Browsing by Author "Kochenderfer, James N."

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    Screening Clinical Cell Products for Replication Competent Retrovirus: The National Gene Vector Biorepository Experience
    (Elsevier, 2018-09-21) Cornetta, Kenneth; Duffy, Lisa; Feldman, Steven A.; Mackall, Crystal L.; Davila, Marco L.; Curran, Kevin J.; Junghans, Richard P.; Tang, Jean Yuh; Kochenderfer, James N.; O'Cearbhaill, Roisin; Archer, Gary; Kiem, Hans-Peter; Shah, Nirali N.; Delbrook, Cindy; Kaplan, Rosie; Brentjens, Renier J.; Rivière, Isabelle; Sadelain, Michel; Rosenberg, Steven A.; Medical and Molecular Genetics, School of Medicine
    Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, we reviewed 286 control (n = 4) and transduced cell products (n = 282) screened for RCR in the National Gene Vector Biorepository. The transduced cell samples were submitted from 14 clinical trials. All vector products were previously shown to be negative for RCR prior to use in cell transduction. After transduction, all 282 transduced cell products were negative for RCR. In addition, 241 of the clinical trial participants were also screened for RCR by analyzing peripheral blood at least 1 month after infusion, all of which were also negative for evidence of RCR infection. The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value.
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    The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of hematologic malignancies: multiple myeloma, lymphoma, and acute leukemia
    (BioMed Central, 2016-12-20) Boyiadzis, Michael; Bishop, Michael R.; Abonour, Rafat; Anderson, Kenneth C.; Ansell, Stephen M.; Avigan, David; Barbarotta, Lisa; Barrett, Austin John; Van Besien, Koen; Bergsagel, Leif; Borrello, Ivan; Brody, Joshua; Brufsky, Jill; Cairo, Mitchell; Chari, Ajai; Cohen, Adam; Cortes, Jorge; Forman, Stephen J.; Friedberg, Jonathan W.; Fuchs, Ephraim J.; Gore, Steven D.; Jagannath, Sundar; Kahl, Brad S; Kline, Justin; Kochenderfer, James N.; Kwak, Larry W.; Levy, Ronald; de Lima, Marcos; Litzow, Mark R.; Mahindra, Anuj; Miller, Jeffrey; Munshi, Nikhil C.; Orlowski, Robert Z.; Pagel, John M.; Porter, David L.; Russell, Stephen J.; Schwartz, Karl; Shipp, Margaret A.; Siegel, David; Stone, Richard M.; Tallman, Martin S.; Timmerman, John M.; Van Rhee, Frits; Waller, Edmund K.; Welsh, Ann; Werner, Michael; Wiernik, Peter H.; Dhodapkar, Madhav V.; Department of Medicine, IU School of Medicine
    Increasing knowledge concerning the biology of hematologic malignancies as well as the role of the immune system in the control of these diseases has led to the development and approval of immunotherapies that are resulting in impressive clinical responses. Therefore, the Society for Immunotherapy of Cancer (SITC) convened a hematologic malignancy Cancer Immunotherapy Guidelines panel consisting of physicians, nurses, patient advocates, and patients to develop consensus recommendations for the clinical application of immunotherapy for patients with multiple myeloma, lymphoma, and acute leukemia. These recommendations were developed following the previously established process based on the Institute of Medicine’s clinical practice guidelines. In doing so, a systematic literature search was performed for high-impact studies from 2004 to 2014 and was supplemented with further literature as identified by the panel. The consensus panel met in December of 2014 with the goal to generate consensus recommendations for the clinical use of immunotherapy in patients with hematologic malignancies. During this meeting, consensus panel voting along with discussion were used to rate and review the strength of the supporting evidence from the literature search. These consensus recommendations focus on issues related to patient selection, toxicity management, clinical endpoints, and the sequencing or combination of therapies. Overall, immunotherapy is rapidly emerging as an effective therapeutic strategy for the management of hematologic malignances. Evidence-based consensus recommendations for its clinical application are provided and will be updated as the field evolves.