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201. Biomarker Profiling Differentiates Sepsis from Cytokine Release Syndrome in Chimeric Antigen Receptor T-Cell Therapy for Acute Lymphoblastic Leukemia (ALL)

Author

Lacey, Simon F., primary, Shaw, Pamela A, additional, Teachey, David T, additional, Weiss, Scott L., additional, Chen, Fang, additional, Gonzalez, Vanessa E, additional, Frey, Noelle, additional, Porter, David L, additional, Maude, Shannon L, additional, Grupp, Stephan A, additional, Pequignot, Edward, additional, June, Carl H, additional, and Melenhorst, Jan J., additional

Published
2016
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202. Allogeneic Stem Cell Transplantation in Patients ≥70 Years Old

Author

Walling, Christopher C, primary, Shaw, Pamela A, additional, Frey, Noelle V, additional, Gill, Saar I, additional, Hexner, Elizabeth O., additional, Loren, Alison W, additional, Luger, Selina, additional, Mangan, James K, additional, Martin, Mary Ellen, additional, Smith, Jacqueline, additional, Stadtmauer, Edward A., additional, and Porter, David L., additional

Published
2016
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204. Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CTL019) in Conjunction with Salvage Autologous Stem Cell Transplantation for Advanced Multiple Myeloma

Author

Garfall, Alfred L., primary, Stadtmauer, Edward A, additional, Maus, Marcela V., additional, Hwang, Wei-Ting, additional, Vogl, Dan T., additional, Cohen, Adam D., additional, Weiss, Brendan M, additional, Porter, David L, additional, Frey, Noelle, additional, Milone, Michael, additional, Mangan, Patricia, additional, Krevvata, Maria, additional, Ayers, Emily, additional, Dengel, Karen, additional, Kerr, Naseem DS, additional, Lacey, Simon F., additional, Melenhorst, Jan Joseph, additional, Ambrose, David E, additional, Chen, Fang, additional, Gonzalez, Vanessa E, additional, Kulikovskaya, Irina, additional, Gupta, Minnal, additional, Finklestein, Jeffrey, additional, Lamontagne, Anne, additional, O'Rourke, Matthew, additional, Suhoski Davis, Megan, additional, Malykhin, Alexander, additional, Levine, Bruce L, additional, and June, Carl H, additional

Published
2016
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205. Cellular Kinetics of Chimeric Antigen Receptor T Cells (CTL019) in Patients with Relapsed/Refractory CD19+ Leukemia

Author

Mueller, Karen Thudium, primary, Chakraborty, Abhijit, additional, Wood, Patricia A, additional, Awasthi, Rakesh, additional, Quintas-Cardama, Alfonso, additional, Han, Xia, additional, Maude, Shannon L, additional, Grupp, Stephan A., additional, Porter, David L, additional, Frey, Noelle, additional, Marcucci, Katherine T., additional, Levine, Bruce L, additional, Melenhorst, Jan J., additional, June, Carl H, additional, and Lacey, Simon F., additional

Published
2016
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206. Oral Vancomycin Prophylaxis Is Highly Effective in Preventing Clostridium difficile Infection in Allogeneic Hematopoietic Cell Transplant Recipients.

Author

Ganetsky, Alex, Han, Jennifer H, Hughes, Mitchell E, Babushok, Daria V, Frey, Noelle V, Gill, Saar I, Hexner, Elizabeth O, Loren, Alison W, Luger, Selina M, Mangan, James K, Martin, Mary Ellen, Smith, Jacqueline, Freyer, Craig W, Gilmar, Cheryl, Schuster, Mindy, Stadtmauer, Edward A, and Porter, David L

Subjects
CLOSTRIDIUM diseases, DISEASE relapse, CONFIDENCE intervals, GASTROINTESTINAL diseases, GRAFT versus host disease, HEMATOPOIETIC stem cell transplantation, HOSPITAL admission & discharge, ORAL drug administration, PATIENTS, POSTOPERATIVE period, TRANSPLANTATION of organs, tissues, etc., VANCOMYCIN, DISCHARGE planning, TREATMENT effectiveness, DISEASE incidence, RETROSPECTIVE studies, ANTIBIOTIC prophylaxis, ODDS ratio, DISEASE risk factors, DIAGNOSIS, PREVENTION
Abstract

