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1. 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

3. Risk Factors for Graft-versus-Host Disease in Haploidentical Hematopoietic Cell Transplantation Using Post-Transplant Cyclophosphamide.

Author

Im, Annie, Rashidi, Armin, Wang, Tao, Hemmer, Michael, MacMillan, Margaret, Pidala, Joseph, Jagasia, Madan, Pavletic, Steven, Majhail, Navneet, Weisdorf, Daniel, Abdel-Azim, Hisham, Agrawal, Vaibhav, Al-Homsi, A, Aljurf, Mahmoud, Askar, Medhat, Auletta, Jeffery, Bashey, Asad, Beitinjaneh, Amer, Bhatt, Vijaya, Byrne, Michael, Cahn, Jean-Yves, Cairo, Mitchell, Castillo, Paul, Cerny, Jan, Chhabra, Saurabh, Choe, Hannah, Ciurea, Stefan, Daly, Andrew, Perez, Miguel, Farhadfar, Nosha, Gadalla, Shahinaz, Gale, Robert, Ganguly, Siddhartha, Gergis, Usama, Hanna, Rabi, Hematti, Peiman, Herzig, Roger, Hildebrandt, Gerhard, Lad, Deepesh, Lee, Catherine, Lehmann, Leslie, Lekakis, Lazaros, Kamble, Rammurti, Kharfan-Dabaja, Mohamed, Khandelwal, Pooja, Martino, Rodrigo, Murthy, Hemant, Nishihori, Taiga, OBrien, Tracey, Olsson, Richard, Patel, Sagar, Perales, Miguel-Angel, Prestidge, Tim, Qayed, Muna, Romee, Rizwan, Schoemans, Hélène, Seo, Sachiko, Sharma, Akshay, Solh, Melhem, Strair, Roger, Teshima, Takanori, Urbano-Ispizua, Alvaro, Van der Poel, Marjolein, Vij, Ravi, Wagner, John, William, Basem, Wirk, Baldeep, Yared, Jean, Spellman, Steve, Arora, Mukta, and Hamilton, Betty

Subjects
Adult, Cyclophosphamide, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Risk Factors, Transplantation Conditioning
Abstract

Post-transplant cyclophosphamide (PTCy) has significantly increased the successful use of haploidentical donors with a relatively low incidence of graft-versus-host disease (GVHD). Given its increasing use, we sought to determine risk factors for GVHD after haploidentical hematopoietic cell transplantation (haplo-HCT) using PTCy. Data from the Center for International Blood and Marrow Transplant Research on adult patients with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myeloid leukemia who underwent PTCy-based haplo-HCT (2013 to 2016) were analyzed and categorized into 4 groups based on myeloablative (MA) or reduced-intensity conditioning (RIC) and bone marrow (BM) or peripheral blood (PB) graft source. In total, 646 patients were identified (MA-BM = 79, MA-PB = 183, RIC-BM = 192, RIC-PB = 192). The incidence of grade 2 to 4 acute GVHD at 6 months was highest in MA-PB (44%), followed by RIC-PB (36%), MA-BM (36%), and RIC-BM (30%) (P = .002). The incidence of chronic GVHD at 1 year was 40%, 34%, 24%, and 20%, respectively (P < .001). In multivariable analysis, there was no impact of stem cell source or conditioning regimen on grade 2 to 4 acute GVHD; however, older donor age (30 to 49 versus

Published
2020

4. A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease

Author

Schroeder, Mark A, Khoury, H Jean, Jagasia, Madan, Ali, Haris, Schiller, Gary J, Staser, Karl, Choi, Jaebok, Gehrs, Leah, Arbushites, Michael C, Yan, Ying, Langmuir, Peter, Srinivas, Nithya, Pratta, Michael, Perales, Miguel-Angel, Chen, Yi-Bin, Meyers, Gabrielle, and DiPersio, John F

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Stem Cell Research - Nonembryonic - Human, Hematology, Clinical Trials and Supportive Activities, Stem Cell Research, Rare Diseases, Orphan Drug, Clinical Research, Transplantation, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adolescent, Adrenal Cortex Hormones, Adult, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Janus Kinase 1, Protein Kinase Inhibitors, Steroids, Cardiovascular medicine and haematology
Abstract

Acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic cell transplantation (HCT) is a primary cause of nonrelapse mortality and a major barrier to successful transplant outcomes. Itacitinib is a Janus kinase (JAK)1-selective inhibitor that has demonstrated efficacy in preclinical models of aGVHD. We report results from the first registered study of a JAK inhibitor in patients with aGVHD. This was an open-label phase 1 study enrolling patients aged ≥18 years with first HCT from any source who developed grade IIB to IVD aGVHD. Patients with steroid-naive or steroid-refractory aGVHD were randomized 1:1 to itacitinib 200 mg or 300 mg once daily plus corticosteroids. The primary endpoint was safety and tolerability; day 28 overall response rate (ORR) was the main secondary endpoint. Twenty-nine patients (200 mg, n = 14; 300 mg, n = 15) received ≥1 dose of itacitinib and were included in safety and efficacy assessments. One dose-limiting toxicity was reported (grade 3 thrombocytopenia attributed to GVHD progression in a patient receiving 300 mg itacitinib with preexisting thrombocytopenia). The most common nonhematologic treatment-emergent adverse event was diarrhea (48.3%, n = 14); anemia occurred in 11 patients (38%). ORR on day 28 for all patients in the 200-mg and 300-mg groups was 78.6% and 66.7%, respectively. Day 28 ORR was 75.0% for patients with treatment-naive aGVHD and 70.6% in those with steroid-refractory aGVHD. All patients receiving itacitinib decreased corticosteroid use over time. In summary, itacitinib was well tolerated and demonstrated encouraging efficacy in patients with steroid-naive or steroid-refractory aGVHD, warranting continued clinical investigations. This trial was registered at www.clinicaltrials.gov as #NCT02614612.

Published
2020

5. Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies

Author

Nikiforow, Sarah, Frigault, Matthew J., Frey, Noelle V., Gardner, Rebecca A., Komanduri, Krishna V., Perales, Miguel-Angel, Kebriaei, Partow, Warkentin, Phyllis Irene, Pasquini, Marcelo, Aho, Joy Lynn, Levine, Bruce L., Heslop, Helen E., Hlucky, Tracey L., Habucky, Karen, Gharibo, Mecide, Jagasia, Madan, and Locke, Frederick L.

Published
2023
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6. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma.

Author

Cornell, Robert, Ky, Bonnie, Weiss, Brendan, Dahm, Cherie, Gupta, Deepak, Du, Liping, Carver, Joseph, Cohen, Adam, Engelhardt, Brian, Garfall, Alfred, Goodman, Stacey, Harrell, Shelton, Kassim, Adetola, Jadhav, Trafina, Jagasia, Madan, Moslehi, Javid, OQuinn, Rupal, Savona, Michael, Slosky, David, Smith, Amanda, Stadtmauer, Edward, Vogl, Dan, Waxman, Adam, and Lenihan, Daniel

Subjects
Adult, Aged, Aged, 80 and over, Bortezomib, Cardiovascular Diseases, Disease-Free Survival, Electrocardiography, Female, Heart Diseases, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Molecular Targeted Therapy, Multiple Myeloma, Natriuretic Peptide, Brain, Neoplasm Recurrence, Local, Oligopeptides, Prospective Studies, Proteasome Inhibitors, Risk Factors, Time-to-Treatment, Treatment Outcome, Troponin I, Troponin T
Abstract

