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1,711 results on '"McGuirk, Joseph"'

1. Impact of extramedullary multiple myeloma on outcomes with idecabtagene vicleucel

Author

Zanwar, Saurabh, Sidana, Surbhi, Shune, Leyla, Puglianini, Omar Castaneda, Pasvolsky, Oren, Gonzalez, Rebecca, Dima, Danai, Afrough, Aimaz, Kaur, Gurbakhash, Davis, James A., Herr, Megan, Hashmi, Hamza, Forsberg, Peter, Sborov, Douglas, Anderson Jr, Larry D., McGuirk, Joseph P., Wagner, Charlotte, Lieberman-Cribbin, Alex, Rossi, Adriana, Freeman, Ciara L., Locke, Frederick L., Richard, Shambavi, Khouri, Jack, Lin, Yi, Patel, Krina K., Kumar, Shaji K., and Hansen, Doris K.

Published
2024
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2. Impact of Extraosseous Extramedullary Disease on Outcomes of Patients with Relapsed-Refractory Multiple Myeloma receiving Standard-of-Care Chimeric Antigen Receptor T-Cell Therapy

Author

Dima, Danai, Abdallah, Al-Ola, Davis, James A., Awada, Hussein, Goel, Utkarsh, Rashid, Aliya, DeJarnette, Shaun, Anwer, Faiz, Shune, Leyla, Raza, Shahzad, Mahmoudjafari, Zahra, Williams, Louis, Faiman, Beth, McGuirk, Joseph P., Sauter, Craig S., Ahmed, Nausheen, Khouri, Jack, and Hashmi, Hamza

Published
2024
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3. Real-world impact of bridging therapy on outcomes of ide-cel for myeloma in the U.S. Myeloma Immunotherapy Consortium

Author

Afrough, Aimaz, Hashmi, Hamza, Hansen, Doris K., Sidana, Surbhi, Ahn, Chul, Peres, Lauren C., Dima, Danai, Freeman, Ciara L., Puglianini, Omar Castaneda, Kocoglu, Mehmet H., Atrash, Shebli, Voorhees, Peter M., Shune, Leyla, McGuirk, Joseph P., Simmons, Gary, Sborov, Douglas W., Davis, James A., Kaur, Gurbakhash, Sannareddy, Aishwarya, Ferreri, Christopher J., Gaballa, Mahmoud R., Goldsmith, Scott, Nadeem, Omar, Midha, Shonali, Wagner, Charlotte B., Locke, Frederick L., Patel, Krina K., Khouri, Jack, Anderson, Jr., Larry D., and Lin, Yi

Published
2024
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4. Efficacy of checkpoint inhibition after CAR-T failure in aggressive B-cell lymphomas: outcomes from 15 US institutions

Author

Major, Ajay, Yu, Jovian, Shukla, Navika, Che, Yan, Karrison, Theodore G, Treitman, Rachel, Kamdar, Manali K, Haverkos, Bradley M, Godfrey, James, Babcook, Melissa A, Voorhees, Timothy J, Carlson, Sophie, Gaut, Daria, Oliai, Caspian, Romancik, Jason T, Winter, Allison M, Hill, Brian T, Bansal, Radhika, Bisneto, Jose C Villasboas, Nizamuddin, Imran A, Karmali, Reem, Fitzgerald, Lindsey A, Stephens, Deborah M, Pophali, Priyanka A, Trabolsi, Asaad, Schatz, Jonathan H, Hu, Marie, Bachanova, Veronika, Slade, Michael J, Singh, Nathan, Ahmed, Nausheen, McGuirk, Joseph P, Bishop, Michael R, Riedell, Peter A, and Kline, Justin

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Immunology, Clinical Research, Hematology, Rare Diseases, Lymphoma, Cancer, Biotechnology, Humans, Receptors, Chimeric Antigen, Retrospective Studies, Neoplasm Recurrence, Local, Lymphoma, Large B-Cell, Diffuse, Immunotherapy, Adoptive, Cardiovascular medicine and haematology
Abstract

Checkpoint inhibitor (CPI) therapy with anti-PD-1 antibodies has been associated with mixed outcomes in small cohorts of patients with relapsed aggressive B-cell lymphomas after CAR-T failure. To define CPI therapy efficacy more definitively in this population, we retrospectively evaluated clinical outcomes in a large cohort of 96 patients with aggressive B-cell lymphomas receiving CPI therapy after CAR-T failure across 15 US academic centers. Most patients (53%) had diffuse large B-cell lymphoma, were treated with axicabtagene ciloleucel (53%), relapsed early (≤180 days) after CAR-T (83%), and received pembrolizumab (49%) or nivolumab (43%). CPI therapy was associated with an overall response rate of 19% and a complete response rate of 10%. Median duration of response was 221 days. Median progression-free survival (PFS) and overall survival (OS) were 54 and 159 days, respectively. Outcomes to CPI therapy were significantly improved in patients with primary mediastinal B-cell lymphoma. PFS (128 vs 51 days) and OS (387 vs 131 days) were significantly longer in patients with late (>180 days) vs early (≤180 days) relapse after CAR-T. Grade ≥3 adverse events occurred in 19% of patients treated with CPI. Most patients (83%) died, commonly because of progressive disease. Only 5% had durable responses to CPI therapy. In the largest cohort of patients with aggressive B-cell lymphoma treated with CPI therapy after CAR-T relapse, our results reveal poor outcomes, particularly among those relapsing early after CAR-T. In conclusion, CPI therapy is not an effective salvage strategy for most patients after CAR-T, where alternative approaches are needed to improve post-CAR-T outcomes.