Background Clostridium difficile infection (CDI) is a leading cause of infectious complications in allogeneic hematopoietic cell transplant recipients (alloHCT). We sought to evaluate whether prophylactic oral vancomycin reduces the incidence of CDI in alloHCT recipients. Methods We conducted a retrospective cohort study to examine the effectiveness of CDI prophylaxis with oral vancomycin, as compared to no prophylaxis, in 145 consecutive adult alloHCT recipients at the University of Pennsylvania between April 2015 and November 2016. Patients received oral vancomycin 125 mg twice daily, starting on admission and continuing until discharge. The primary outcome of interest was the association between oral vancomycin prophylaxis and CDI diagnosis. Secondary outcomes included graft-versus-host disease (GVHD) and relapse. Results There were no cases of CDI in patients that received prophylaxis (0/90, 0%), whereas 11/55 (20%) patients who did not receive prophylaxis developed CDI (P <.001). Oral vancomycin prophylaxis was not associated with a higher risk of acute, grades 2–4 GVHD (subhazard ratio [sHR] 1.59; 95% confidence interval [CI] 0.88–2.89; P =.12), acute, grades 3–4 GVHD (sHR 0.65; 95% CI 0.25–1.66; P =.36), or acute, grades 2–4 gastrointestinal GVHD (sHR 1.95; 95% CI 0.93–4.07; P =.08) at day 180 post-transplant. No associations between oral vancomycin and relapse or survival were observed. Conclusions Prophylaxis with oral vancomycin is highly effective in preventing CDI in alloHCT recipients without increasing the risk of graft-versus-host disease or disease relapse. Further evaluation via a prospective study is warranted. [ABSTRACT FROM AUTHOR]

Published
2019
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207. Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation.

Author

Kansagra, Ankit J., Frey, Noelle V., Bar, Merav, Laetsch, Theodore W., Carpenter, Paul A., Savani, Bipin N., Heslop, Helen E., Bollard, Catherine M., Komanduri, Krishna V., Gastineau, Dennis A., Chabannon, Christian, Perales, Miguel A., Hudecek, Michael, Aljurf, Mahmoud, Andritsos, Leslie, Barrett, John A., Bachanova, Veronika, Bonini, Chiara, Ghobadi, Armin, and Gill, Saar I.

Subjects
*T cell receptors, *CHIMERIC antigen receptors, *B cell receptors, *LYMPHOBLASTIC leukemia, *B cells, *ACUTE leukemia
Abstract

Abstract On August 30, 2017 the US Food and Drug Administration approved tisagenlecleucel (Kymriah; Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present, ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring, and disease assessments. To address these issues experts representing the American Society for Blood and Marrow Transplant, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved. [ABSTRACT FROM AUTHOR]

Published
2019
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208. Impact of prior inotuzumab ozogamicin treatment on brexucabtagene autoleucel outcomes in adults with B-cell ALL

Author

Aldoss, Ibrahim, Roloff, Gregory W., Faramand, Rawan, Kopmar, Noam E., Lin, Chenyu, Advani, Anjali S., Dekker, Simone E., Gupta, Vishal K., O'Connor, Timothy E., Jeyakumar, Nikeshan, Muhsen, Ibrahim N., Valtis, Yannis, Zhang, Amy, Miller, Katharine, Sutherland, Katherine, Dykes, Kaitlyn C., Ahmed, Mohamed, Chen, Evan, Zambrano, Hector, Bradshaw, Danielle, Mercadal, Santiago, Schwartz, Marc, Tracy, Sean, Dholaria, Bhagirathbhai, Kubiak, Michal, Mukherjee, Akash, Majhail, Navneet, Battiwalla, Minoo, Mountjoy, Luke, Malik, Shahbaz A., Mathews, John, Shaughnessy, Paul, Logan, Aaron C., Ladha, Abdullah, Stefan, Maryann, Guzowski, Caitlin, Hoeg, Rasmus T., Hilal, Talal, Moore, Jozal, Connor, Matthew, O'Dwyer, Kristen M., Hill, LaQuisa C., Tsai, Stephanie B., Sasine, Joshua, Solh, Melhem M., Lee, Catherine J., Kota, Vamsi K., Koura, Divya, Veeraputhiran, Muthu, Blunk, Betsy, Oliai, Caspian, Leonard, Jessica T., Frey, Noelle V., Park, Jae H., Luskin, Marlise R., Bachanova, Veronika, Galal, Ahmed, Bishop, Michael R., Stock, Wendy, Cassaday, Ryan D., Pullarkat, Vinod, Shah, Bijal D., and Muffly, Lori S.

