What question did this study set out to answer?

To evaluate the efficacy and toxicity of CD19-targeted CAR-T cell immunotherapy administered alone or in combination with concurrent ibrutinib for relapsed or refractory chronic lymphocytic leukemia.

January 31, 2019Biology of Blood and Marrow TransplantationOpen Access

Efficacy and Toxicity of CD19-Specific Chimeric Antigen Receptor T Cells Alone or in Combination with Ibrutinib for Relapsed and/or Refractory CLL

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Authors

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

Discussion

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Implication

Clinical trial demonstrates that concurrent ibrutinib enhances CD19 CAR-T cell responses and lowers severe toxicity in relapsed chronic lymphocytic leukemia, indicating a promising combination.

Key Points

To evaluate the efficacy and toxicity of CD19-targeted CAR-T cell immunotherapy administered alone or in combination with concurrent ibrutinib for relapsed or refractory chronic lymphocytic leukemia.
Phase 1/2 interventional trial (NCT01865617) evaluating cyclophosphamide and fludarabine lymphodepletion followed by 2 × 10^6 CD19 CAR-T cells/kg.
Compared outcomes between a prior cohort receiving CAR-T cells alone (No-Ibr, n=19) and a subsequent cohort receiving concurrent ibrutinib 420 mg/day from ≥2 weeks pre-leukapheresis through ≥3 months post-infusion (Ibr, n=17).
Overall response rates (complete and partial response) were 88% (14/16) in the Ibr cohort versus 56% (10/18) in the No-Ibr cohort (P = 0.06; multivariable OR = 14.02, P = 0.05).
Grade ≥3 cytokine release syndrome occurred in 0% (0/17) of the Ibr cohort compared to 26% (5/19) of the No-Ibr cohort (P = 0.05), accompanied by significantly lower peak serum levels of IL-8 (P = 0.04), IL-15 (P = 0.003), and MCP-1 (P = 0.004).
Among patients with no detectable disease by bone marrow flow cytometry, 83% (10/12) in the Ibr cohort versus 60% (6/10) in the No-Ibr cohort lacked malignant IgH sequences at 4 weeks (P = 0.35).

Cite This Study

Gauthier et al. (2019) studied this question.

synapsesocial.com/papers/6aaa12ef3e26af5d367e5f0f https://doi.org/10.1016/j.bbmt.2018.12.074

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Implication

Clinical trial demonstrates that concurrent ibrutinib enhances CD19 CAR-T cell responses and lowers severe toxicity in relapsed chronic lymphocytic leukemia, indicating a promising combination.

Efficacy and Toxicity of CD19-Specific Chimeric Antigen Receptor T Cells Alone or in Combination with Ibrutinib for Relapsed and/or Refractory CLL

Discussion

Member takes

Implication

Key Points

Cite This Study

Efficacy and Toxicity of CD19-Specific Chimeric Antigen Receptor T Cells Alone or in Combination with Ibrutinib for Relapsed and/or Refractory CLL

Discussion

Member takes

Implication

Key Points

Cite This Study

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