Published
2023

5. Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma in Standard-of-Care Practice: Results From the US Lymphoma CAR T Consortium.

Author

Wang, Yucai, Jain, Preetesh, Locke, Frederick, Maurer, Matthew, Frank, Matthew, Munoz, Javier, Dahiya, Saurabh, Beitinjaneh, Amer, Jacobs, Miriam, Mcguirk, Joseph, Vose, Julie, Goy, Andre, Hill, Brian, Dorritie, Kathleen, Oluwole, Olalekan, Deol, Abhinav, Paludo, Jonas, Shah, Bijal, Wang, Trent, Banerjee, Rahul, Miklos, David, Rapoport, Aaron, Lekakis, Lazaros, Ghobadi, Armin, Neelapu, Sattva, Lin, Yi, Wang, Michael, Jain, Michael, and Andreadis, Charalambos

Subjects
Adult, Humans, Receptors, Chimeric Antigen, Lymphoma, Mantle-Cell, Bendamustine Hydrochloride, Neoplasm Recurrence, Local, Immunotherapy, Adoptive, Lymphoma, Large B-Cell, Diffuse, Antigens, CD19
Abstract

PURPOSE: Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). This therapy was approved on the basis of the single-arm phase II ZUMA-2 trial, which showed best overall and complete response rates of 91% and 68%, respectively. We report clinical outcomes with brexu-cel in the standard-of-care setting for the approved indication. PATIENTS AND METHODS: Patients who underwent leukapheresis between August 1, 2020 and December 31, 2021, at 16 US institutions, with an intent to manufacture commercial brexu-cel for relapsed/refractory MCL, were included. Patient data were collected for analyses of responses, outcomes, and toxicities as per standard guidelines. RESULTS: Of 189 patients who underwent leukapheresis, 168 (89%) received brexu-cel infusion. Of leukapheresed patients, 79% would not have met ZUMA-2 eligibility criteria. Best overall and complete response rates were 90% and 82%, respectively. At a median follow-up of 14.3 months after infusion, the estimates for 6- and 12-month progression-free survival (PFS) were 69% (95% CI, 61 to 75) and 59% (95% CI, 51 to 66), respectively. The nonrelapse mortality was 9.1% at 1 year, primarily because of infections. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 8% and 32%, respectively. In univariable analysis, high-risk simplified MCL international prognostic index, high Ki-67, TP53 aberration, complex karyotype, and blastoid/pleomorphic variant were associated with shorter PFS after brexu-cel infusion. Patients with recent bendamustine exposure (within 24 months before leukapheresis) had shorter PFS and overall survival after leukapheresis in intention-to-treat univariable analysis. CONCLUSION: In the standard-of-care setting, the efficacy and toxicity of brexu-cel were consistent with those reported in the ZUMA-2 trial. Tumor-intrinsic features of MCL, and possibly recent bendamustine exposure, may be associated with inferior efficacy outcomes.

Published
2023

6. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.

Author

Lin, Chenyu, Schwarzbach, Aurelie, Sanz, Jaime, Montesinos, Pau, Stiff, Patrick, Parikh, Suhag, Brunstein, Claudio, Cutler, Corey, Lindemans, Caroline, Hanna, Rabi, Koh, Liang, Jagasia, Madan, Valcarcel, David, Maziarz, Richard, Keating, Amy, Hwang, William, Rezvani, Andrew, Karras, Nicole, Fernandes, Juliana, Rocha, Vanderson, Badell, Isabel, Ram, Ron, Schiller, Gary, Volodin, Leonid, Walters, Mark, Hamerschlak, Nelson, Cilloni, Daniela, Frankfurt, Olga, McGuirk, Joseph, Kurtzberg, Joanne, Sanz, Guillermo, Simantov, Ronit, and Horwitz, Mitchell

Subjects
Allogeneic stem cell transplantation, Clinical trial, Cord blood, Ex vivo expansion, Long-term follow-up, Humans, Follow-Up Studies, Prospective Studies, Hematopoietic Stem Cell Transplantation, Disease-Free Survival, Multicenter Studies as Topic
Abstract

Omidubicel is an umbilical cord blood (UCB)-derived ex vivo-expanded cellular therapy product that has demonstrated faster engraftment and fewer infections compared with unmanipulated UCB in allogeneic hematopoietic cell transplantation. Although the early benefits of omidubicel have been established, long-term outcomes remain unknown. We report on a planned pooled analysis of 5 multicenter clinical trials including 105 patients with hematologic malignancies or sickle cell hemoglobinopathy who underwent omidubicel transplantation at 26 academic transplantation centers worldwide. With a median follow-up of 22 months (range, .3 to 122 months), the 3-year estimated overall survival and disease-free survival were 62.5% and 54.0%, respectively. With up to 10 years of follow-up, omidubicel showed durable trilineage hematopoiesis. Serial quantitative assessments of CD3+, CD4+, CD8+, CD19+, CD116+CD56+, and CD123+ immune subsets revealed median counts remaining within normal ranges through up to 8 years of follow-up. Secondary graft failure occurred in 5 patients (5%) in the first year, with no late cases reported. One case of donor-derived myeloid neoplasm was reported at 40 months post-transplantation. This was also observed in a control arm patient who received only unmanipulated UCB. Overall, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up.

