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1,039 results on '"Miklos, David B."'

1. CD22 CAR T cells demonstrate high response rates and safety in pediatric and adult B-ALL: Phase 1b results

Author

Schultz, Liora M., Jeyakumar, Nikeshan, Kramer, Anne Marijn, Sahaf, Bita, Srinagesh, Hrishi, Shiraz, Parveen, Agarwal, Neha, Hamilton, Mark, Erickson, Courtney, Jacobs, Ashley, Moon, Jennifer, Baggott, Christina, Arai, Sally, Bharadwaj, Sushma, Johnston, Laura J., Liedtke, Michaela, Lowsky, Robert, Meyer, Everett, Negrin, Robert, Rezvani, Andrew, Shizuru, Judy, Sidana, Surbhi, Egeler, Emily, Mavroukakis, Sharon, Tunuguntla, Ramya, Gkitsas-Long, Nikolaos, Retherford, Aidan, Brown, Annie Kathleen, Gramstrap-Petersen, Anne-Louise, Ibañez, Raquel Martin, Feldman, Steven A., Miklos, David B., Mackall, Crystal L., Davis, Kara L., Frank, Matthew, Ramakrishna, Sneha, and Muffly, Lori

Published
2024
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2. Galectin-3 predicts acute GvHD and overall mortality post reduced intensity allo-HCT: a BMT-CTN biorepository study

Author

McCarthy, Philip L., Attwood, Kristopher M., Liu, Xiaojun, Chen, George L., Minderman, Hans, Alousi, Amin, Bashey, Asad, Lowsky, Robert, Miklos, David B., Hansen, John, Westervelt, Peter, Yanik, Gregory, Waller, Edmund K., Howard, Alan, Blazar, Bruce R., Wallace, Paul K., Reshef, Ran, Horowitz, Mary M., Maziarz, Richard T., Levine, John E., and Mohammadpour, Hemn

Published
2024
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3. CD22-directed CAR T-cell therapy for large B-cell lymphomas progressing after CD19-directed CAR T-cell therapy: a dose-finding phase 1 study

Author

Klysz, Dorota Danuta, Gkitsas-Long, Nikolaos, Bacigalupi, Juliana, Iglesias, Maria, Crawford, Emma, Nichols, Linnea, Cunanan, Kristen, Tamaresis, John, Spiegel, Jay Y., Ehlinger, Zachary, Kuo, Adam, Reynolds, Warren D., Arai, Sally, Johnston, Laura, Lowsky, Robert, Meyer, Everett, Negrin, Robert S., Rezvani, Andrew R., Shiraz, Parveen, Sidana, Surbhi, Weng, Wen Kai, Bharadwaj, Sushma, Dahiya, Saurabh, Smith, Melody, Schultz, Liora M., Ramakrishna, Sneha, Davis, Kara L., Tunuguntla, Ramya, Frank, Matthew J, Baird, John H, Kramer, Anne Marijn, Srinagesh, Hrishikesh K, Patel, Shabnum, Brown, Annie Kathleen, Oak, Jean S, Younes, Sheren F, Natkunam, Yasodha, Hamilton, Mark P, Su, Yi-Jiun, Agarwal, Neha, Chinnasamy, Harshini, Egeler, Emily, Mavroukakis, Sharon, Feldman, Steven A, Sahaf, Bita, Mackall, Crystal L, Muffly, Lori, and Miklos, David B

Published
2024
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4. Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity

Author

Locke, Frederick L., Siddiqi, Tanya, Jacobson, Caron A., Ghobadi, Armin, Ahmed, Sairah, Miklos, David B., Perales, Miguel-Angel, Munoz, Javier, Fingrut, Warren B., Pennisi, Martina, Gauthier, Jordan, Shadman, Mazyar, Gowda, Lohith, Mirza, Abu-Sayeef, Abid, Muhammad Bilal, Hong, Sanghee, Majhail, Navneet S., Kharfan-Dabaja, Mohamed A., Khurana, Arushi, Badar, Talha, Lin, Yi, Bennani, N. Nora, Herr, Megan M., Hu, Zhen-Huan, Wang, Hai-Lin, Baer, Anjani, Baro, Elande, Miao, Harry, Spooner, Clare, Xu, Hairong, and Pasquini, Marcelo C.

Published
2024
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5. CAR19 monitoring by peripheral blood immunophenotyping reveals histology-specific expansion and toxicity

Author

Hamilton, Mark P., Craig, Erin, Gentille Sanchez, Cesar, Mina, Alain, Tamaresis, John, Kirmani, Nadia, Ehlinger, Zachary, Syal, Shriya, Good, Zinaida, Sworder, Brian, Schroers-Martin, Joseph, Lu, Ying, Muffly, Lori, Negrin, Robert S., Arai, Sally, Lowsky, Robert, Meyer, Everett, Rezvani, Andrew R., Shizuru, Judith, Weng, Wen-Kai, Shiraz, Parveen, Sidana, Surbhi, Bharadwaj, Sushma, Smith, Melody, Dahiya, Saurabh, Sahaf, Bita, Kurtz, David M., Mackall, Crystal L., Tibshirani, Robert, Alizadeh, Ash A., Frank, Matthew J., and Miklos, David B.