Abstract

•InO-exposed patients with r/r B-ALL have inferior outcomes after brexu-cel, particularly those who were nonresponders to InO.•The negative association is unrelated directly to InO per se; rather, it reflects selection of patients with intrinsically adverse-risk ALL.

Published
2024
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209. Bendamustine as Lymphodepletion for Brexucabtagene Autoleucel Therapy of Mantle Cell Lymphoma

Author

Chong, Elise A., Chong, Emeline R., Therwhanger, Dylan, Nasta, Sunita D., Landsburg, Daniel J., Barta, Stefan K., Svoboda, Jakub, Gerson, James N., Ghilardi, Guido, Paruzzo, Luca, Fraietta, Joseph A., Weber, Elizabeth, Stefano, Natalie, Porter, David L., Frey, Noelle V., Garfall, Alfred L., Ruella, Marco, and Schuster, Stephen J.

Abstract

•Bendamustine lymphodepletion is a safe and effective alternative prior to brexu-cel.•CAR T cell expansion was observed on day 7 and persisted for at least 6 months.

Published
2024
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210. Acute Cholecystitis Is a Common Complication after Allogeneic Stem Cell Transplantation and Is Associated with the Use of Total Parenteral Nutrition

Author

Bagley, Stephen J., Sehgal, Alison R., Gill, Saar, Frey, Noelle V., Hexner, Elizabeth O., Loren, Alison W., Mangan, James K., Porter, David L., Stadtmauer, Edward A., Reshef, Ran, and Luger, Selina M.

Abstract

The incidence and risk factors for acute cholecystitis after allogeneic hematopoietic stem cell transplantation (HSCT) are not well defined. Of 644 consecutive adult transplants performed at our institution between 2001 and 2011, acute cholecystitis occurred in the first year of transplant in 32 patients (5.0%). We conducted 2 retrospective case-control studies of this population to determine risk factors for cholecystitis after HSCT and to evaluate the performance of different methods of imaging to diagnosis cholecystitis in patients undergoing HSCT compared with non-HSCT patients. In the HSCT population, development of cholecystitis was associated with an increased 1-year overall mortality rate (62.5% versus 19.8%, P< .001). The risk of developing cholecystitis was higher in patients who received total parenteral nutrition (TPN) (adjusted odds ratio, 3.41; P = .009). There was a trend toward more equivocal abdominal ultrasound findings in HSCT recipients with acute cholecystitis compared with nontransplant patients (50.0% versus 30.6%, P = .06). However, hepatobiliary iminodiacetic acid (HIDA) scans were definitively positive for acute cholecystitis in most patients in both populations (80.0% of HSCT recipients versus 77.4% of control subjects, P = .82). In conclusion, acute cholecystitis is a common early complication of HSCT, the risk is increased in patients who receive TPN, and it is associated with high 1-year mortality. In HSCT recipients with findings suggestive of acute cholecystitis, especially those receiving TPN, early use of HIDA scan may be considered over ultrasound.

Published
2024
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211. Preconditioning Frailty Phenotype Influences Survival and Relapse for Older Allogeneic Transplantation Recipients

Author

Sung, Anthony D., Koll, Thuy, Gier, Shannon H., Racioppi, Alessandro, White, Griffin, Lew, Meagan, Free, Marcia, Agarwal, Priyal, Bohannon, Lauren M., Johnson, Ernaya J., Selvan, Bharathi, Babushok, Daria V., Frey, Noelle V., Gill, Saar I., Hexner, Elizabeth O., Martin, MaryEllen, Perl, Alexander E., Pratz, Keith W., Luger, Selina M., Chao, Nelson J., Fisher, Alfred L., Stadtmauer, Edward A., Porter, David L., Loren, Alison W., Bhatt, Vijaya R., Gimotty, Phyllis A., and McCurdy, Shannon R.

Abstract

•Older prefrail and frail patients have inferior survival after HCT due to relapse.•Septuagenarians have inferior survival after HCT due to nonrelapse mortality.•Age, frailty phenotype, Karnofsky Performance Status, and Disease Risk Index determine survival for older HCT recipients.•Disease risk index and frailty phenotype determine relapse for older HCT recipients.

Published
2024
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213. CAR T Cell Therapy in Acute Lymphoblastic Leukemia and Potential for Chronic Lymphocytic Leukemia.