Published
2023

7. Favorable outcomes following CD34-selected stem cell boost for poor graft function after allogeneic hematopoietic stem cell transplantation

Author

Al-Ramahi, Joe S., Shahzad, Moazzam, Nguyen, Andrea, Li, Kevin, Amin, Muhammad Kashif, Ahmed, Nausheen, Lutfi, Forat, DeJarnette, Shaun, Chaudhary, Sibgha Gull, Bansal, Rajat, Abdelhakim, Haitham, Shune, Leyla, Abdallah, Al-Ola, Singh, Anurag K., Abhyankar, Sunil H., McGuirk, Joseph P., and Mushtaq, Muhammad Umair

Published
2024
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16. Predictors of cytomegalovirus reactivation after allogeneic hematopoietic cell transplantation: Insights from a real-world experience

Author

McGuirk, Matthew, Shahzad, Moazzam, Amin, Muhammad Kashif, Khan, Muhammad Atif, Bellman, Polina, Mudaranthakam, Dinesh Pal, DeJarnette, Shaun, Lutfi, Forat, Ahmed, Nausheen, Bansal, Rajat, Abdelhakim, Haitham, Gorsline, Chelsea, Shoemaker, Dennis Matthew, Abdallah, Al-Ola, Shune, Leyla, Abhyankar, Sunil H., Singh, Anurag K., McGuirk, Joseph P., and Mushtaq, Muhammad Umair

Published
2024
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17. Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy

Author

Ferreri, Christopher J., Hildebrandt, Michelle A. T., Hashmi, Hamza, Shune, Leyla O., McGuirk, Joseph P., Sborov, Douglas W., Wagner, Charlotte B., Kocoglu, M. Hakan, Rapoport, Aaron, Atrash, Shebli, Voorhees, Peter M., Khouri, Jack, Dima, Danai, Afrough, Aimaz, Kaur, Gurbakhash, Anderson, Jr., Larry D., Simmons, Gary, Davis, James A., Kalariya, Nilesh, Peres, Lauren C., Lin, Yi, Janakiram, Murali, Nadeem, Omar, Alsina, Melissa, Locke, Frederick L., Sidana, Surbhi, Hansen, Doris K., Patel, Krina K., and Castaneda Puglianini, Omar Alexis

Published
2023
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19. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update

Author

Dreyling, Martin, Fowler, Nathan Hale, Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, María Ferreri, Andrés José, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Paule, Ines, Zia, Aiesha, Awasthi, Rakesh, Han, Xia, Germano, Davide, O’Donovan, Darragh, Ramos, Roberto, Maier, Harald J., Masood, Aisha, Thieblemont, Catherine, and Schuster, Stephen J.

Published
2024
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22. Haploidentical vs. sibling, unrelated, or cord blood hematopoietic cell transplantation for acute lymphoblastic leukemia

Author

Wieduwilt, Matthew J, Metheny, Leland, Zhang, Mei-Jie, Wang, Hai-Lin, Estrada-Merly, Noel, Marks, David I, Al-Homsi, A Samar, Muffly, Lori, Chao, Nelson J, Rizzieri, David, Gale, Robert Peter, Gadalla, Shahinaz M, Cairo, Mitchell S, Mussetti, Alberto, Gore, Steven D, Bhatt, Vijaya Raj, Patel, Sagar S, Michelis, Fotios V, Inamoto, Yoshihiro, Badawy, Sherif M, Copelan, Edward, Palmisiano, Neil, Kharfan-Dabaja, Mohamed A, Lazarus, Hillard M, Ganguly, Siddhartha, Bredeson, Christopher N, Perez, Miguel Angel Diaz, Cassaday, Ryan, Savani, Bipin N, Ballen, Karen Kuhn, Martino, Rodrigo, Wirk, Baldeep, Bacher, Ulrike, Aljurf, Mahmoud, Bashey, Asad, Murthy, Hemant S, Yared, Jean A, Aldoss, Ibrahim, Farhadfar, Nosha, Liu, Hongtao, Abdel-Azim, Hisham, Waller, Edmund K, Solh, Melhem, Seftel, Matthew, van der Poel, Marjolein WM, Grunwald, Michael Richard, Liesveld, Jane L, Kamble, Rammurti T, McGuirk, Joseph P, Munker, Reinhold, Cahn, Jean-Yves, Lee, Jong Wook, Freytes, Cesar O, Krem, Maxwell, Winestone, Lena E, Gergis, Usama, Nathan, Sunita, Olsson, Richard F, Verdonck, Leo F, Sharma, Akshay, Ringden, Olle, Friend, Brian D, Cerny, Jan, Choe, Hannah K, Chhabra, Saurabh, Nishihori, Taiga, Seo, Sachiko, George, Biju, Baxter-Lowe, Lee Ann, Hildebrandt, Gerhard C, de Lima, Marcos, Litzow, Mark R, Kebriaei, Partow, Hourigan, Christopher S, Abid, Muhammad Bilal, Weisdorf, Daniel J, and Saber, Wael