Published
2024
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8. Single-center randomized trial of T-reg graft alone vs T-reg graft plus tacrolimus for the prevention of acute GVHD

Author

Bader, Cameron S., Pavlova, Anna, Lowsky, Robert, Muffly, Lori S., Shiraz, Parveen, Arai, Sally, Johnston, Laura J., Rezvani, Andrew R., Weng, Wen-Kai, Miklos, David B., Frank, Matthew J., Tamaresis, John S., Agrawal, Vaibhav, Bharadwaj, Sushma, Sidana, Surbhi, Shizuru, Judith A., Fernhoff, Nathaniel B., Putnam, Amy, Killian, Scott, Xie, Bryan J., Negrin, Robert S., and Meyer, Everett H.

Published
2024
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11. Improved outcomes for relapsed/refractory Hodgkin lymphoma after autologous transplantation in the era of novel agents

Author

Spinner, Michael A., Sica, R. A., Tamaresis, John S., Lu, Ying, Chang, Cheryl, Lowsky, Robert, Frank, Matthew J., Johnston, Laura J., Miklos, David B., Muffly, Lori S., Negrin, Robert S., Rezvani, Andrew R., Shiraz, Parveen, Shizuru, Judith A., Weng, Wen-Kai, Binkley, Michael S., Hoppe, Richard T., Advani, Ranjana H., and Arai, Sally

Published
2023
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12. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma

Author

Neelapu, Sattva S., Jacobson, Caron A., Ghobadi, Armin, Miklos, David B., Lekakis, Lazaros J., Oluwole, Olalekan O., Lin, Yi, Braunschweig, Ira, Hill, Brian T., Timmerman, John M., Deol, Abhinav, Reagan, Patrick M., Stiff, Patrick, Flinn, Ian W., Farooq, Umar, Goy, Andre H., McSweeney, Peter A., Munoz, Javier, Siddiqi, Tanya, Chavez, Julio C., Herrera, Alex F., Bartlett, Nancy L., Bot, Adrian A., Shen, Rhine R., Dong, Jinghui, Singh, Kanwarjit, Miao, Harry, Kim, Jenny J., Zheng, Yan, and Locke, Frederick L.

Published
2023
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13. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.

Author

Nastoupil, Loretta J, Jain, Michael D, Feng, Lei, Spiegel, Jay Y, Ghobadi, Armin, Lin, Yi, Dahiya, Saurabh, Lunning, Matthew, Lekakis, Lazaros, Reagan, Patrick, Oluwole, Olalekan, McGuirk, Joseph, Deol, Abhinav, Sehgal, Alison R, Goy, Andre, Hill, Brian T, Vu, Khoan, Andreadis, Charalambos, Munoz, Javier, Westin, Jason, Chavez, Julio C, Cashen, Amanda, Bennani, N Nora, Rapoport, Aaron P, Vose, Julie M, Miklos, David B, Neelapu, Sattva S, and Locke, Frederick L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Lymphoma, Hematology, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Antigens, CD19, Biological Products, Clinical Trials, Phase II as Topic, Comorbidity, Cytokine Release Syndrome, Female, Humans, Immunotherapy, Adoptive, L-Lactate Dehydrogenase, Leukapheresis, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Organizational Policy, Patient Selection, Progression-Free Survival, Recurrence, Retrospective Studies, Severity of Illness Index, Standard of Care, Survival Rate, Young Adult, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeAxicabtagene 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 methodsData 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.ResultsOf 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.ConclusionThe safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial.

Published
2020

15. Tumor immune contexture is a determinant of anti-CD19 CAR T cell efficacy in large B cell lymphoma

Author

Scholler, Nathalie, Perbost, Regis, Locke, Frederick L., Jain, Michael D., Turcan, Sarah, Danan, Corinne, Chang, Edmund C., Neelapu, Sattva S., Miklos, David B., Jacobson, Caron A., Lekakis, Lazaros J., Lin, Yi, Ghobadi, Armin, Kim, Jenny J., Chou, Justin, Plaks, Vicki, Wang, Zixing, Xue, Allen, Mattie, Mike, Rossi, John M., Bot, Adrian, and Galon, Jérôme

Published
2022
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16. Post-infusion CAR TReg cells identify patients resistant to CD19-CAR therapy

Author

Good, Zinaida, Spiegel, Jay Y., Sahaf, Bita, Malipatlolla, Meena B., Ehlinger, Zach J., Kurra, Sreevidya, Desai, Moksha H., Reynolds, Warren D., Wong Lin, Anita, Vandris, Panayiotis, Wu, Fang, Prabhu, Snehit, Hamilton, Mark P., Tamaresis, John S., Hanson, Paul J., Patel, Shabnum, Feldman, Steven A., Frank, Matthew J., Baird, John H., Muffly, Lori, Claire, Gursharan K., Craig, Juliana, Kong, Katherine A., Wagh, Dhananjay, Coller, John, Bendall, Sean C., Tibshirani, Robert J., Plevritis, Sylvia K., Miklos, David B., and Mackall, Crystal L.

