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<p>The pivotal trials of axicabtagene ciloleucel (axi-cel) chimeric Antigen receptor (CAR-T) therapy and other CD19 CAR-Ts were mainly done in the inpatient setting. We conducted a single-center non-randomized open label prospective clinical trial (NCT05108805). Objective was to evaluate the feasibility and safety of outpatient administration of axi-cel for relapsed/refractory diffuse B cell lymphoma (R/R DLBCL) using continuous remote patient monitoring with wearable devices and telemedicine. We enrolled 25 and treated 20 patients on this clinical trial from November 2021 to October 2023. The median follow up was 374 days (95% CI: 364–484). The median age was 69 years and 18 of 20 patients (90%) received prophylactic corticosteroids. Nineteen patients got admitted for management of cytokine release syndrome (CRS) in the first 4 weeks. The median duration of hospital stay was 5.5 days (range: 0–21). Two patients required ICU stay due to pre-existing conditions exacerbated by CRS. Grade 2 CRS was seen in 40% and no pt had grade ≥3 CRS. Grade 3 Immune effector cell-associated neurotoxicity syndrome (ICANS) was seen in 20% and none had grade ≥4 ICANS. No treatment-related death by last follow-up. The results of our pilot study confirm the feasibility of outpatient administration of axi-cel.</p>

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Feasibility of axicabtagene ciloleucel in the outpatient setting: primary analysis of prospective trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月24日

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  • Bhagirathbhai Dholaria,
  • Shakthi T. Bhaskar,
  • Vivek G. Patel,
  • Eden Biltibo,
  • Reena Jayani,
  • Salyka Sengsayadeth,
  • Andrew Jallouk,
  • James Jerkins,
  • Brittney Baer,
  • Ali Nur,
  • Muhamed Baljevic,
  • Bipin N. Savani,
  • David Morgan,
  • Adetola A. Kassim,
  • Olalekan O. Oluwole

摘要

The pivotal trials of axicabtagene ciloleucel (axi-cel) chimeric Antigen receptor (CAR-T) therapy and other CD19 CAR-Ts were mainly done in the inpatient setting. We conducted a single-center non-randomized open label prospective clinical trial (NCT05108805). Objective was to evaluate the feasibility and safety of outpatient administration of axi-cel for relapsed/refractory diffuse B cell lymphoma (R/R DLBCL) using continuous remote patient monitoring with wearable devices and telemedicine. We enrolled 25 and treated 20 patients on this clinical trial from November 2021 to October 2023. The median follow up was 374 days (95% CI: 364–484). The median age was 69 years and 18 of 20 patients (90%) received prophylactic corticosteroids. Nineteen patients got admitted for management of cytokine release syndrome (CRS) in the first 4 weeks. The median duration of hospital stay was 5.5 days (range: 0–21). Two patients required ICU stay due to pre-existing conditions exacerbated by CRS. Grade 2 CRS was seen in 40% and no pt had grade ≥3 CRS. Grade 3 Immune effector cell-associated neurotoxicity syndrome (ICANS) was seen in 20% and none had grade ≥4 ICANS. No treatment-related death by last follow-up. The results of our pilot study confirm the feasibility of outpatient administration of axi-cel.