Subjects
Rare Diseases, Cancer, Pediatric, Pediatric Cancer, Stem Cell Research - Nonembryonic - Human, Orphan Drug, Hematology, Stem Cell Research, Transplantation, Good Health and Well Being, Fetal Blood, Hematopoietic Stem Cell Transplantation, Humans, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Retrospective Studies, Siblings, Unrelated Donors
Abstract

The role of haploidentical hematopoietic cell transplantation (HCT) using posttransplant cyclophosphamide (PTCy) for acute lymphoblastic leukemia (ALL) is being defined. We performed a retrospective, multivariable analysis comparing outcomes of HCT approaches by donor for adults with ALL in remission. The primary objective was to compare overall survival (OS) among haploidentical HCTs using PTCy and HLA-matched sibling donor (MSD), 8/8 HLA-matched unrelated donor (MUD), 7 /8 HLA-MUD, or umbilical cord blood (UCB) HCT. Comparing haploidentical HCT to MSD HCT, we found that OS, leukemia-free survival (LFS), nonrelapse mortality (NRM), relapse, and acute graft-versus-host disease (aGVHD) were not different but chronic GVHD (cGVHD) was higher in MSD HCT. Compared with MUD HCT, OS, LFS, and relapse were not different, but MUD HCT had increased NRM (hazard ratio [HR], 1.42; P = .02), grade 3 to 4 aGVHD (HR, 1.59; P = .005), and cGVHD. Compared with 7/8 UD HCT, LFS and relapse were not different, but 7/8 UD HCT had worse OS (HR, 1.38; P = .01) and increased NRM (HR, 2.13; P ≤ .001), grade 3 to 4 aGVHD (HR, 1.86; P = .003), and cGVHD (HR, 1.72; P ≤ .001). Compared with UCB HCT, late OS, late LFS, relapse, and cGVHD were not different but UCB HCT had worse early OS (≤18 months; HR, 1.93; P < .001), worse early LFS (HR, 1.40; P = .007) and increased incidences of NRM (HR, 2.08; P < .001) and grade 3 to 4 aGVHD (HR, 1.97; P < .001). Haploidentical HCT using PTCy showed no difference in survival but less GVHD compared with traditional MSD and MUD HCT and is the preferred alternative donor HCT option for adults with ALL in complete remission.

Published
2022

23. An adapted European LeukemiaNet genetic risk stratification for acute myeloid leukemia patients undergoing allogeneic hematopoietic cell transplant. A CIBMTR analysis

Author

Jimenez Jimenez, Antonio M, De Lima, Marcos, Komanduri, Krishna V, Wang, Trent P, Zhang, Mei-Jie, Chen, Karen, Abdel-Azim, Hisham, Abid, Muhammad Bilal, Aljurf, Mahmoud, Alkhateeb, Hassan, Assal, Amer, Bacher, Ulrike, Baron, Frédéric, Battiwalla, Minoo, Beitinjaneh, Amer, Bejanyan, Nelli, Bhatt, Vijaya Raj, Byrne, Michael, Cahn, Jean-Yves, Cairo, Mitchell, Castillo, Paul, Copelan, Edward, DeFilipp, Zachariah, Perez, Miguel Angel Diaz, Elsawy, Mahmoud, Gale, Robert Peter, George, Biju, Grunwald, Michael R, Hildebrandt, Gerhard C, Hogan, William J, Kanakry, Christopher G, Kansagra, Ankit, Kharfan-Dabaja, Mohamed A, Khera, Nandita, Krem, Maxwell M, Lazaryan, Aleksandr, Maakaron, Joseph, Martino, Rodrigo, McGuirk, Joseph, Michelis, Fotios V, Milone, Giuseppe, Mishra, Asmita, Murthy, Hemant S, Mussetti, Alberto, Nathan, Sunita, Nishihori, Taiga, Olsson, Richard F, Palmisiano, Neil, Patel, Sagar, Saad, Ayman, Seo, Sachiko, Sharma, Akshay, Solh, Melhem, Verdonck, Leo F, Wirk, Baldeep, Yared, Jean A, Litzow, Mark, Kebriaei, Partow, Hourigan, Christopher S, Saber, Wael, and Weisdorf, Daniel

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Hematology, Genetics, Transplantation, Pediatric Research Initiative, Childhood Leukemia, Stem Cell Research, Cancer, Clinical Research, Pediatric Cancer, Rare Diseases, Pediatric, Stem Cell Research - Nonembryonic - Human, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Retrospective Studies, Risk Assessment, Transplantation Conditioning, Transplantation, Homologous, Clinical Sciences, Immunology, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

Cytogenetic and molecular abnormalities are known to influence post-transplant outcomes in acute myeloid leukemia (AML) but data assessing the prognostic value of combined genetic models in the HCT setting are limited. We developed an adapted European LeukemiaNet (aELN) risk classification based on available genetic data reported to the Center for International Blood and Marrow Transplant Research, to predict post-transplant outcomes in 2289 adult AML patients transplanted in first remission, between 2013 and 2017. Patients were stratified according to aELN into three groups: favorable (Fav, N = 181), intermediate (IM, N = 1185), and adverse (Adv, N = 923). Univariate analysis demonstrated significant differences in 2-year overall survival (OS) (Fav: 67.7%, IM: 64.9% and Adv: 53.9%; p