Published
2022
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17. Risk of Second Tumors and T-Cell Lymphoma after CAR T-Cell Therapy

Author

Hamilton, Mark P., primary, Sugio, Takeshi, additional, Noordenbos, Troy, additional, Shi, Shuyu, additional, Bulterys, Philip L., additional, Liu, Chih Long, additional, Kang, Xiaoman, additional, Olsen, Mari N., additional, Good, Zinaida, additional, Dahiya, Saurabh, additional, Frank, Matthew J., additional, Sahaf, Bita, additional, Mackall, Crystal L., additional, Gratzinger, Dita, additional, Diehn, Maximilian, additional, Alizadeh, Ash A., additional, and Miklos, David B., additional

Published
2024
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19. Severity of Cytokine Release Syndrome Influences Outcome After Axicabtagene Ciloleucel for Large B cell Lymphoma: Results from the US Lymphoma CAR-T Consortium

Author

Jacobs, Miriam T., Jain, Michael D., Gao, Feng, Nastoupil, Loretta J., Spiegel, Jay Y., Lin, Yi, Dahiya, Saurabh, Lunning, Matthew, Lekakis, Lazaros, Reagan, Patrick M., Oluwole, Olalekan O., McGuirk, Joseph, Deol, Abhinav, Sehgal, Alison, Goy, Andre, Hill, Brian T., Andreadis, Charalambos, Munoz, Javier, Chavez, Julio C., Bennani, N. Nora, Rapoport, Aaron P., Vose, Julie M., Miklos, David B., Neelapu, Sattva S., Ghobadi, Armin, and Locke, Frederick L.

Published
2022
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20. Targeting PI3Kδ function for amelioration of murine chronic graft-versus-host disease

Author

Paz, Katelyn, Flynn, Ryan, Du, Jing, Tannheimer, Stacey, Johnson, Amy J, Dong, Shuai, Stark, Anne-Katrien, Okkenhaug, Klaus, Panoskaltsis-Mortari, Angela, Sage, Peter T, Sharpe, Arlene H, Luznik, Leo, Ritz, Jerome, Soiffer, Robert J, Cutler, Corey S, Koreth, John, Antin, Joseph H, Miklos, David B, MacDonald, Kelli P, Hill, Geoffrey R, Maillard, Ivan, Serody, Jonathan S, Murphy, William J, Munn, David H, Feser, Colby, Zaiken, Michael, Vanhaesebroeck, Bart, Turka, Laurence A, Byrd, John C, and Blazar, Bruce R

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Infectious Diseases, Rare Diseases, Transplantation, Prevention, Stem Cell Research, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Good Health and Well Being, Animals, B-Lymphocytes, Bone Marrow Transplantation, Bronchiolitis Obliterans, Chronic Disease, Class I Phosphatidylinositol 3-Kinases, Disease Models, Animal, Graft vs Host Disease, Humans, Mice, Mice, Inbred BALB C, Mice, Inbred C57BL, Mice, Knockout, Mice, Mutant Strains, Phosphoinositide-3 Kinase Inhibitors, Scleroderma, Localized, T-Lymphocytes, Helper-Inducer, basic (laboratory) research, science, graft-versus-host disease, immunobiology, immunosuppressant - other, basic (laboratory) research/science, Medical and Health Sciences, Surgery, Clinical sciences
Abstract

Chronic graft-versus-host disease (cGVHD) is a leading cause of morbidity and mortality following allotransplant. Activated donor effector T cells can differentiate into pathogenic T helper (Th)-17 cells and germinal center (GC)-promoting T follicular helper (Tfh) cells, resulting in cGVHD. Phosphoinositide-3-kinase-δ (PI3Kδ), a lipid kinase, is critical for activated T cell survival, proliferation, differentiation, and metabolism. We demonstrate PI3Kδ activity in donor T cells that become Tfh cells is required for cGVHD in a nonsclerodermatous multiorgan system disease model that includes bronchiolitis obliterans (BO), dependent upon GC B cells, Tfhs, and counterbalanced by T follicular regulatory cells, each requiring PI3Kδ signaling for function and survival. Although B cells rely on PI3Kδ pathway signaling and GC formation is disrupted resulting in a substantial decrease in Ig production, PI3Kδ kinase-dead mutant donor bone marrow-derived GC B cells still supported BO cGVHD generation. A PI3Kδ-specific inhibitor, compound GS-649443, that has superior potency to idelalisib while maintaining selectivity, reduced cGVHD in mice with active disease. In a Th1-dependent and Th17-associated scleroderma model, GS-649443 effectively treated mice with active cGVHD. These data provide a foundation for clinical trials of US Food and Drug Administration (FDA)-approved PI3Kδ inhibitors for cGVHD therapy in patients.

