Jay Yaakov Spiegel

All Publications

• Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Nastoupil, L. J., Jain, M. D., Feng, L., Spiegel, J. Y., Ghobadi, A., Lin, Y., Dahiya, S., Lunning, M., Lekakis, L., Reagan, P., Oluwole, O., McGuirk, J., Deol, A., Sehgal, A. R., Goy, A., Hill, B. T., Vu, K., Andreadis, C., Munoz, J., Westin, J., Chavez, J. C., Cashen, A., Bennani, N. N., Rapoport, A. P., Vose, J. M., Miklos, D. B., Neelapu, S. S., Locke, F. L. 2020: JCO1902104

  Abstract

  PURPOSE: Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and complete response rates in infused patients of 83% and 58%, respectively. We report clinical outcomes with axi-cel in the standard-of-care (SOC) setting for the approved indication.PATIENTS AND METHODS: Data were collected retrospectively from all patients with relapsed/refractory LBCL who underwent leukapheresis as of September 30, 2018, at 17 US institutions with the intent to receive SOC axi-cel. Toxicities were graded and managed according to each institution's guidelines. Responses were assessed as per Lugano 2014 classification.RESULTS: Of 298 patients who underwent leukapheresis, 275 (92%) received axi-cel therapy. Compared with the registrational ZUMA-1 trial, 129 patients (43%) in this SOC study would not have met ZUMA-1 eligibility criteria because of comorbidities at the time of leukapheresis. Among the axi-cel-treated patients, grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 7% and 31%, respectively. Nonrelapse mortality was 4.4%. Best overall and complete response rates in infused patients were 82% (95% CI, 77% to 86%) and 64% (95% CI, 58% to 69%), respectively. At a median follow-up of 12.9 months from the time of CAR T-cell infusion, median progression-free survival was 8.3 months (95% CI, 6.0 to15.1 months), and median overall survival was not reached. Patients with poor Eastern Cooperative Oncology Group performance status of 2-4 and elevated lactate dehydrogenase had shorter progression-free and overall survival on univariable and multivariable analysis.CONCLUSION: The safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial.

  View details for DOI 10.1200/JCO.19.02104

  View details for PubMedID 32401634

• Outcomes Following Failure of JAK 1/2 Inhibitor Therapy in Patients with Myelofibrosis is Dependent on the Pattern of Failure McNamara, C., Spiegel, J., Xu, W., Kennedy, J., Arruda, A., Yu, M., Claudio, J., Malik, S., Siddiq, N., Cheung, V., Tierens, A., Maze, D., Sibai, H., Gupta, V. CIG MEDIA GROUP, LP. 2019: S351–S352

  View details for DOI 10.1016/j.clml.2019.07.366

  View details for Web of Science ID 000483480700397

• Monitoring ctDNA in r/r DLBCL patients following the CAR T-cell therapy axicabtagene ciloleucel: Day 28 landmark analysis. Frank, M., Hossain, N. M., Bukhari, A., Dean, E., Spiegel, J. Y., Claire, G. K., Kirsch, I., Jacob, A., Mullins, C. D., Lee, L., Kong, K. A., Craig, J. K., Mackall, C., Rapoport, A., Dahiya, S., Locke, F., Miklos, D. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for Web of Science ID 000487345806314

• Utilization of value stream mapping to improve chimeric antigen receptor (CAR) T-cell patient experience at an academic medical center (AMC). Porter, J., Kong, K. A., Latchford, T., Bergman, D., Doran, S., Fajardo, N., Goldstein, G., Rodin, M., Smith, A., Spiegel, J. Y., Miklos, D. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for DOI 10.1200/JCO.2019.37.15_suppl.6607

  View details for Web of Science ID 000487345806161

• Outcomes in large B-cell lymphoma progressing after axicabtagene ciloleucel (Axi-cel): Results from the US Lymphoma CAR-T Consortium. Spiegel, J. Y., Dahiya, S., Jain, M. D., Nastoupil, L. J., Ghobadi, A., Lin, Y., Lunning, M., Reagan, P., McGuirk, J., Deol, A., Munoz, J., Locke, F., Neelapu, S., Tamaresis, J. S., Rapoport, A., Miklos, D., Hill, B. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for Web of Science ID 000487345806279

• Elevated Axicabtagene Ciloleucel (CAR-19) Expansion By Immunophenotyping Is Associated with Toxicity in Diffuse Large B-Cell Lymphoma Spiegel, J. Y., Sahaf, B., Hossain, N., Frank, M. J., Claire, G., Abramian, M., Latchford, T., Villa, B., Cancilla, J., Oak, J., Natkunam, Y., Long, S. R., Arai, S., Johnston, L. J., Lowsky, R., Meyer, E. H., Muffly, L. S., Negrin, R. S., Rezvani, A. R., Shizuru, J. A., Weng, W., Kong, K. A., Mackall, C. L., Miklos, D. B. AMER SOC HEMATOLOGY. 2018

  View details for DOI 10.1182/blood-2018-99-113261

  View details for Web of Science ID 000454837601285

• Target Antigen Downregulation and Other Mechanisms of Failure after Axicabtagene Ciloleucel (CAR19) Therapy Oak, J., Spiegel, J. Y., Sahaf, B., Natkunam, Y., Long, S. R., Hossain, N., Mackall, C. L., Kong, K. A., Miklos, D. B. AMER SOC HEMATOLOGY. 2018

  View details for DOI 10.1182/blood-2018-99-120206

  View details for Web of Science ID 000454842804282

• Phase I Experience with a Bi-Specific CAR Targeting CD19 and CD22 in Adults with B-Cell Malignancies Hossain, N., Sahaf, B., Abramian, M., Spiegel, J. Y., Kong, K., Kim, S., Mavroukakis, S., Oak, J., Natkunam, Y., Meyer, E. H., Frank, M. J., Feldman, S. A., Long, S. R., Qin, H., Fry, T. J., Muffly, L. S., Mackall, C. L., Miklos, D. B. AMER SOC HEMATOLOGY. 2018

  View details for DOI 10.1182/blood-2018-99-110142

  View details for Web of Science ID 000454837601199

• Axicabtagene Ciloleucel (Axi-cel) CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma: Real World Experience Nastoupil, L. J., Jain, M. D., Spiegel, J. Y., Ghobadi, A., Lin, Y., Dahiya, S., Lunning, M. A., Lekakis, L. J., Reagan, P. M., Oluwole, O. O., McGuirk, J. P., Deol, A., Sehgal, A. R., Goy, A., Hill, B. T., Andreadis, C., Munoz, J., Westin, J. R., Chavez, J. C., Cashen, A. F., Bennani, N. N., Rapoport, A. P., Vose, J. M., Miklos, D. B., Neelapu, S. S., Locke, F. L. AMER SOC HEMATOLOGY. 2018

  View details for DOI 10.1182/blood-2018-99-114152

  View details for Web of Science ID 000454837600145