Published
2021

24. Bridging therapy with axicabtagene ciloleucel for large B-cell lymphoma: results from the US Lymphoma CAR-T Consortium

Author

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

Published
2024
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25. Racial and ethnic differences in clinical outcomes among patients with multiple myeloma treated with CAR T-cell therapy

Author

Peres, Lauren C., Oswald, Laura B., Dillard, Christen M., De Avila, Gabriel, Nishihori, Taiga, Blue, Brandon J., Freeman, Ciara L., Locke, Frederick L., Alsina, Melissa, Castaneda Puglianini, Omar, Shune, Leyla, Sborov, Douglas W., Wagner, Charlotte, Dima, Danai, Hashmi, Hamza, Davis, James A., Kocoglu, Mehmet H., Badros, Ashraf Z., Atrash, Shebli, Simmons, Gary, Kalariya, Nilesh, Ferreri, Christopher, Anderson, Larry D., Jr, Afrough, Aimaz, Kaur, Gurbakhash, Lin, Yi, Liu, Lawrence, Nadeem, Omar, Voorhees, Peter, Khouri, Jack, McGuirk, Joseph, Sidana, Surbhi, Hansen, Doris K., and Patel, Krina

Published
2024
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27. Safety and efficacy of standard-of-care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma

Author

Sidana, Surbhi, Patel, Krina K., Peres, Lauren C., Bansal, Radhika, Kocoglu, Mehmet H., Shune, Leyla, Atrash, Shebli, Smith, Kinaya, Midha, Shonali, Ferreri, Christopher, Dhakal, Binod, Dima, Danai, Costello, Patrick, Wagner, Charlotte, Reshef, Ran, Hosoya, Hitomi, Mikkilineni, Lekha, Atanackovic, Djordje, Chhabra, Saurabh, Parrondo, Ricardo, Nadeem, Omar, Mann, Hashim, Kalariya, Nilesh, Hovanky, Vanna, De Avila, Gabriel, Freeman, Ciara L., Locke, Frederick L., Alsina, Melissa, Wong, Sandy, Herr, Megan, Htut, Myo, McGuirk, Joseph, Sborov, Douglas W., Khouri, Jack, Martin, Thomas, Janakiram, Murali, Lin, Yi, and Hansen, Doris K.

Published
2024
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28. Impact of cytogenetic abnormalities on outcomes of adult Philadelphia-negative acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation: a study by the Acute Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research

Author

Lazaryan, Aleksandr, Dolan, Michelle, Zhang, Mei-Jie, Wang, Hai-Lin, Kharfan-Dabaja, Mohamed A, Marks, David I, Bejanyan, Nelli, Copelan, Edward, Majhail, Navneet S, Waller, Edmund K, Chao, Nelson, Prestidge, Tim, Nishihori, Taiga, Kebriaei, Partow, Inamoto, Yoshihiro, Hamilton, Betty, Hashmi, Shahrukh K, Kamble, Rammurti T, Bacher, Ulrike, Hildebrandt, Gerhard C, Stiff, Patrick J, McGuirk, Joseph, Aldoss, Ibrahim, Beitinjaneh, Amer M, Muffly, Lori, Vij, Ravi, Olsson, Richard F, Byrne, Michael, Schultz, Kirk R, Aljurf, Mahmoud, Seftel, Matthew, Savoie, Mary Lynn, Savani, Bipin N, Verdonck, Leo F, Cairo, Mitchell S, Hossain, Nasheed, Bhatt, Vijaya Raj, Frangoul, Haydar A, Abdel-Azim, Hisham, Al Malki, Monzr, Munker, Reinhold, Rizzieri, David, Khera, Nandita, Nakamura, Ryotaro, Ringdén, Olle, Van der Poel, Marjolein, Murthy, Hemant S, Liu, Hongtao, Mori, Shahram, De Oliveira, Satiro, Bolaños-Meade, Javier, Elsawy, Mahmoud, Barba, Pere, Nathan, Sunita, George, Biju, Pawarode, Attaphol, Grunwald, Michael, Agrawal, Vaibhav, Wang, Youjin, Assal, Amer, Caro, Paul Castillo, Kuwatsuka, Yachiyo, Seo, Sachiko, Ustun, Celalettin, Politikos, Ioannis, Lazarus, Hillard M, Saber, Wael, Sandmaier, Brenda M, De Lima, Marcos, Litzow, Mark, Bachanova, Veronika, and Weisdorf, Daniel

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cancer, Blood, Adult, Chromosome Aberrations, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

The authors inadvertently included grant numbers OT3HL147741 & U24CA233032, which are grant-specific. This was an oversight on the authors’ part as these grants did not support the research in this publication.