Published
2019

24. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma

Author

Neelapu, Sattva S, Locke, Frederick L, Bartlett, Nancy L, Lekakis, Lazaros J, Miklos, David B, Jacobson, Caron A, Braunschweig, Ira, Oluwole, Olalekan O, Siddiqi, Tanya, Lin, Yi, Timmerman, John M, Stiff, Patrick J, Friedberg, Jonathan W, Flinn, Ian W, Goy, Andre, Hill, Brian T, Smith, Mitchell R, Deol, Abhinav, Farooq, Umar, McSweeney, Peter, Munoz, Javier, Avivi, Irit, Castro, Januario E, Westin, Jason R, Chavez, Julio C, Ghobadi, Armin, Komanduri, Krishna V, Levy, Ronald, Jacobsen, Eric D, Witzig, Thomas E, Reagan, Patrick, Bot, Adrian, Rossi, John, Navale, Lynn, Jiang, Yizhou, Aycock, Jeff, Elias, Meg, Chang, David, Wiezorek, Jeff, and Go, William Y

Subjects
Rare Diseases, Orphan Drug, Lymphoma, Patient Safety, Clinical Research, Hematology, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Adult, Aged, Antigens, CD19, Biomarkers, Disease-Free Survival, Female, Humans, Immunotherapy, Adoptive, Interleukins, Lymphoma, Large B-Cell, Diffuse, Male, Middle Aged, Nervous System Diseases, Neutropenia, Receptors, Antigen, T-Cell, Survival Rate, T-Lymphocytes, Young Adult, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundIn a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy.MethodsIn this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine. The primary end point was the rate of objective response (calculated as the combined rates of complete response and partial response). Secondary end points included overall survival, safety, and biomarker assessments.ResultsAmong the 111 patients who were enrolled, axi-cel was successfully manufactured for 110 (99%) and administered to 101 (91%). The objective response rate was 82%, and the complete response rate was 54%.With a median follow-up of 15.4 months, 42% of the patients continued to have a response, with 40% continuing to have a complete response. The overall rate of survival at 18 months was 52%. The most common adverse events of grade 3 or higher during treatment were neutropenia (in 78% of the patients), anemia (in 43%), and thrombocytopenia (in 38%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 13% and 28% of the patients, respectively. Three of the patients died during treatment. Higher CAR T-cell levels in blood were associated with response.ConclusionsIn this multicenter study, patients with refractory large B-cell lymphoma who received CAR T-cell therapy with axi-cel had high levels of durable response, with a safety profile that included myelosuppression, the cytokine release syndrome, and neurologic events. (Funded by Kite Pharma and the Leukemia and Lymphoma Society Therapy Acceleration Program; ZUMA-1 ClinicalTrials.gov number, NCT02348216 .).

Published
2017

25. Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B‐cell lymphoma after 2 or more lines of prior therapy

Author

Lunning, Matthew A., primary, Wang, Hai‐lin, additional, Hu, Zhen‐Huan, additional, Locke, Frederick L., additional, Siddiqi, Tanya, additional, Jacobson, Caron A., additional, Ahmed, Sairah, additional, Miklos, David B., additional, Lin, Yi, additional, Hill, Brian T., additional, Ghobadi, Armin, additional, Neelapu, Sattva S., additional, Westin, Jason, additional, Dieyi, Chrisopher, additional, Field, Polly, additional, Miao, Harry, additional, Shahani, Shilpa A., additional, Patel, Anik, additional, Spooner, Clare, additional, Fu, Christine, additional, Muramoto, David, additional, Xu, Hairong, additional, and Pasquini, Marcelo C., additional

Published
2024
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26. Outcomes of subsequent anti-lymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7

Author

Ghobadi, Armin, primary, Munoz, Javier, additional, Westin, Jason R, additional, Locke, Frederick L, additional, Miklos, David B, additional, Rapoport, Aaron P., additional, Perales, Miguel-Angel, additional, Reagan, Patrick M, additional, McGuirk, Joseph P, additional, Jacobson, Caron A., additional, Kersten, Marie José, additional, Avivi, Irit, additional, Peng, Andrew, additional, Schupp, Marco, additional, To, Christina, additional, and Oluwole, Olalekan O, additional

Published
2024
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27. CAR19 Therapy Drives Expansion of Clonal Hematopoiesis and Associated Cytopenias