Author

Singh, Nathan, Frey, Noelle, Grupp, Stephan, Maude, Shannon, Frey, Noelle V, Grupp, Stephan A, and Maude, Shannon L

Subjects
CHRONIC lymphocytic leukemia treatment, LYMPHOBLASTIC leukemia treatment, ANTIGENS, CELL receptors, CELLULAR therapy, CHRONIC lymphocytic leukemia, CLINICAL trials, IMMUNOTHERAPY, LYMPHOBLASTIC leukemia, RECOMBINANT proteins, T cells, TUMOR antigens, TREATMENT effectiveness
Abstract

Opinion Statement: Adoptive transfer of autologous T cells engineered to express a chimeric antigen receptor (CAR) represents a powerful targeted immunotherapy that has shown great promise in some of the most refractory leukemias. CAR-modified T cells directed against CD19 have led the way, setting a high standard with remission rates as high as 90 % in clinical trials for relapsed/refractory acute lymphoblastic leukemia (ALL). Yet, the first demonstration of efficacy was in another disease, chronic lymphocytic leukemia (CLL), in which CD19-targeted CAR T cells eradicated bulky, highly refractory disease. Despite early encouraging results, clinical trials in CLL have yielded lower response rates, revealing disease-specific differences in response in this form of immunotherapy. Ongoing research focused on identifying and overcoming these limitations, promises to improve response rates. Beyond the induction of remission, the transformative impact of engineered T cell therapy lies in its potential for long-term disease control. With longer follow-up and durable T cell persistence now reported, we are closer to answering the question of whether sustained remissions are possible with CAR T cell monotherapy. As might be expected with a highly effective therapy using a single mechanism of action, escape pathways have emerged. Combinatorial approaches are needed to anticipate and prevent this mode of relapse. Lastly, toxicity management is vital to ensure the safety of this exciting cancer immunotherapy. [ABSTRACT FROM AUTHOR]

Published
2016
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217. Unrelated donors are associated with improved relapse-free survival compared to related donors in patients with myelodysplastic syndrome undergoing reduced intensity allogeneic stem cell transplantation

Author

Yam, Clinton, primary, Crisalli, Lisa, additional, Luger, Selina M., additional, Loren, Alison W., additional, Hexner, Elizabeth O., additional, Frey, Noelle V., additional, Mangan, James K., additional, Gao, Amy, additional, Stadtmauer, Edward A., additional, Porter, David L., additional, and Reshef, Ran, additional

Published
2016
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219. Identification of Predictive Biomarkers for Cytokine Release Syndrome after Chimeric Antigen Receptor T-cell Therapy for Acute Lymphoblastic Leukemia

Author

Teachey, David T., primary, Lacey, Simon F., additional, Shaw, Pamela A., additional, Melenhorst, J. Joseph, additional, Maude, Shannon L., additional, Frey, Noelle, additional, Pequignot, Edward, additional, Gonzalez, Vanessa E., additional, Chen, Fang, additional, Finklestein, Jeffrey, additional, Barrett, David M., additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Berg, Robert A., additional, Aplenc, Richard, additional, Callahan, Colleen, additional, Rheingold, Susan R., additional, Zheng, Zhaohui, additional, Rose-John, Stefan, additional, White, Jason C., additional, Nazimuddin, Farzana, additional, Wertheim, Gerald, additional, Levine, Bruce L., additional, June, Carl H., additional, Porter, David L., additional, and Grupp, Stephan A., additional

Published
2016
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220. Optimizing chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL).

Author

Frey, Noelle V., primary, Shaw, Pamela A, additional, Hexner, Elizabeth O., additional, Gill, Saar, additional, Marcucci, Katherine, additional, Luger, Selina M., additional, Mangan, James K., additional, Grupp, Stephan A., additional, Maude, Shannon L., additional, Ericson, Solveig, additional, Levine, Bruce, additional, Lacey, Simon F., additional, Melenhorst, Jan J., additional, June, Carl H., additional, and Porter, David L., additional

Published
2016
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221. Randomized, phase II dose optimization study of chimeric antigen receptor (CAR) modified T cells directed against CD19 in patients (pts) with relapsed, refractory (R/R) CLL.