Published
2021

29. Identifying an optimal fludarabine exposure for improved outcomes after axi-cel therapy for aggressive B-cell non-Hodgkin lymphoma

Author

Scordo, Michael, Flynn, Jessica R., Gonen, Mithat, Devlin, Sean M., Parascondola, Allison, Tomas, Ana Alarcon, Shouval, Roni, Brower, Jamie, Porter, David L., Schuster, Stephen J., Bachanova, Veronika, Maakaron, Joseph, Maziarz, Richard T., Chen, Andy I., Nastoupil, Loretta J., McGuirk, Joseph P., Oluwole, Olalekan O., Ip, Andrew, Leslie, Lori A., Bishop, Michael R., Riedell, Peter A., and Perales, Miguel-Angel

Published
2023
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35. Optimal Donor for African Americans with Hematologic Malignancy: HLA-Haploidentical Relative or Umbilical Cord Blood Transplant

Author

Solomon, Scott R, Martin, Andrew St, Zhang, Mei-Jie, Ballen, Karen, Bashey, Asad, Battiwalla, Minoo, Baxter-Lowe, Lee Ann, Brunstein, Claudio, Chhabra, Saurabh, Perez, Miguel Angel Diaz, Fuchs, Ephraim J, Ganguly, Siddhartha, Hardy, Nancy, Hematti, Peiman, McGuirk, Joseph, Peres, Edward, Ringden, Olle, Rizzieri, David, Romee, Rizwan, Solh, Melhem, Szwajcer, David, van der Poel, Marjolein, Waller, Edmund, William, Basem M, and Eapen, Mary

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Stem Cell Research, Stem Cell Research - Nonembryonic - Human, Clinical Research, Transplantation, Hematology, Stem Cell Research - Umbilical Cord Blood/ Placenta - Human, Rare Diseases, Cancer, Regenerative Medicine, Stem Cell Research - Umbilical Cord Blood/ Placenta, Good Health and Well Being, Black or African American, Cord Blood Stem Cell Transplantation, Fetal Blood, Graft vs Host Disease, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Histocompatibility Testing, Humans, Alternative donor, African American, Caucasian, race, leukemia, transplant-related mortality, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

Although hematopoietic cell transplantation from an HLA-matched unrelated donor is potentially curative for hematologic malignancies, survival is lower for African Americans compared with Caucasians. Because only approximately 20% of African Americans will have an HLA-matched unrelated donor, many of these patients undergo HLA-haploidentical relative or umbilical cord blood transplantation. In this study, we analyzed outcomes after HLA-haploidentical related donor (n = 249) and umbilical cord blood (n = 118) transplantations in African American patients with hematologic malignancy between 2008 and 2016. The predominant disease was acute myelogenous leukemia for recipients of both types of donor grafts. The incidences of grade II-IV and III-IV acute graft-versus-host disease were higher after umbilical cord blood transplantation compared with HLA-haploidentical relative transplantation (56% and 29%, respectively, versus 33% and 11%, respectively; P < .0001). The 2-year incidence of transplantation-related mortality adjusted for age and conditioning regimen intensity was higher after umbilical cord blood transplantation compared with HLA-haploidentical related donor transplantation (31% versus 18%; P = .008); however, there were no between-group differences in the 2-year adjusted incidence of relapse (30% versus 34%; P = .51), overall survival (54% versus 57%; P = .66), or disease-free survival (43% versus 47%; P = .46). Our findings show that the use of HLA-haploidentical and umbilical cord blood transplants expands the access to transplantation with comparable leukemia-free and overall survival for African Americans with hematologic malignancies.

Published
2020

36. 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

37. Impact of cytogenetic abnormalities on outcomes of adult Philadelphia-negative acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation: a study by the Acute Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research

Author

Lazaryan, Aleksandr, Dolan, Michelle, Zhang, Mei-Jie, Wang, Hai-Lin, Kharfan-Dabaja, Mohamed A, Marks, David I, Bejanyan, Nelli, Copelan, Edward, Majhail, Navneet S, Waller, Edmund K, Chao, Nelson, Prestidge, Tim, Nishihori, Taiga, Kebriaei, Partow, Inamoto, Yoshihiro, Hamilton, Betty, Hashmi, Shahrukh K, Kamble, Rammurti T, Bacher, Ulrike, Hildebrandt, Gerhard C, Stiff, Patrick J, McGuirk, Joseph, Aldoss, Ibrahim, Beitinjaneh, Amer M, Muffly, Lori, Vij, Ravi, Olsson, Richard F, Byrne, Michael, Schultz, Kirk R, Aljurf, Mahmoud, Seftel, Matthew, Savoie, Mary Lynn, Savani, Bipin N, Verdonck, Leo F, Cairo, Mitchell S, Hossain, Nasheed, Bhatt, Vijaya Raj, Frangoul, Haydar A, Abdel-Azim, Hisham, Malki, Monzr Al, Munker, Reinhold, Rizzieri, David, Khera, Nandita, Nakamura, Ryotaro, Ringdén, Olle, van der Poel, Marjolein, Murthy, Hemant S, Liu, Hongtao, Mori, Shahram, De Oliveira, Satiro, Bolaños-Meade, Javier, Elsawy, Mahmoud, Barba, Pere, Nathan, Sunita, George, Biju, Pawarode, Attaphol, Grunwald, Michael, Agrawal, Vaibhav, Wang, Youjin, Assal, Amer, Caro, Paul Castillo, Kuwatsuka, Yachiyo, Seo, Sachiko, Ustun, Celalettin, Politikos, Ioannis, Lazarus, Hillard M, Saber, Wael, Sandmaier, Brenda M, De Lima, Marcos, Litzow, Mark, Bachanova, Veronika, Weisdorf, Daniel, and Committee of the CIBMTR, Acute Leukemia