Author

Hamilton, Mark P., primary, Sworder, Brian, additional, Alig, Stefan, additional, Good, Zinaida, additional, Boegeholz, Jan, additional, Schroers-Martin, Joseph, additional, Tamaresis, John, additional, Esfahani, Mohammad, additional, Lu, Ying, additional, Olsen, Mari, additional, Liu, Chih Long, additional, Ehlinger, Zachary, additional, Desai, Moksha, additional, Liu-Fei, Felicia, additional, Muffly, Lori S, additional, Negrin, Robert S., additional, Arai, Sally, additional, Johnston, Laura, additional, Lowsky, Robert, additional, Meyer, Everett H., additional, Rezvani, Andrew R., additional, Shizuru, Judith A., additional, Weng, Wen-Kai, additional, Shiraz, Parveen, additional, Sidana, Surbhi, additional, Bharadwaj, Sushma, additional, Smith, Melody, additional, Dahiya, Saurabh, additional, Sahaf, Bita, additional, Diehn, Max, additional, Frank, Matthew J., additional, Mackall, Crystal L., additional, Kurtz, David, additional, Miklos, David B., additional, and Alizadeh, Ash A., additional

Published
2024
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29. CD19 Antigen Density Down-Regulation at Time of Progression in Large B-Cell Lymphoma Patients Treated with Axicabtagene Ciloleucel

Author

Spiegel, Jay, primary, Oak, Jean S., additional, Goyal, Anmol, additional, Bornheimer, Scott, additional, Irvine, Allison, additional, Shen, Rhine R., additional, Kong, Katherine A., additional, Bharadwaj, Sushma, additional, Weng, Wen-Kai, additional, Smith, Melody, additional, Frank, Matthew J., additional, Dahiya, Saurabh, additional, and Miklos, David B., additional

Published
2024
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30. Effective Prevention of Steroid-Requiring Chronic Gvhd with B Cell Depletion: A Randomized, Placebo-Controlled Trial

Author

Cutler, Corey, primary, Kim, Haesook T, additional, Banna, Hassan El, additional, Halloran, Elizabeth, additional, Matozel, Emily, additional, Ho, Vincent, additional, Koreth, John, additional, Gooptu, Mahasweta, additional, Shapiro, Roman M., additional, Kelkar, Amar H., additional, Gibson, Chris J., additional, Reynolds, Carol, additional, Ansuinelli, Michela, additional, Tamada, Rayuko, additional, Au, Chloe, additional, DeFilipp, Zachariah, additional, El-Jawahri, Areej, additional, Chen, Dr. Yi-Bin, additional, Jurdi, Najla El, additional, Weisdorf, Daniel J., additional, Couriel, Daniel R., additional, Lee, Catherine J., additional, Sahaf, Bita, additional, Craig, Juliana, additional, Ji, Kathleen, additional, Soiffer, Robert, additional, Antin, Joseph H., additional, Miklos, David B., additional, and Ritz, Jerome, additional

Published
2024
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31. Real Time, Point-of-Need Measurement of Blood CD19 CAR-T Vector Load Is Concordant with Standard Ddpcr Method

Author

Bharadwaj, Sushma, primary, Smith, Courtney J, additional, Nater, Jenny, additional, Vardhanabhuti, Saran, additional, Mallampet, Jayasindhu, additional, Elkordy, Sarah, additional, Fang, Jing, additional, Twoy, Abigail, additional, Syal, Shriya, additional, Broos, Katrijn, additional, Wuyts, Jan, additional, Braem, Gorik, additional, Adriany, Tom, additional, Metsu, Sofie, additional, Maertens, Geert, additional, Mattie, Mike, additional, Sahaf, Bita, additional, Kong, Katherine A., additional, Smith, Melody, additional, Frank, Matthew J., additional, Dahiya, Saurabh, additional, Shen, Rhine R., additional, and Miklos, David B., additional

Published
2024
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32. Analysis of PET-CT Derived Radiomic Biomarkers with Efficacy, Safety, and Expansion of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed or Refractory Large B-Cell Lymphoma (LBCL)

Author

Bharadwaj, Sushma, primary, Lau, Eric, additional, Hashmi, Ayesha, additional, Hamilton, Mark P., additional, Jensen, Alexandria, additional, Goyal, Anmol, additional, Marar, Mallika, additional, Lee, Caroline, additional, Ananth, Snegha, additional, Sahaf, Bita, additional, Mallampet, Jayasindhu, additional, Ehlinger, Zachary, additional, Syal, Shriya, additional, Patil, Sunita, additional, Guo, Henry, additional, Smith, Melody, additional, Weng, Wen-Kai, additional, Frank, Matthew J., additional, Binkley, Michael S, additional, Miklos, David B., additional, and Dahiya, Saurabh, additional