Author

Porter, David L., primary, Frey, Noelle V., additional, Melenhorst, Jan J., additional, Hwang, Wei-Ting, additional, Lacey, Simon F., additional, Shaw, Pamela A, additional, Chew, Anne, additional, Marcucci, Katherine, additional, Gill, Saar, additional, Loren, Alison W., additional, Mato, Anthony R., additional, Schuster, Stephen J., additional, Lledo, Lester, additional, McConville, Holly, additional, Gilmore, Joan, additional, Capobianchi, James, additional, Kalos, Michael D., additional, Grupp, Stephan A., additional, Levine, Bruce, additional, and June, Carl H., additional

Published
2016
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222. Sustained remissions with CD19-specific chimeric antigen receptor (CAR)-modified T cells in children with relapsed/refractory ALL.

Author

Maude, Shannon L., primary, Teachey, David T., additional, Rheingold, Susan R., additional, Shaw, Pamela A, additional, Aplenc, Richard, additional, Barrett, David Maxwell, additional, Barker, Christine S, additional, Callahan, Colleen, additional, Frey, Noelle V., additional, Nazimuddin, Farzana, additional, Lacey, Simon F., additional, Zheng, Zhaohui, additional, Levine, Bruce, additional, Melenhorst, Jan Joseph, additional, Motley, Laura, additional, Porter, David L., additional, June, Carl H., additional, and Grupp, Stephan A., additional

Published
2016
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223. Autologous stem cell transplantation in first complete remission may not extend progression-free survival in patients with peripheral T cell lymphomas

Author

Yam, Clinton, primary, Landsburg, Daniel J., additional, Nead, Kevin T., additional, Lin, Xinyi, additional, Mato, Anthony R., additional, Svoboda, Jakub, additional, Loren, Alison W., additional, Frey, Noelle V., additional, Stadtmauer, Edward A., additional, Porter, David L., additional, Schuster, Stephen J., additional, and Nasta, Sunita D., additional

Published
2016
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224. Infusion of CD3/CD28 costimulated umbilical cord blood T cells at the time of single umbilical cord blood transplantation may enhance engraftment

Author

Hexner, Elizabeth O., primary, Luger, Selina M., additional, Reshef, Ran, additional, Jeschke, Grace R., additional, Mangan, James K., additional, Frey, Noelle V., additional, Frank, Dale M., additional, Richman, Lee P., additional, Vonderheide, Robert H., additional, Aqui, Nicole A., additional, Rosenbach, Misha, additional, Zhang, Yi, additional, Chew, Anne, additional, Loren, Alison W., additional, Stadtmauer, Edward A., additional, Levine, Bruce L., additional, June, Carl H., additional, Emerson, Stephen G., additional, and Porter, David L., additional

Published
2016
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225. Time to unrelated donor leukocyte infusion is longer, but incidence of GVHD and overall survival are similar for recipients of unrelated DLI compared to matched sibling DLI

Author

Kumar, Anita J., primary, Vassilev, Pavel, additional, Loren, Alison W., additional, Luger, Selina M., additional, Reshef, Ran, additional, Gill, Saar, additional, Smith, Jacqueline, additional, Goldstein, Steven C., additional, Hexner, Elizabeth, additional, Stadtmauer, Edward A., additional, Porter, David, additional, and Frey, Noelle V., additional

Published
2016
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227. Higher Apheresis Blood Volumes Are Associated with a Reduction in Relapse Risk and Improved Survival in Patients Undergoing Reduced Intensity Allogeneic Transplants from Unrelated Donors, Potentially Due to Higher CD8 T-Cell Doses

Author

Crisalli, Lisa M., primary, Frey, Noelle V., additional, Hexner, Elizabeth O., additional, Hinkle, Joanne T., additional, Loren, Alison W., additional, Luger, Selina M., additional, Sell, Mary, additional, Stadtmauer, Edward A., additional, Porter, David L., additional, and Reshef, Ran, additional

Published
2016
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229. Biomarkers Accurately Predict Cytokine Release Syndrome (CRS) after Chimeric Antigen Receptor (CAR) T Cell Therapy for Acute Lymphoblastic Leukemia (ALL)

Author

Teachey, David T, primary, Lacey, Simon F., additional, Shaw, Pamela A, additional, Melenhorst, J Joseph, additional, Frey, Noelle V., additional, Maude, Shannon L, additional, Barrett, David M., additional, Aplenc, Richard, additional, Chen, Fang, additional, Fitzgerald, Julie, additional, Gonzalez, Vanessa, additional, Pequignot, Edward, additional, Rheingold, Susan R., additional, Weiss, Scott, additional, White, Jason C., additional, June, Carl H., additional, Porter, David L., additional, and Grupp, Stephan A., additional