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Pediatric Cancer, Transplantation, Childhood Leukemia, Hematology, Cancer, Pediatric, Stem Cell Research, Adult, Chromosome Aberrations, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Retrospective Studies, Transplantation Conditioning, Transplantation, Homologous, Acute Leukemia Committee of the CIBMTR, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Cytogenetic risk stratification at diagnosis has long been one of the most useful tools to assess prognosis in acute lymphoblastic leukemia (ALL). To examine the prognostic impact of cytogenetic abnormalities on outcomes after allogeneic hematopoietic cell transplantation, we studied 1731 adults with Philadelphia-negative ALL in complete remission who underwent myeloablative or reduced intensity/non-myeloablative conditioning transplant from unrelated or matched sibling donors reported to the Center for International Blood and Marrow Transplant Research. A total of 632 patients had abnormal conventional metaphase cytogenetics. The leukemia-free survival and overall survival rates at 5 years after transplantation in patients with abnormal cytogenetics were 40% and 42%, respectively, which were similar to those in patients with a normal karyotype. Of the previously established cytogenetic risk classifications, modified Medical Research Council-Eastern Cooperative Oncology Group score was the only independent prognosticator of leukemia-free survival (P=0.03). In the multivariable analysis, monosomy 7 predicted post-transplant relapse [hazard ratio (HR)=2.11; 95% confidence interval (95% CI): 1.04-4.27] and treatment failure (HR=1.97; 95% CI: 1.20-3.24). Complex karyotype was prognostic for relapse (HR=1.69; 95% CI: 1.06-2.69), whereas t(8;14) predicted treatment failure (HR=2.85; 95% CI: 1.35-6.02) and overall mortality (HR=3.03; 95% CI: 1.44-6.41). This large study suggested a novel transplant-specific cytogenetic scheme with adverse [monosomy 7, complex karyotype, del(7q), t(8;14), t(11;19), del(11q), tetraploidy/near triploidy], intermediate (normal karyotype and all other abnormalities), and favorable (high hyperdiploidy) risks to prognosticate leukemia-free survival (P=0.02). Although some previously established high-risk Philadelphia-negative cytogenetic abnormalities in ALL can be overcome by transplantation, monosomy 7, complex karyotype, and t(8;14) continue to pose significant risks and yield inferior outcomes.

Published
2020

38. SARS-CoV-2 vaccination in the first year after allogeneic hematopoietic cell transplant: a prospective, multicentre, observational study

Author

Hill, Joshua A., Martens, Michael J., Young, Jo-Anne H., Bhavsar, Kavita, Kou, Jianqun, Chen, Min, Lee, Lik Wee, Baluch, Aliyah, Dhodapkar, Madhav V., Nakamura, Ryotaro, Peyton, Kristin, Shahid, Zainab, Armistead, Paul, Westervelt, Peter, McCarty, John, McGuirk, Joseph, Hamadani, Mehdi, DeWolf, Susan, Hosszu, Kinga, Sharon, Elad, Spahn, Ashley, Toor, Amir A., Waldvogel, Stephanie, Greenberger, Lee M., Auletta, Jeffery J., Horowitz, Mary M., Riches, Marcie L., and Perales, Miguel-Angel

Published
2023
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39. Outcomes of Tyrosine Kinase Inhibitors Maintenance Therapy with or without Allogeneic Hematopoietic Stem Cell Transplantation in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in First Complete Remission: A Systematic Review and Meta-Analysis

Author

Shahzad, Moazzam, Hussain, Ali, Tariq, Ezza, Anwar, Iqra, Faisal, Muhammad S., Syed, Leena, Karam, Alvina, Chaudhary, Sibgha Gull, Ahmed, Nausheen, Bansal, Rajat, Khurana, Sharad, Singh, Anurag K., Byrd, Kenneth P., Hematti, Peiman, Abhyankar, Sunil H., McGuirk, Joseph P., and Mushtaq, Muhammad Umair

Published
2023
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40. Imaging Biomarkers to Predict Outcomes in Patients With Large B-Cell Lymphoma With a Day 28 Partial Response by 18F-FDG PET/CT Imaging Following CAR-T Therapy

Author

Lutfi, Forat, Goloubeva, Olga, Kowatli, Amer, Gryaznov, Anton, Kim, Dong W, Dureja, Rohan, Margiotta, Philip, Matsumoto, Lisa R, Bukhari, Ali, Ahmed, Nausheen, Mushtaq, Muhammad Umair, Law, Jennie Y., Lee, Seung T., Kocoglu, Mehmet H., Atanackovic, Djordje, Yared, Jean A., Hardy, Nancy M., McGuirk, Joseph P., Rapoport, Aaron P., Chen, Wengen, and Dahiya, Saurabh

Published
2023
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42. Comparison of biosimilar filgrastim and originator filgrastim for peripheral blood stem cell mobilization for allogeneic hematopoietic stem cell transplantation

Author

Shahzad, Moazzam, primary, Amin, Muhammad Kashif, additional, Bellman, Polina, additional, Al‐Ramahi, Joe, additional, Noor, Jawad, additional, Vyas, Abhinav, additional, Mahmoudjafari, Zahra, additional, McGuirk, Matthew, additional, DeJarnette, Shaun, additional, Ahmed, Nausheen, additional, Abdallah, Al‐Ola, additional, Shune, Leyla, additional, Singh, Anurag K., additional, McGuirk, Joseph P., additional, Abhyankar, Sunil, additional, and Mushtaq, Muhammad Umair, additional

Published
2024
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43. Characterizing clinical trials for CAR T targeting solid tumors from 2018 to 2023: A systematic review.

