Feasibility of outpatient administration of axicabtagene ciloleucel and brexucabtagene autoleucel using telemedicine tools: The Vanderbilt experience

Dholaria, Bhagirathbhai; Mehraban, Nasima; Baer, Brittney; Long, Nancy; Jayani, Reena; Byrne, Michael; Kassim, Adetola A.; Engelhardt, Brian G.; Savani, Bipin N.; Oluwole, Olalekan O.

doi:10.1111/bjh.18339

Cited by 15 publications

(11 citation statements)

References 12 publications

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“…6 Experience in administering axi-cel outpatient is limited due to high rates of CRS and ICANS associated with CAR T-cell constructs with a CD28 costimulatory domain. 26 To our knowledge, our cohort of 18 patients who underwent treatment and monitoring outpatient following axi-cel administration is the largest published to date. We did not observe higher incidence of all-grade and ≥G3 toxicities with outpatient compared with inpatient axi-cel infusion.…”

Section: Discussionmentioning

confidence: 99%

Bendamustine lymphodepletion is a well‐tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B‐cell lymphoma

Ong,

Pak,

Mei

et al. 2023

American J Hematol

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Fludarabine/cyclophosphamide (Flu/Cy) is established for lymphodepletion (LD) prior to standard‐of‐care CAR T‐cell therapy for lymphoma. There is ongoing need to test alternative LD regimens to preserve efficacy, improve safety, and address challenges including the recent national fludarabine shortage. We retrospectively evaluated outcomes among patients with relapsed/refractory aggressive B‐cell lymphoma who received bendamustine (n = 27) or Flu/Cy (n = 42) LD before axicabtagene ciloleucel (axi‐cel) at our institution. The median change in absolute lymphocyte count from pre‐LD to time of axi‐cel infusion was −0.6×109/L in bendamustine cohort and −0.7×109/L in Flu/Cy cohort. The best overall response/complete response rates were 77.8% (95% CI: 57.7%–91.4%)/48.1% (95% CI: 28.7%–68.1%) among bendamustine cohort and 81.0% (95% CI: 65.9%–91.4%)/50.0% (95% CI: 34.2%–65.8%) among Flu/Cy cohort. Six‐month progression‐free survival were 43.8% (95% CI: 24.7%–61.3%) and 55.6% (95% CI: 39.0%–69.3%) in bendamustine and Flu/Cy cohorts, while 6‐month overall survival were 81.5% (95% CI: 61.1%–91.8%) and 90.4% (95% CI: 76.4%–96.3%), respectively. Relative to Flu/Cy‐treated patients, bendamustine‐treated patients did not show an increase in hazards associated with experiencing progression/relapse/death (aHR:1.4 [95% CI: 0.7–2.8]; p = .32) or death (aHR:1.6 [95% CI: 0.5–5.6]; p = .46), after adjusting for baseline number of prior therapies and refractory disease. Any grade/grade ≥3 CRS were observed in 89%/3.7% and 86%/4.8% among bendamustine and Flu/Cy cohorts, while any grade ICANS/grade ≥3 ICANS were observed in 30%/19% and 55%/31% respectively. While more Flu/Cy‐treated patients experienced grade ≥3 neutropenia compared with bendamustine‐treated patients (100% vs. 68%), grade ≥3 infectious complications were comparable (24% vs. 19% respectively). More patients received bendamustine LD and axi‐cel as outpatient than Flu/Cy cohort, without increased toxicities and with shorter median inpatient stays. In conclusion, we observed comparable efficacy and lower any grade ICANS among patients receiving bendamustine relative to Flu/Cy LD, followed by axi‐cel.

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Section: Discussionmentioning

confidence: 99%

Bendamustine lymphodepletion is a well‐tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B‐cell lymphoma

Ong,

Pak,

Mei

et al. 2023

American J Hematol

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“…Axi-cel and brexu-cel have some of the highest response rates but carry higher risks of CRS and ICANS. Dholaria and colleagues reported a series of 13 patients treated with axi-cel and brexu-cel (LBCL, n=9; MCL, n=4) in the outpatient setting ( 15 ). Relevant staff and caregiver training was implemented, as well as telemedicine visits for remote outpatient monitoring.…”

Section: Cd19 Targeted Car T-cell Therapy For B-cell Malignanciesmentioning

confidence: 99%

Outpatient administration of CAR T-cell therapy: a focused review with recommendations for implementation in community based centers

Perez,

Al Sagheer,

Nahas

et al. 2024

Front. Immunol.

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Chimeric Antigen Receptor T-cell (CAR-T) therapy has transformed the treatment landscape for hematological malignancies, showing high efficacy in patients with relapsed or refractory (R/R) disease and otherwise poor prognosis in the pre-CAR-T era. These therapies have been usually administered in the inpatient setting due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). However, there is a growing interest in the transition to outpatient administration due to multiple reasons. We review available evidence regarding safety and feasibility of outpatient administration of CD19 targeted and BCMA targeted CAR T-cell therapy with an emphasis on the implementation of outpatient CAR-T programs in community-based centers.

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“…indicate that patients receiving any CAR-T can be managed in the outpatient setting with adequate resourcing and technology support (eg, telehealth and remote patient monitoring; Fig 1). 58,59 Although all CAR-T approved by the FDA till date have been classified as drugs, they are ultimately cellular therapy products and their administration is restricted to treatment centers with expertise, resources, and quality infrastructure similar to HCT, such as the Foundation for the Accreditation of Cellular Therapy accreditation. Analogous to HCT, close coordination of a patient's treating hematologist-oncologist with a CAR-T center and early referral is critical to optimizing access and outcomes.…”

Section: Access Referral and Care Coordination With Car-t Centermentioning

confidence: 99%

Section: Access Referral and Care Coordination With Car-t Centermentioning

confidence: 99%

Chimeric Antigen Receptor T-Cell Therapy for Hematologic Malignancies: A Practical Review

Gregory

Majhail

Jain

2023

JCO Oncology Practice

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Chimeric antigen receptor T-cell (CAR-T) therapy has become an established therapeutic approach for the treatment of hematologic malignancies. The field continues to evolve rapidly and newer-generation constructs are being designed to enhance proliferative capacity, and achieve long-term persistence and greater efficacy with an overall lower incidence of toxicity. Initial clinical application of CAR-T therapies has focused on relapsed and/or refractory hematologic malignancies, and Food and Drug Administration–approved CAR-T products targeting CD19 are available for B-cell acute lymphoblastic leukemia and low- and high-grade B-cell non-Hodgkin lymphoma, and targeting B-cell maturation antigen are available for multiple myeloma. Cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome have been recognized as class specific toxicities associated with these novel therapies. In this review, we focus on the clinical application of CAR-T therapies in adult patients with hematologic malignancies, including access issues, outpatient administration, and appropriate timing for referring a patient to a CAR-T treatment center.

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Feasibility of outpatient administration of axicabtagene ciloleucel and brexucabtagene autoleucel using telemedicine tools: The Vanderbilt experience

Cited by 15 publications

References 12 publications

Bendamustine lymphodepletion is a well‐tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B‐cell lymphoma

Bendamustine lymphodepletion is a well‐tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B‐cell lymphoma

Outpatient administration of CAR T-cell therapy: a focused review with recommendations for implementation in community based centers

Chimeric Antigen Receptor T-Cell Therapy for Hematologic Malignancies: A Practical Review

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