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• W2952529424 abstract "Background: Pediatric patients with relapsed/refractory mature B-cell non-Hodgkin lymphoma (r/r B-NHL) have very poor prognosis and limited clinical benefit from available salvage therapies. Tisagenlecleucel is an anti-CD19 chimeric antigen receptor-T cell (CAR-T) therapy that was approved for the treatment of pediatric patients with r/r B-cell acute lymphoblastic leukemia in 2017 (Maude et al. NEJM. 2018) and adult patients with r/r diffuse large B-cell lymphoma (DLBCL) in 2018 (Schuster et al. NEJM. 2018) in the United States, and for the treatment of the same patient populations in 2018 in Europe. Very limited experience exists in collecting, producing, and treating pediatric B-NHL patients with CAR-T therapies. Here we introduce BIANCA (NCT03610724), a phase 2 trial investigating the safety and efficacy of tisagenlecleucel in pediatric patients with r/r B-NHL. This will be the first international multicenter trial to assess the feasibility and efficacy of an FDA/EMA-approved CAR-T cell therapy with centralized manufacturing in pediatric r/r NHL. Methods: BIANCA is a phase 2, single-arm, multicenter, open label trial of tisagenlecleucel in pediatric patients with CD19+ r/r B-NHL (including Burkitt lymphoma, DLBCL, primary mediastinal B-cell lymphoma, gray zone lymphoma, and follicular lymphoma). Eligible patients must be <18 years of age, weight ≥6 kg, and have confirmed B-NHL relapsed or refractory to ≥1 prior lines of therapy. Karnofsky (age ≥16 years) or Lansky (age <16 years) performance status must be ≥60. Patients must not have active central nervous system disease involvement before infusion or prior treatment with any anti-CD19 or gene therapy. Prior therapy can include systemic therapies and allogeneic or autologous hematopoietic stem cell transplant (HSCT) provided it occurred >3 months prior to screening. The primary endpoint of this study is overall response rate by International Pediatric NHL Response Criteria and Lugano 2014 criteria. Secondary outcomes include duration of response, event-free survival, relapse-free survival, progression-free survival, overall survival, pharmacokinetics, immunogenicity, frequency of post-tisagenlecleucel SCT, and biomarkers. Estimated enrollment for this study is 35 patients (at least 26 infused and evaluable). Clinical trial information: NCT03610724. Keywords: CD19; non-Hodgkin lymphoma (NHL). Disclosures: Burkhardt, B: Research Funding: Celgene, Roche. Maude, S: Honoraria: Novartis, Kite Pharamceuticals. Phillips, C: Honoraria: Novartis. Diaz de Heredia Rubio, C: Honoraria: Novartis. Laetsch, T: Consultant Advisory Role: Novartis, Loxo Oncology, Eli Lilly, Bayer; Research Funding: Novartis, Pfizer. Curran, K: Consultant Advisory Role: Novartis, Juno Therapeutics. Newsome, S: Employment Leadership Position: Novartis. Murray, N: Employment Leadership Position: Novartis. Pacaud, L: Employment Leadership Position: Novartis. Buechner, J: Honoraria: Novartis; Research Funding: Novartis." @default.
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• W2952529424 date "2019-06-01" @default.
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• W2952529424 title "BIANCA: A PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF TISAGENLECLEUCEL IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY MATURE B-CELL NON-HODGKIN LYMPHOMA" @default.
• W2952529424 doi "https://doi.org/10.1002/hon.5_2632" @default.
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