Author

Wesson, William, primary, Ayoobkhan, Fathima Shehnaz, additional, Mahmoudjafari, Zahra, additional, Mushtaq, Muhammad Umair, additional, Abdallah, Al-Ola A., additional, Sun, Weijing, additional, Anwer, Faiz, additional, Doolittle, Gary C., additional, McGuirk, Joseph, additional, Al-Rajabi, Raed Moh'd Taiseer, additional, Baranda, Joaquina Celebre, additional, and Ahmed, Nausheen, additional

Published
2024
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44. Impact of late immune effector cell associated hematotoxicity (ICAHT) and prolonged neutropenia after CAR-T therapy on infection and survival outcomes.

Author

Zenner, Morgan, primary, Lessans, Spencer, additional, Rejeski, Kai, additional, Perales, Miguel-Angel, additional, Maziarz, Richard T., additional, Chen, Andy I., additional, Porter, David L., additional, Schuster, Stephen J., additional, McGuirk, Joseph, additional, Bishop, Michael Russell, additional, Bachanova, Veronika, additional, Nastoupil, Loretta J., additional, Riedell, Peter A., additional, Oluwole, Olalekan O., additional, Bhaskar, Shakthi, additional, and Patel, Vivek, additional

Published
2024
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45. Neurocognitive testing to predict ICANS post-CAR T.

Author

Wesson, William, primary, Scott, Lauren, additional, Suleman, Nahid, additional, DeJarnette, Shaun, additional, Abdallah, Al-Ola A., additional, Lutfi, Forat Umair, additional, Abhyankar, Sunil H., additional, Shune, Leyla, additional, Mushtaq, Muhammad Umair, additional, Singh, Anurag Kumar, additional, Abdelhakim, Haitham, additional, McGuirk, Joseph, additional, Nashatizadeh, Muhammad, additional, Muenks, Elizabeth M, additional, Katz, Hannah, additional, and Ahmed, Nausheen, additional

Published
2024
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47. Prospective longitudinal study of kinetics of humoral response to one, two, or three doses of SARS-CoV-2 vaccine in hematopoietic cell transplant recipients

Author

Khan, Qamar J., Bivona, Cory R., Liu, Ben, Nelson, Maggie, Martin, Grace A., Mushtaq, Muhammad Umair, Sharma, Priyanka, Streeter, Natalie R., Hoffmann, Marc, Doolittle, Gary C., Zhong, Cuncong, Mitchell, Laura, Li, Kevin H., Pessetto, Ziyan Y., Ghosh, Arnab, Pathak, Harsh B., Zhang, Jun, Godwin, Andrew K., and McGuirk, Joseph P.

Published
2022
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50. Myeloablative vs reduced intensity T-cell-replete haploidentical transplantation for hematologic malignancy.

Author

Solomon, Scott, St Martin, Andrew, Shah, Nirav, Fatobene, Giancarlo, Al Malki, Monzr, Ballen, Karen, Bashey, Asad, Bejanyan, Nelli, Bolaños Meade, Javier, Brunstein, Claudio, DeFilipp, Zachariah, Champlin, Richard, Fuchs, Ephraim, Hamadani, Mehdi, Hematti, Peiman, Kanakry, Christopher, McGuirk, Joseph, McNiece, Ian, Ciurea, Stefan, Pasquini, Marcelo, Rocha, Vanderson, Romee, Rizwan, Patel, Sagar, Vasu, Sumithira, Waller, Edmund, Wingard, John, Zhang, Mei-Jie, and Eapen, Mary

Subjects
Adolescent, Adult, Disease-Free Survival, Female, Hematologic Neoplasms, Humans, Middle Aged, Myeloablative Agonists, Transplantation Conditioning, Transplantation, Haploidentical, Young Adult
Abstract

In the absence of prospective studies that examine the effect of conditioning regimen intensity after T-cell-replete haploidentical transplant for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS), a retrospective cohort analysis was performed. Of the 1325 eligible patients (AML, n = 818; ALL, n = 286; and MDS, n = 221), 526 patients received a myeloablative regimen and 799 received a reduced-intensity regimen. Graft-versus-host disease prophylaxis was uniform with posttransplant cyclophosphamide, a calcineurin inhibitor, and mycophenolate mofetil. The primary end point was disease-free survival. Cox regression models were built to study the effect of conditioning regimen intensity on transplant outcomes. For patients aged 18 to 54 years, disease-free survival was lower (hazard ratio [HR], 1.34; 42% vs 51%; P = .007) and relapse was higher (HR, 1.51; 44% vs 33%; P = .001) with a reduced-intensity regimen compared with a myeloablative regimen. Nonrelapse mortality did not differ according to regimen intensity. For patients aged 55 to 70 years, disease-free survival (HR, 0.97; 37% vs 43%; P = .83) and relapse (HR, 1.32; 42% vs 31%; P = .11) did not differ according to regimen intensity. Nonrelapse mortality was lower with reduced-intensity regimens (HR, 0.64; 20% vs 31%; P = .02). Myeloablative regimens are preferred for AML, ALL, and MDS; reduced-intensity regimens should be reserved for those unable to tolerate myeloablation.

Published
2019

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