Evidence map›Paper›PMID 36404384›Full record

Trial reportInternational journal of hematology2023

Efficacy and safety of tisagenlecleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: results from the phase 2 ELARA trial.

Noriko Fukuhara, Koji Kato, Hideki Goto, Tajima Takeshi, Mayu Kawaguchi, Kota Tokushige, Koichi Akashi, Takanori Teshima, Hideo Harigae, Stephen J Schuster and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2023. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT03568461 phase2completednot on this map

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

TypeinterventionalSponsorNovartis PharmaceuticalsRan2018 to 2025Enrolled98ConditionsFollicular LymphomaArmstisagenlecleucel
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Noriko FukuharaDepartment of Hematology, Tohoku University Hospital, 1-1 Seiryo-cho, Sendai, 980-8574, Japan. nfukuhara@med.tohoku.ac.jp.ORCID http://orcid.org/0000-0003-2682-2179
Koji KatoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Hideki GotoDepartment of Hematology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Tajima TakeshiNovartis Pharma K.K, Toranomon Minato-ku, Tokyo, Japan.
Mayu KawaguchiNovartis Pharma K.K, Toranomon Minato-ku, Tokyo, Japan.
Kota TokushigeNovartis Pharma K.K, Toranomon Minato-ku, Tokyo, Japan.
Koichi AkashiDepartment of Hematology, Tohoku University Hospital, 1-1 Seiryo-cho, Sendai, 980-8574, Japan.
Takanori TeshimaDepartment of Hematology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hideo HarigaeDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Stephen J SchusterLymphoma Program, University of Pennsylvania, Philadelphia, PA, USA.
Catherine ThieblemontAPHP, Hôpital Saint-Louis-Université de Paris, Paris, France.
Martin DreylingDepartment of Internal Medicine III, LMU Hospital, Munich, Germany.
Nathan FowlerThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTisagenlecleucel yielded a high durable response rate in patients with relapsed/refractory (r/r) follicular lymphoma (FL) in the global phase 2 ELARA trial. Here, we report the efficacy, safety, and cellular kinetics of tisagenlecleucel in a subgroup of Japanese patients with r/r FL from ELARA.

methodsELARA (NCT03568461) is a global single-arm trial of tisagenlecleucel in patients with r/r FL who received ≥ 2 prior lines of therapy. The primary endpoint was the complete response rate (CRR), and the secondary endpoints were the overall response rate, duration of response, progression-free survival, overall survival, safety, and cellular kinetics.

resultsAs of March 29, 2021, nine Japanese patients were enrolled and received tisagenlecleucel with a median follow-up of 13.6 months (range, 10.5‒19.3). Per independent review committee, CRR was 100% (95% CI 63.1‒100). Within 8 weeks of infusion, cytokine release syndrome (CRS) of any grade was reported in 6 patients (66.7%); however, no grade ≥ 3 CRS or any grade serious neurological events or treatment-related deaths were observed.

conclusionTisagenlecleucel showed high efficacy and manageable safety in adult Japanese patients with r/r FL. Moreover, the clinical outcomes were similar to the global population, which supports the potential of tisagenlecleucel in Japanese patients with r/r FL.

Indexed as

Lymphoma, FollicularAdultEast Asian PeopleHumansImmunotherapy, AdoptiveProgression-Free SurvivalReceptors, Antigen, T-CellReceptors, Antigen, T-CelltisagenlecleucelCAR-TELARARelapsed or refractory follicular lymphomaTisagenlecleucel

Identifiers

PMID36404384
PMCPMC9889457

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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.