PURPOSE: Cardiovascular adverse events (CVAEs) can occur during proteasome inhibitor (PI) therapy. We conducted a prospective, observational, multi-institutional study to define risk factors and outcomes in patients with multiple myeloma (MM) receiving PIs. PATIENTS AND METHODS: Patients with relapsed MM initiating carfilzomib- or bortezomib-based therapy underwent baseline assessments and repeated assessments at regular intervals over 6 months, including cardiac biomarkers (troponin I or T, brain natriuretic peptide [BNP], and N-terminal proBNP), ECG, and echocardiography. Monitoring occurred over 18 months for development of CVAEs. RESULTS: Of 95 patients enrolled, 65 received carfilzomib and 30 received bortezomib, with median 25 months of follow-up. Sixty-four CVAEs occurred, with 55% grade 3 or greater in severity. CVAEs occurred in 51% of patients treated with carfilzomib and 17% of those treated with bortezomib (P = .002). Median time to first CVAE from treatment start was 31 days, and 86% occurred within the first 3 months. Patients receiving carfilzomib-based therapy with a baseline elevated BNP level higher than 100 pg/mL or N-terminal proBNP level higher than 125 pg/mL had increased risk for CVAE (odds ratio, 10.8; P < .001). Elevated natriuretic peptides occurring mid-first cycle of treatment with carfilzomib were associated with a substantially higher risk of CVAEs (odds ratio, 36.0; P < .001). Patients who experienced a CVAE had inferior progression-free survival (log-rank P = .01) and overall survival (log-rank P < .001). PI therapy was safely resumed in 89% of patients, although 41% required chemotherapy modifications. CONCLUSION: CVAEs are common during PI therapy for relapsed MM, especially with carfilzomib, particularly within the first 3 months of therapy. CVAEs were associated with worse overall outcomes, but usually, discontinuation of therapy was not required. Natriuretic peptides were highly predictive of CVAEs; however, validation of this finding is necessary before uniform incorporation into the routine management of patients receiving carfilzomib.

Published
2019

7. Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy.

Author

Cornell, Robert, Goldhaber, Samuel, Engelhardt, Brian, Moslehi, Javid, Jagasia, Madan, Patton, Daryl, Harrell, Shelton, Hall, Robert, Wyatt, Houston, and Piazza, Greg

Subjects
Apixaban (Eliquis®), anticoagulation (AC), immunomodualtors, myeloma, venous thomboembolism
Abstract

Immunomodulatory drugs (IMiDs), including thalidomide, lenalidomide, and pomalidomide, have improved survival of patients with multiple myeloma (MM). However, these therapies are associated with an increased risk of venous thromboembolism (VTE). Apixaban has been approved for treatment of acute VTE and for risk reduction of recurrent VTE following initial therapy. In this phase IV single-arm study (NCT02958969), we aim to prospectively evaluate the safety and efficacy of apixaban for primary prevention of VTE in patients with MM. The primary efficacy objective of this trial is to determine the rate of symptomatic VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), over 6 months. The primary safety objective is to determine the rate of major bleeding in MM patients receiving apixaban prophylaxis. If proven safe and effective, apixaban will emerge as a promising option for oral VTE prophylaxis in MM patients.

Published
2019

8. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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11. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report

Author

Pidala, Joseph, Kitko, Carrie, Lee, Stephanie J., Carpenter, Paul, Cuvelier, Geoffrey D.E., Holtan, Shernan, Flowers, Mary E., Cutler, Corey, Jagasia, Madan, Gooley, Ted, Palmer, Joycelynne, Randolph, Tim, Levine, John E., Ayuk, Francis, Dignan, Fiona, Schoemans, Helene, Tkaczyk, Eric, Farhadfar, Nosha, Lawitschka, Anita, Schultz, Kirk R., Martin, Paul J., Sarantopoulos, Stefanie, Inamoto, Yoshihiro, Socie, Gerard, Wolff, Daniel, Blazar, Bruce, Greinix, Hildegard, Paczesny, Sophie, Pavletic, Steven, and Hill, Geoffrey

