What question did this study set out to answer?

To evaluate the safety, toxicity profile, and clinical efficacy of concurrent ibrutinib administration during CD19-targeted CAR-T cell therapy in patients with relapsed/refractory chronic lymphocytic leukemia.

June 1, 2019Hematological Oncology

Durable responses after CD19‐targeted CAR‐T cell immunotherapy with concurrent ibrutinib for CLL after prior ibrutinib failure

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Authors

JGJordan GauthierSeattle Cancer Care Alliance AHAlexandre V. HirayamaUniversity of Washington KHKevin A. HayOccupational Cancer Research Centre

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Implication

Clinical trial demonstrates durable responses and manageable toxicity with concurrent ibrutinib and CD19 CAR-T cells in relapsed chronic lymphocytic leukemia, indicating enhanced therapeutic efficacy.

Key Points

To evaluate the safety, toxicity profile, and clinical efficacy of concurrent ibrutinib administration during CD19-targeted CAR-T cell therapy in patients with relapsed/refractory chronic lymphocytic leukemia.
Conducted a pilot cohort within a phase I/II clinical trial (NCT01865617) in N=19 high-risk patients with relapsed/refractory CLL who had failed prior ibrutinib therapy.
Administered ibrutinib (420 mg/day) from ≥2 weeks pre-leukapheresis through ≥3 months post-infusion of 2x10⁵ or 2x10⁶/kg CD4+ and CD8+ CD19 CAR-T cells following lymphodepletion chemotherapy.
Among 18 evaluable patients, the overall response rate was 83% (CRi 22%, PR 61%), with 72% (13/18) achieving bone marrow clearance by flow cytometry and 61% (11/18) achieving MRD-negative marrow by IGH sequencing.
Cytokine release syndrome occurred in 74% of patients (grade 1: 32%, grade 2: 42%, no grade ≥3), while grade 3 neurotoxicity was observed in 26% (n=5).
In responders (n=15), 1-year overall survival was 80% (95% CI: 57–100%) and progression-free survival was 49% (95% CI: 23–100%); patients with IGH MRD-negative marrow reached 1-year OS of 100% and PFS of 62%.

Cite This Study

Gauthier et al. (2019) studied this question.

synapsesocial.com/papers/6a75fe4a1ce449dc42707e5c https://doi.org/10.1002/hon.126_2629

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Durable responses after CD19‐targeted CAR‐T cell immunotherapy with concurrent ibrutinib for CLL after prior ibrutinib failure

Discussion

Member takes

Implication

Key Points

Cite This Study

Durable responses after CD19‐targeted CAR‐T cell immunotherapy with concurrent ibrutinib for CLL after prior ibrutinib failure

Discussion

Member takes

Implication

Key Points

Cite This Study

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