate (CRR; 95% confidence interval) was 69.1% (59.8%-78.3%) for tisa-cel vs. 37.3% (26.4%-48.3%) for usual care; overall response rate was 85.6% (78.7%-92.5%) vs. 63.6% (52.5%-74.7%). Kaplan-Meier probability of being progression/event-free at 12 months was 70.5% (61.4%-79.7%) for tisa-cel vs. 51.9% (40.6%-63.3%) for usual care, with hazard ratio (HR)=0.60 (0.34-0.86); 12-month overall survival was 96.6% (92.9%-100%) vs. 71.7% (61.2%-82.2%), with HR=0.2 (0.02-0.38). In conclusion, tisa-cel was associated with a 1.9-fold higher complete response rate and a 1.4-fold higher rate of being progression or event free at 12 months vs usual care, as well as a death risk reduction of 80%. The findings provide additional evidence on the benefit of tisa-cel in patients with r/r FL after ≥2 treatment lines. This trial was registered at www.clinicaltrials.gov as NCT03568461.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.