Published
2021
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20. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Abildgaard, Niels, Adler, Howard, Altuntas, Fevzi, Akay, Olga Meltem, Amin, Bipinkumar, Anagnostopoulos, Achilleas, Anderson, Larry, Anttila, Pekka, Araujo, Carla, Arce-Lara, Carlos, Aydin, Yildiz, Basu, Supratik, Battini, Ramakrishna, Beeker, Thaddeus, Benboubker, Lotfi, Ben-Yehuda, Dina, Bladé, Joan, Blau, Igor Wolfgang, Boccia, Ralph, Burke, Lillian, Byeff, Peter, Cascavilla, Nicola, Cavo, Michele, Chantry, Andrew, Charles, Yen, Chaudhry, Arvind, Corso, Alessandro, Coyne, Mark, De Arriba, Felipe, Delimpasi, Sosana, Desjardins, Pierre, Dhakal, Binod, Di Bartolomeo, Paolo, Di Raimondo, Francesco, Dürig, Jan, Engelhardt, Monika, Escoffre-Barbe, Martine, Esteves, Graca, Flogegard, Max, Gabrail, Nashat, Gamberi, Barbara, Garrison, Mitchell, Gay, Julie, Gisslinger, Heinz, Goldschmidt, Hartmut, Goncalves, Cristina, Gressot, Laurent, Grosicki, Sebastian, Hanna, Wahid, Hayden, Patrick, Henriques Bernardo, Maria Manuela, Hermann, Robert, Holden, Viran, Honkalehto, Kirsti, Huben, Marianne, Huffman, John, Hunter, Hannah, Hus, Marek, Jagasia, Madan, Jagganath, Sundar, Janakiram, Murali, Jaiyesimi, Ishmael, Jenner, Matthew, João, Cristina, Johnson, Peter, Jurcyszyn, Artur, Kalayoğlu Beşişik, Sevgi, Kambhampati, Suman, Kanate, Abraham, Karadoğan, Ihsan, Khojasteh, Ali, Kirkel, Dean, Komarnicki, Mieczyslaw, Krauth, Maria-Theresa, Kuriakose, Phillip, Larocca, Alessandra, Lauri, Birgitta, Leleu, Xavier, Lucio, Paulo, Luppi, Mario, Mangiacavalli, Silvia, Mariette, Clara, Matsue, Kosei, Mellqvist, Ulf-Henri, Mendeleeva, Larisa, Meshad, Michael, Miller, Carole, Mohrbacher, Ann, Moreau, Philippe, Morelli, Anna Maria, Müldür, Ercan, Naassan, Anthony, Nahi, Hareth, Nair, Rajesh, O'Dwyer, Mike, Öngören Aydin, Seniz, Openshaw, Thomas, O'Rourke, Timothy, Osswald, Michael, Overton, Lindsay, Pati, Asmin, Pavic, Michel, Pegourie, Brigitte, Pehlivan, Mustafa, Pierola, Ana Alfonso, Plesner, Torben, Pluta, Andrzej, Rabin, Neil, Ramasamy, Karthik, Rambaldi, Alessandro, Rodriguez, Paula, Röllig, Christoph, Rosenblatt, Jacalyn, Rosenbluth, Jonathan, Salomo, Morten, Samoylova, Olga, Sastre Moral, Jose, Sati, Hamdi, Selleri, Carmine, Shafeek, Salim, Shinagawa, Atsushi, Sleckman, Bethany, Smith, Clay, Sonmez, Mehmet, Stone, Chester, Streetly, Matthew, Suzuki, Kenshi, Taetle, Raymond, Tafuri, Agostino, Takezako, Naoki, Teke, Hava Üsküdar, Vapaatalo, Mirja, Vassilopoulos, George, Verma, Amit, Vidito, Sarah, Viterbo, Luisa, Vural, Filiz, Wang, Xiang Sean, Yağci, Munci, Yee, Andrew, Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, and Dimopoulos, Meletios

Published
2019
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21. CT-314 Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation With Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials

Author

Lin, Chenyu, Schwarzbach, Aurelie, Montesinos, Pau, Stiff, Patrick, Cutler, Corey, Parikh, Suhag, Brunstein, Claudio, Lindemans, Caroline A., Hanna, Rabi, Koh, Liang Piu, Maziarz, Richard T., Keating, Amy K., Huang, William Y.K., Rezvani, Andrew R., Valcarcel, David, Fernandes, Juliana F., Badell, Isabell S., Jagasia, Madan H., Frankfurt, Olga, Ram, Ron, McGuirk, Joseph P., Kurtzberg, Joanne, Sanz, Guillermo, Simantov, Ronit, and Horwitz, Mitchell E.

Published
2022
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28. Chronic Myelogenous Leukemia, Version 1.2014.

Author

O'Brien, Susan, Radich, Jerald P, Abboud, Camille N, Akhtari, Mojtaba, Altman, Jessica K, Berman, Ellin, DeAngelo, Daniel J, Deininger, Michael, Devine, Steven, Fathi, Amir T, Gotlib, Jason, Jagasia, Madan, Kropf, Patricia, Moore, Joseph O, Pallera, Arnel, Pinilla-Ibarz, Javier, Reddy, Vishnu Vb, Shah, Neil P, Smith, B Douglas, Snyder, David S, Wetzler, Meir, Gregory, Kristina, and Sundar, Hema

