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Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor T cell therapy that has shown clinically significant results in patients with relapsed/refractory B-cell lymphoma
.
The FDA released the first chimeric antigen receptor (CAR) T cell therapy, authorizing the use of Tisagenlecleucel to treat patients with B-cell precursor acute lymphoblastic leukemia (ALL) under the age of 25.
In the past, Tisagenlecleucel was used to treat relapsed/refractory Tisagenlecleucel.
Recently, a research article was published in the top medical journal Nature Medicine.
In this study, researchers reported a preliminary, pre-specified interim analysis of Tisagenlecleucel's ELARA Phase 2 multi-country trial
.
The trial was conducted in relapsed/refractory FL adults (No.
NCT03568461) who had relapsed after receiving two or more courses of treatment or required autologous stem cell transplantation.
As of March 29, 2021, 97/98 patients enrolled in the study received Tisagenlecleucel treatment (median follow-up time was 16.
59 months; interquartile range was 13.
8-20.
21) and reached the primary endpoint of the study
.
In the efficacy group (n=94), CRR was 69.
1% (95% confidence interval was 58.
In the safety group (n=97), within 8 weeks of Tisagenlecleucel infusion, the incidence of cytokine release syndrome was 48.
5% (grade ≥ 3, 0%), and the neurological event was 37.
1% (grade ≥ 3, 3).
%) and immune effector cell-related neurotoxicity syndrome (ICANS) was 4.
1% (grade ≥3, 1%)
.
There were no treatment-related deaths
.
Thus, Tisagenlecleucel is safe and effective for relapsed/refractory FL patients with extensive pretreatment, including high-risk patients
.
.
Original source:
Original source:Nathan Hale Fowler,et al.
Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.
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