Published
2024
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33. Clinical Features of Neurotoxicity Following CD19 CAR T-cell Therapy in Mantle Cell Lymphoma

Author

Nie, Esther H., primary, Su, Yi-Jiun, additional, Baird, John H., additional, Agarwal, Neha, additional, Bharadwaj, Sushma, additional, Weng, Wen-Kai, additional, Smith, Melody, additional, Dahiya, Saurabh, additional, Han, May H., additional, Dunn, Jeffrey E., additional, Kipp, Lucas B., additional, Miklos, David B, additional, Scott, Brian J., additional, and Frank, Matthew J., additional

Published
2024
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34. Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy in refractory large B-cell lymphoma

Author

Neelapu, Sattva S., Locke, Frederick L., Bartlett, Nancy L., Lekakis, Lazaros J., Reagan, Patrick M., Miklos, David B., Jacobson, Caron A., Braunschweig, Ira, Oluwole, Olalekan O., Siddiqi, Tanya, Lin, Yi, Crump, Michael, Kuruvilla, John, Van Den Neste, Eric, Farooq, Umar, Navale, Lynn, DePuy, Venita, Kim, Jenny J., and Gisselbrecht, Christian

Published
2021
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35. Concordance of peripheral blood and bone marrow measurable residual disease in adult acute lymphoblastic leukemia

Author

Muffly, Lori, Sundaram, Vandana, Chen, Connie, Yurkiewicz, Ilana, Kuo, Eric, Burnash, Sarah, Spiegel, Jay Y., Arai, Sally, Frank, Matthew J., Johnston, Laura J., Lowsky, Robert, Meyer, Everett H., Negrin, Robert S., Rezvani, Andrew R., Sidana, Surbhi, Shiraz, Parveen, Shizuru, Judith A., Weng, Wen-Kai, Liedtke, Michaela, Vempaty, Hyma T., and Miklos, David B.

Published
2021
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36. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial

Author

Spiegel, Jay Y., Patel, Shabnum, Muffly, Lori, Hossain, Nasheed M., Oak, Jean, Baird, John H., Frank, Matthew J., Shiraz, Parveen, Sahaf, Bita, Craig, Juliana, Iglesias, Maria, Younes, Sheren, Natkunam, Yasodha, Ozawa, Michael G., Yang, Eric, Tamaresis, John, Chinnasamy, Harshini, Ehlinger, Zach, Reynolds, Warren, Lynn, Rachel, Rotiroti, Maria Caterina, Gkitsas, Nikolaos, Arai, Sally, Johnston, Laura, Lowsky, Robert, Majzner, Robbie G., Meyer, Everett, Negrin, Robert S., Rezvani, Andrew R., Sidana, Surbhi, Shizuru, Judith, Weng, Wen-Kai, Mullins, Chelsea, Jacob, Allison, Kirsch, Ilan, Bazzano, Magali, Zhou, Jing, Mackay, Sean, Bornheimer, Scott J., Schultz, Liora, Ramakrishna, Sneha, Davis, Kara L., Kong, Katherine A., Shah, Nirali N., Qin, Haiying, Fry, Terry, Feldman, Steven, Mackall, Crystal L., and Miklos, David B.

Published
2021
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37. Immune reconstitution and infectious complications following axicabtagene ciloleucel therapy for large B-cell lymphoma

Author

Baird, John H., Epstein, David J., Tamaresis, John S., Ehlinger, Zachary, Spiegel, Jay Y., Craig, Juliana, Claire, Gursharan K., Frank, Matthew J., Muffly, Lori, Shiraz, Parveen, Meyer, Everett, Arai, Sally, Brown, Janice (Wes), Johnston, Laura, Lowsky, Robert, Negrin, Robert S., Rezvani, Andrew R., Weng, Wen-Kai, Latchford, Theresa, Sahaf, Bita, Mackall, Crystal L., Miklos, David B., and Sidana, Surbhi

Published
2021
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38. CD22-directed CAR T-cell therapy for large B-cell lymphomas progressing after CD19-directed CAR T-cell therapy: a dose-finding phase 1 study

Author

Frank, Matthew J, Baird, John H, Kramer, Anne Marijn, Srinagesh, Hrishikesh K, Patel, Shabnum, Brown, Annie Kathleen, Oak, Jean S, Younes, Sheren F, Natkunam, Yasodha, Hamilton, Mark P, Su, Yi-Jiun, Agarwal, Neha, Chinnasamy, Harshini, Egeler, Emily, Mavroukakis, Sharon, Feldman, Steven A, Sahaf, Bita, Mackall, Crystal L, Muffly, Lori, Miklos, David B, Klysz, Dorota Danuta, Gkitsas-Long, Nikolaos, Bacigalupi, Juliana, Iglesias, Maria, Crawford, Emma, Nichols, Linnea, Cunanan, Kristen, Tamaresis, John, Spiegel, Jay Y., Ehlinger, Zachary, Kuo, Adam, Reynolds, Warren D., Arai, Sally, Johnston, Laura, Lowsky, Robert, Meyer, Everett, Negrin, Robert S., Rezvani, Andrew R., Shiraz, Parveen, Sidana, Surbhi, Weng, Wen Kai, Bharadwaj, Sushma, Dahiya, Saurabh, Smith, Melody, Schultz, Liora M., Ramakrishna, Sneha, Davis, Kara L., and Tunuguntla, Ramya