Published
2015
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230. Unrelated Donors Are Associated with Improved Relapse Free Survival Compared to Related Donors in Patients with Myelodysplastic Syndrome Undergoing Reduced Intensity Conditioned Allogeneic Stem-Cell Transplantation

Author

Yam, Clinton, primary, Crisalli, Lisa, additional, Luger, Selina, additional, Loren, Alison, additional, Hexner, Elizabeth O, additional, Frey, Noelle, additional, Mangan, James, additional, Gao, Amy, additional, Stadtmauer, Edward A., additional, Porter, David, additional, and Reshef, Ran, additional

Published
2015
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232. Autologous Stem Cell Transplantation in First Complete Remission May Not Extend Progression Free Survival in Patients with ALK-Negative Peripheral T Cell Lymphoma

Author

Yam, Clinton, primary, Landsburg, Daniel J., additional, Lin, Xinyi, additional, Mato, Anthony, additional, Svoboda, Jakub, additional, Loren, Alison, additional, Frey, Noelle, additional, Stadtmauer, Edward A., additional, Porter, David, additional, Schuster, Stephen J., additional, and Dwivedy Nasta, Sunita, additional

Published
2015
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233. Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel.

Author

Porter, David, Frey, Noelle, Wood, Patricia A., Yanqiu Weng, and Grupp, Stephan A.

Abstract

Background: Anti-CD19 CAR T cell therapy has demonstrated high response rates in patients with relapsed or refractory (r/r) B cell malignancies but is associated with significant toxicity. Cytokine release syndrome (CRS) is the most significant complication associated with CAR T cell therapy, and it is critical to have a reproducible and easy method to grade CRS after CAR T cell infusions. Discussion: The Common Terminology Criteria for Adverse Events scale is inadequate for grading CRS associated with cellular therapy. Clinical experience with the anti-CD19 CAR T cell therapy tisagenlecleucel at the University of Pennsylvania (Penn) was used to develop the Penn grading scale for CRS. The Penn grading scale depends on easily accessible clinical features; does not rely on location of care or quantitation of supportive care; assigns grades to guide CRS management; distinguishes between mild, moderate, severe, and life-threatening CRS; and applies to both early-onset and delayed-onset CRS associated with T cell therapies. Clinical data from 55 pediatric patients with r/r B cell acute lymphoblastic leukemia and 42 patients with r/r chronic lymphocytic lymphoma treated with tisagenlecleucel were used to demonstrate the current application of the Penn grading scale. Conclusion: We show that the Penn grading scale provides reproducible CRS grading that can be useful to guide therapy and that can be applied across clinical trials and treatment platforms. [ABSTRACT FROM AUTHOR]

Published
2018
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234. Cytokine release syndrome: Who is at risk and how to treat.

Author

Frey, Noelle

Abstract

T-cell engaging therapies such as blinatumomab and anti-CD19 chimeric antigen receptor (CAR) T cells have revolutionized our approach to patients with relapsed and refractory acute lymphoblastic leukemia (ALL). However, the immune activation responsible for high remission rates is also responsible for the unique treatment-related toxicity of cytokine release syndrome (CRS). The clinical signs of CRS include fever, hemodynamic instability, and capillary leak, which correlate with T-cell activation and elevated cytokine levels. Tocilizumab, an anti-IL-6 receptor antagonist, provides control of severe CRS induced by CAR T cells without being directly T cell toxic. With blinatumomab, the approach to CRS has been largely preventative with administration strategies that include disease cytoreduction, corticosteroid premedication, and dose titration. [ABSTRACT FROM AUTHOR]

Published
2017
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235. Clinical utilization of Chimeric Antigen Receptor T-cells (CAR-T) in B-cell acute lymphoblastic leukemia (ALL)–an expert opinion from the European Society for Blood and Marrow Transplantation (EBMT) and the American Society for Blood and Marrow Transplantation (ASBMT)

Author

Kansagra, Ankit J., Frey, Noelle V., Bar, Merav, Laetsch, Theodore W., Carpenter, Paul A., Savani, Bipin N., Heslop, Helen E., Bollard, Catherine M., Komanduri, Krishna V., Gastineau, Dennis A., Chabannon, Christian, Perales, Miguel A., Hudecek, Michael, Aljurf, Mahmoud, Andritsos, Leslie, Barrett, John A., Bachanova, Veronika, Bonini, Chiara, Ghobadi, Armin, Gill, Saar I., Hill, Joshua A., Kenderian, Saad, Kebriaei, Partow, Nagler, Arnon, Maloney, David, Liu, Hien D., Shah, Nirali N., Kharfan-Dabaja, Mohamed A., Shpall, Elizabeth J., Mufti, Ghulam J., Johnston, Laura, Jacoby, Elad, Bazarbachi, Ali, DiPersio, John F., Pavletic, Steven Z., Porter, David L., Grupp, Stephan A., Sadelain, Michel, Litzow, Mark R., Mohty, Mohamad, and Hashmi, Shahrukh K.