Subjects
Pediatric, Cancer, Hematology, Rare Diseases, Orphan Drug, Pediatric Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antineoplastic Agents, Fusion Proteins, bcr-abl, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Prognosis, Protein Kinase Inhibitors, Ntational comprehensive cancer network, Oncology & Carcinogenesis
Abstract

The 2014 NCCN Clinical Practice Guidelines in Oncology for Chronic Myelogenous Leukemia recommend quantitative reverse-transcription polymerase chain reaction (QPCR) standardized to International Scale (IS) as the preferred method for monitoring molecular response to tyrosine kinase inhibitor (TKI) therapy. A BCR-ABL1 transcript level of 10% or less (IS) is now included as the response milestone at 3 and 6 months. Change of therapy to an alternate TKI is recommended for patients with BCR-ABL1 transcript levels greater than 10% (IS) at 3 months after primary treatment with imatinib. Continuing the same dose of TKI or switching to an alternate TKI are options for patients with BCR-ABL1 transcript levels greater than 10% (IS) at 3 months after primary treatment with dasatinib or nilotinib. The guidelines recommend 6-month evaluation with QPCR (IS) for patients with BCR-ABL1 transcript levels greater than 10% at 3 months. Monitoring with QPCR (IS) every 3 months is recommended for all patients, including those who meet response milestones at 3, 6, 12, and 18 months (BCR-ABL1 transcript level ≤10% [IS] at 3 and 6 months, complete cytogenetic response at 12 and 18 months).

Published
2013

34. PD-1 blockade for relapsed lymphoma post–allogeneic hematopoietic cell transplant: high response rate but frequent GVHD

Author

Haverkos, Bradley M., Abbott, Diana, Hamadani, Mehdi, Armand, Philippe, Flowers, Mary E., Merryman, Reid, Kamdar, Manali, Kanate, Abraham Sebastian, Saad, Ayman, Mehta, Amitkumar, Ganguly, Siddhartha, Fenske, Timothy S., Hari, Parameswaran, Lowsky, Robert, Andritsos, Leslie, Jagasia, Madan, Bashey, Asad, Brown, Stacey, Bachanova, Veronika, Stephens, Deborah, Mineishi, Shin, Nakamura, Ryotaro, Chen, Yi-Bin, Blazar, Bruce R., Gutman, Jonathan, and Devine, Steven M.

Published
2017
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35. Allogeneic Hematopoietic Cell Transplantation for Adult T Cell Acute Lymphoblastic Leukemia

Author

Hamilton, Betty Ky, Rybicki, Lisa, Abounader, Donna, Adekola, Kehinde, Advani, Anjali, Aldoss, Ibrahim, Bachanova, Veronika, Bashey, Asad, Brown, Stacey, DeLima, Marcos, Devine, Steven, Flowers, Christopher R., Ganguly, Siddharth, Jagasia, Madan, Kennedy, Vanessa E., Kim, Dennis Dong Hwan, McGuirk, Joseph, Pullarkat, Vinod, Romee, Rizwan, Sandhu, Karamjeet, Smith, Melody, Ueda, Masumi, Viswabandya, Auro, Vu, Khoan, Wall, Sarah, Zeichner, Simon B., Perales, Miguel-Angel, and Majhail, Navneet S.

Published
2017
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36. Outcomes after Umbilical Cord Blood Transplantation for Myelodysplastic Syndromes

Author

Gerds, Aaron T., Woo Ahn, Kwang, Hu, Zhen-Huan, Abdel-Azim, Hisham, Akpek, Gorgun, Aljurf, Mahmoud, Ballen, Karen K., Beitinjaneh, Amer, Bacher, Ulrike, Cahn, Jean-Yves, Chhabra, Saurabh, Cutler, Corey, Daly, Andrew, DeFilipp, Zachariah, Gale, Robert Peter, Gergis, Usama, Grunwald, Michael R., Hale, Gregory A., Hamilton, Betty Ky, Jagasia, Madan, Kamble, Rammurti T., Kindwall-Keller, Tamila, Nishihori, Taiga, Olsson, Richard F., Ramanathan, Muthalagu, Saad, Ayman A., Solh, Melhem, Ustun, Celalettin, Valcárcel, David, Warlick, Erica, Wirk, Baldeep M., Kalaycio, Matt, Alyea, Edwin, Popat, Uday, Sobecks, Ronald, and Saber, Wael

Published
2017
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38. The Biology of Chronic Graft-versus-Host Disease: A Task Force Report from the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease

Author

Cooke, Kenneth R., Luznik, Leo, Sarantopoulos, Stefanie, Hakim, Frances T., Jagasia, Madan, Fowler, Daniel H., van den Brink, Marcel R.M., Hansen, John A., Parkman, Robertson, Miklos, David B., Martin, Paul J., Paczesny, Sophie, Vogelsang, Georgia, Pavletic, Steven, Ritz, Jerome, Schultz, Kirk R., and Blazar, Bruce R.