Abstract

Outcomes are poor for patients with large B-cell lymphoma who relapse after CD19-directed chimeric antigen receptor (CAR) T-cell therapy (CAR19). CD22 is a nearly universally expressed B-cell surface antigen and the efficacy of a CD22-directed CAR T-cell therapy (CAR22) in large B-cell lymphoma is unknown, which was what we aimed to examine in this study.

Published
2024
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41. Specificity of Immunoglobulin High-Throughput Sequencing Minimal Residual Disease Monitoring in Non-Hodgkin Lymphomas

Author

Shukla, Navika, primary, Schroers-Martin, Joseph, additional, Sworder, Brian, additional, Kathuria, Karan Raj, additional, Alig, Stefan, additional, Frank, Matthew J., additional, Miklos, David B, additional, Coutre, Steven E., additional, Diehn, Maximilian, additional, Khodadoust, Michael S, additional, Roschewski, Mark J., additional, Kurtz, David M., additional, and Alizadeh, Ash A, additional

Published
2023
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42. Galectin-3 predicts acute GvHD and overall mortality post reduced intensity allo-HCT: a BMT-CTN biorepository study

Author

McCarthy, Philip L., primary, Attwood, Kristopher M., additional, Liu, Xiaojun, additional, Chen, George L., additional, Minderman, Hans, additional, Alousi, Amin, additional, Bashey, Asad, additional, Lowsky, Robert, additional, Miklos, David B., additional, Hansen, John, additional, Westervelt, Peter, additional, Yanik, Gregory, additional, Waller, Edmund K., additional, Howard, Alan, additional, Blazar, Bruce R., additional, Wallace, Paul K., additional, Reshef, Ran, additional, Horowitz, Mary M., additional, Maziarz, Richard T., additional, Levine, John E., additional, and Mohammadpour, Hemn, additional

Published
2023
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43. Curative Potential of Axicabtagene Ciloleucel (Axi-Cel): An Exploratory Long-Term Survival Assessment in Patients with Refractory Large B-Cell Lymphoma from ZUMA-1

Author

Neelapu, Sattva S., primary, Jacobson, Caron A., additional, Ghobadi, Armin, additional, Miklos, David B., additional, Lekakis, Lazaros J., additional, Spooner, Clare, additional, Kim, Jenny J., additional, Miao, Harry, additional, Xue, Allen Xiaodong, additional, Zheng, Yan, additional, and Locke, Frederick L., additional

Published
2023
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44. Transcriptional Profiling Associated with CD22 CAR T Cell Clinical Response in LBCL

Author

Kramer, Anne Marijn, primary, Hamilton, Mark P., additional, Prabhu, Snehit, additional, Desai, Moksha, additional, Kuo, Adam, additional, Ehlinger, Zachary, additional, Agarwal, Neha, additional, Su, Yi-Jiun, additional, Gkitsas, Nikolaos, additional, Fowler, Carley, additional, Keerthi, Vimal, additional, Retherford, Aidan, additional, Klysz, Dorota, additional, Tunuguntla, Ramya, additional, Feldman, Steven, additional, Sahaf, Bita, additional, Baird, John H., additional, Muffly, Lori S., additional, Mackall, Crystal L., additional, Miklos, David B., additional, Good, Zinaida, additional, and Frank, Matthew J., additional

Published
2023
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46. Supplementary Figure S8 from Axicabtagene Ciloleucel in Combination with the 4–1BB Agonist Utomilumab in Patients with Relapsed/Refractory Large B-Cell Lymphoma: Phase 1 Results from ZUMA-11

Author

Jain, Michael D., primary, Miklos, David B., primary, Jacobson, Caron A., primary, Timmerman, John M., primary, Sun, Jennifer, primary, Nater, Jenny, primary, Fang, Xiang, primary, Patel, Ankit, primary, Davis, Madison, primary, Heeke, Darren, primary, Trinh, Tan, primary, Mattie, Mike, primary, Neumann, Frank, primary, Kim, Jenny J., primary, To, Christina, primary, Filosto, Simone, primary, and Reshef, Ran, primary

Published
2023
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47. Data from Axicabtagene Ciloleucel in Combination with the 4–1BB Agonist Utomilumab in Patients with Relapsed/Refractory Large B-Cell Lymphoma: Phase 1 Results from ZUMA-11