Abstract

On August 30, 2017, the U.S. Food and Drug Administration (US-FDA) approved tisagenlecleucel (KYMRIAH, Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor-T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring and disease assessments. To address these issues, experts representing the American Society for Blood and Marrow Transplant (ASBMT), the European Group for Blood and Marrow Transplantation (EBMT), the International Society of Cell and Gene Therapy (ISCT), and the Foundation for the Accreditation of Cellular Therapy (FACT), formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved.

Published
2019
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236. Eltrombopag treatment during induction chemotherapy for acute myeloid leukaemia: a randomised, double-blind, phase 2 study

Author

Frey, Noelle, Jang, Jun Ho, Szer, Jeff, Illés, Árpád, Kim, Hee-Je, Ram, Ron, Chong, Beng H, Rowe, Jacob M, Borisenkova, Elena, Liesveld, Jane, Winer, Eric S, Cherfi, Azzeddine, Aslanis, Vassilios, Ghaznawi, Farhat, and Strickland, Stephen

Abstract

Patients with acute myeloid leukaemia frequently have thrombocytopenia during induction chemotherapy. Eltrombopag, an oral thrombopoietin receptor agonist, stimulates platelet production by a similar mechanism to endogenous thrombopoietin. This study investigated safety and efficacy of eltrombopag versus placebo during anthracycline-based induction treatment of patients with acute myeloid leukaemia.

Published
2019
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237. Tocilizumab for the treatment of severe steroid-refractory acute graft-versus-host disease of the lower gastrointestinal tract

Author

Ganetsky, Alex, Frey, Noelle, Hexner, Elizabeth, Loren, Alison, Gill, Saar, Luger, Selina, Mangan, James, Martin, Mary, Babushok, Daria, Drobyski, William, Smith, Jacqueline, Timlin, Colleen, Freyer, Craig, Stadtmauer, Edward, and Porter, David

Abstract

Steroid-refractory (SR) acute gastrointestinal (GI) graft-versus-host disease (GVHD) is associated with significant mortality in allogeneic hematopoietic cell transplantation recipients. We retrospectively evaluated the efficacy of tocilizumab for the treatment of SR biopsy-proven acute lower GI GVHD in 16 consecutive adult transplant recipients between October 2015 and July 2016. Tocilizumab 8 mg/kg was administered every 2 weeks until achievement of complete response, defined as resolution of all manifestations of GI GVHD, or until patients had progression or initiation of other therapy. Ten of 16 patients (62.5%; 95% CI, 0.39–82) achieved a complete response after a median time of 11 days (range, 2–28 days) from tocilizumab initiation. The median time to response onset (improvement in stage by at least 1) was 1 day (range, 1–4 days). Tocilizumab was administered at a median of 9 days (range, 3–75 days) from GVHD diagnosis and 10 days (range, 3–75 days) from initiation of high-dose steroids. At a median follow-up of 7.6 months (range, 0.8–27.7 months) from initiation of tocilizumab, 6/16 (37.5%) patients are alive and free of their underlying hematologic malignancy. Tocilizumab appears to be a highly active agent for the treatment of severe SR lower GI acute GVHD.

Published
2019
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238. S115: CONSOLIDATION WITH BLINATUMOMAB IMPROVES OVERALL AND RELAPSE-FREE SURVIVAL IN PATIENTS WITH NEWLY DIAGNOSED B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: IMPACT OF AGE AND MRD LEVEL IN ECOG-ACRIN E1910.