Author

Jain, Michael D., primary, Miklos, David B., primary, Jacobson, Caron A., primary, Timmerman, John M., primary, Sun, Jennifer, primary, Nater, Jenny, primary, Fang, Xiang, primary, Patel, Ankit, primary, Davis, Madison, primary, Heeke, Darren, primary, Trinh, Tan, primary, Mattie, Mike, primary, Neumann, Frank, primary, Kim, Jenny J., primary, To, Christina, primary, Filosto, Simone, primary, and Reshef, Ran, primary

Published
2023
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48. Supplementary Methods S1 from Axicabtagene Ciloleucel in Combination with the 4–1BB Agonist Utomilumab in Patients with Relapsed/Refractory Large B-Cell Lymphoma: Phase 1 Results from ZUMA-11

Author

Jain, Michael D., primary, Miklos, David B., primary, Jacobson, Caron A., primary, Timmerman, John M., primary, Sun, Jennifer, primary, Nater, Jenny, primary, Fang, Xiang, primary, Patel, Ankit, primary, Davis, Madison, primary, Heeke, Darren, primary, Trinh, Tan, primary, Mattie, Mike, primary, Neumann, Frank, primary, Kim, Jenny J., primary, To, Christina, primary, Filosto, Simone, primary, and Reshef, Ran, primary

Published
2023
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49. Supplementary Table S2 from Axicabtagene Ciloleucel in Combination with the 4–1BB Agonist Utomilumab in Patients with Relapsed/Refractory Large B-Cell Lymphoma: Phase 1 Results from ZUMA-11

Author

Jain, Michael D., primary, Miklos, David B., primary, Jacobson, Caron A., primary, Timmerman, John M., primary, Sun, Jennifer, primary, Nater, Jenny, primary, Fang, Xiang, primary, Patel, Ankit, primary, Davis, Madison, primary, Heeke, Darren, primary, Trinh, Tan, primary, Mattie, Mike, primary, Neumann, Frank, primary, Kim, Jenny J., primary, To, Christina, primary, Filosto, Simone, primary, and Reshef, Ran, primary

Published
2023
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50. ABO Mismatch Is Associated with Increased Nonrelapse Mortality after Allogeneic Hematopoietic Cell Transplantation

Author

Logan, Aaron C, Wang, Zhiyu, Alimoghaddam, Kamran, Wong, Ruby M, Lai, Tze, Negrin, Robert S, Grumet, Carl, Logan, Brent R, Zhang, Mei-Jie, Spellman, Stephen R, Lee, Stephanie J, Miklos, David B, and Transplantation, Center for International Blood and Marrow

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Clinical Research, Cancer, Transplantation, Hematology, Good Health and Well Being, ABO Blood-Group System, Adolescent, Adult, Aged, Allografts, Child, Child, Preschool, Disease-Free Survival, Female, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Infant, Male, Middle Aged, Retrospective Studies, Survival Rate, ABO mismatch, Allogeneic, Nonrelapse mortality, Center for International Blood and Marrow Transplantation, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

We evaluated ABO associated outcomes in 1737 patients who underwent allogeneic hematopoietic cell transplantation (allo-HCT) at Stanford University between January 1986 and July 2011. Grafts were 61% ABO matched, 18% major mismatched (MM), 17% minor MM, and 4% bidirectional MM. Median follow-up was 6 years. In multivariate analysis, overall survival (OS) was inferior in minor MM hematopoietic cell transplantations (median 2.1 versus 6.3 years; hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.19 to 2.05; P = .001) in comparison with ABO-matched grafts. ABO minor MM was associated with an increase in early nonrelapse mortality (NRM) (18% versus 13%; HR, 1.48; 95% CI, 1.06 to 2.06; P = .02). In an independent Center for International Blood and Marrow Transplant Research (CIBMTR) analysis of 435 lymphoma patients receiving mobilized peripheral blood grafts, impairment of OS (HR, 1.55; 95% CI, 1.07 to 2.25; P = .021) and increased NRM (HR, 1.72; 95% CI, 1.11 to 2.68; P = .03) were observed in recipients of ABO minor-MM grafts. A second independent analysis of a CIBMTR data set including 5179 patients with acute myeloid leukemia and myelodysplastic syndrome identified a nonsignificant trend toward decreased OS in recipients of ABO minor-MM grafts and also found ABO major MM to be significantly associated with decreased OS (HR, 1.19; 95% CI, 1.08 to 1.31; P < .001) and increased NRM (HR, 1.23; 95% CI, 1.08 to 1.4; P = .002). ABO minor and major MM are risk factors for worse transplantation outcomes, although the associated hazards may not be uniform across different transplantation populations. Further study is warranted to determine which patient populations are at greatest risk, and whether this risk can be modified by anti-B cell therapy or other peri-transplantation treatments.

Published
2015

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