Author

Litzow, Mark, Sun, Zhuoxin, Mattison, Ryan, Paietta, Elisabeth, Mullighan, Charles, Roberts, Kathryn, Zhang, Yanming, Racevskis, Janis, Willman, Cheryl, Wieduwilt, Matthew, Liedtke, Michaela, Bergeron, Julie, Lazarus, Hillard, Arber, Dan, Wood, Brent, Rowe, Jacob, Pratz, Keith, Dinner, Shira, Frey, Noelle, and Gore, Steve

Published
2023
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239. Cytokine Release Syndrome Results in Reduced AML Killing By CD123 CAR T Cells

Author

Bhagwat, Anand S, Torres, Leonel, Shestova, Olga, Shestov, Maksim, Frey, Noelle V., Hexner, Elizabeth O, Luger, Selina M, Loren, Alison W, Martin, Mary Ellen, McCurdy, Shannon R, Perl, Alexander, Stadtmauer, Edward A., Mangan, James K., Brogdon, Jennifer, Fraietta, Joseph A, Hwang, Wei-Ting, Siegel, Don L., Kenderian, Saad S., Porter, David L., June, Carl, and Gill, Saar

Abstract

Background: Chimeric antigen receptor (CAR) T cells have repeatedly demonstrated capacity to induce high rates of response and durable remissions for B cell cancers. In contrast, CAR T cells for the treatment of acute myeloid leukemia (AML) have not yet achieved this impact. We previously demonstrated that CD123 is expressed on AML blasts at high frequency, thus making it an attractive target antigen for AML-directed CAR T cells.

Published
2023
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240. Evolving Racial/Ethnic Disparities in AML Survival in the Novel Therapy Era: Real-World Evidence of Improved Survival in Older Patients with the Largest Improvement in Non-Hispanic Black Patients

Author

Wang, Xin, Gimotty, Phyllis, Matthews, Andrew H, Mamtani, Ronac, Luger, Selina M, Hexner, Elizabeth O, Babushok, Daria V, McCurdy, Shannon R, Frey, Noelle V., Jordan Bruno, Ximena, Porter, David L., Gill, Saar, Martin, Mary Ellen, Paralkar, Vikram R, Maillard, Ivan, Loren, Alison W, Perl, Alexander, Pratz, Keith W, Getz, Kelly D., and Lai, Catherine

Abstract

Introduction:The approval of venetoclax (VEN)-based frontline therapy for acute myeloid leukemia (AML) in November 2018 marks a new era of AML care. Racial/ethnic disparities have been increasingly recognized in AML with historically inferior outcomes reported in non-Hispanic Black (NHB) patients relative to non-Hispanic White (NHW) patients. The advances of novel therapeutics offer an unprecedented opportunity to narrow the care gaps between patient groups; but they also create new challenges related to testing, clinical decision-making, and care coordination. Currently, little is known about the impact of race/ethnicity on the recent advances in AML management. We performed a retrospective analysis leveraging real-world data to examine the magnitude and mechanisms of racial/ethnic disparities in modern AML care.

Published
2023
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242. Durable Remissions with Humanized CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells in CAR-Naive and CAR-Exposed Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia

Author

Maude, Shannon L, Hucks, George E, Callahan, Colleen, Baniewicz, Diane, Fasano, Christina, Barker, Christine, Rheingold, Susan R., Aplenc, Richard, Dinofia, Amanda M., Li, Amanda, Teachey, David T, Barrett, David M., Brogdon, Jennifer, Young, Regina M, Scholler, John, Marcucci, Katherine T, Levine, Bruce L, Frey, Noelle, Porter, David L, Lacey, Simon F, Melenhorst, J. Joseph, June, Carl H, and Grupp, Stephan A

Published
2017
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245. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia

Author

Porter, David L., primary, Hwang, Wei-Ting, additional, Frey, Noelle V., additional, Lacey, Simon F., additional, Shaw, Pamela A., additional, Loren, Alison W., additional, Bagg, Adam, additional, Marcucci, Katherine T., additional, Shen, Angela, additional, Gonzalez, Vanessa, additional, Ambrose, David, additional, Grupp, Stephan A., additional, Chew, Anne, additional, Zheng, Zhaohui, additional, Milone, Michael C., additional, Levine, Bruce L., additional, Melenhorst, Jan J., additional, and June, Carl H., additional

Published
2015
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247. Outpatient Autologous Stem Cell Transplantation for Patients With Myeloma

Author

Paul, Thomas M., primary, Liu, Stephen V., additional, Chong, Elise A., additional, Luger, Selina M., additional, Porter, David L., additional, Schuster, Stephen J., additional, Tsai, Donald E., additional, Nasta, Sunita D., additional, Loren, Alison, additional, Frey, Noelle, additional, Perl, Alexander, additional, Cohen, Adam D., additional, Weiss, Brendan M., additional, Stadtmauer, Edward A., additional, and Vogl, Dan T., additional

Published
2015
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