Published
2017
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40. List of Contributors

Author

Ahmad, Mufti Naeem, primary, Ahmed, Sairah, additional, Arslan, Shukaib, additional, Awan, Farrukh T., additional, Bashir, Qaiser, additional, Blaise, Didier, additional, Bodge, Megan, additional, Bramanti, Stefania, additional, Castagna, Luca, additional, Costa, Luciano J., additional, Cumpston, Aaron, additional, D’Souza, Anita, additional, de Lima, Marcos, additional, Devillier, Raynier, additional, Devlin, Rebecca, additional, Dignan, Fiona L., additional, Furst, Sabine, additional, Gopalakrishnan, Ragisha, additional, Gulbis, Alison, additional, Gupta, Vikas, additional, Haider, Ali, additional, Hari, Parameswaran, additional, Hosing, Chitra, additional, Hussain, Mohammed Junaid, additional, Innis-Shelton, Racquel, additional, Jagasia, Madan, additional, Kanate, Abraham S., additional, Kebriaei, Partow, additional, Khan, Maliha, additional, Khan, Shakila P., additional, Kharfan-Dabaja, Mohamed A., additional, Kim, Sola, additional, Kohorst, Mira A., additional, Krishnan, Amrita, additional, Mehta, Rohtesh S., additional, Mir, Muhammad Ayaz, additional, Narra, Ravi Kishore, additional, Nguyen, Nhu-Nhu, additional, Nieto, Yago, additional, Nikolaenko, Liana, additional, Olson, Amanda, additional, Pillinger, Kelly E., additional, Pinnix, Chelsea C., additional, Poon, L.M., additional, Ross, Kelly G., additional, Saif, Muhammad A., additional, Shah, Nirav N., additional, Shahid, Zainab, additional, Shaw, Bronwen E., additional, Shpall, Elizabeth J., additional, Siddiqi, Rabbia, additional, Tamari, Roni, additional, Tomlinson, Benjamin, additional, Usmani, Saad Zafar, additional, Veltri, Lauren, additional, Weisdorf, Daniel, additional, Yakoub-Agha, Ibrahim, additional, and Yan, Lily, additional

Published
2019
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43. Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials

Author

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

Published
2023
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44. Supplemental Table 1 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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45. Supplemental Figure 1 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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46. supplemental figure legend from A Randomized Phase II Crossover Study of Imatinib or Rituximab for Cutaneous Sclerosis after Hematopoietic Cell Transplantation

Author

Arai, Sally, primary, Pidala, Joseph, primary, Pusic, Iskra, primary, Chai, Xiaoyu, primary, Jaglowski, Samantha, primary, Khera, Nandita, primary, Palmer, Jeanne, primary, Chen, George L., primary, Jagasia, Madan H., primary, Mayer, Sebastian A., primary, Wood, William A., primary, Green, Michael, primary, Hyun, Teresa S., primary, Inamoto, Yoshihiro, primary, Storer, Barry E., primary, Miklos, David B., primary, Shulman, Howard M., primary, Martin, Paul J., primary, Sarantopoulos, Stefanie, primary, Lee, Stephanie J., primary, and Flowers, Mary E.D., primary

Published
2023
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47. Supplemental Table 2 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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48. Supplemental Table 3 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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49. Supplemental Table 4 from Impact of Chronic Graft-versus-Host Disease on Late Relapse and Survival on 7,489 Patients after Myeloablative Allogeneic Hematopoietic Cell Transplantation for Leukemia

Author

Boyiadzis, Michael, primary, Arora, Mukta, primary, Klein, John P., primary, Hassebroek, Anna, primary, Hemmer, Michael, primary, Urbano-Ispizua, Alvaro, primary, Antin, Joseph H., primary, Bolwell, Brian J., primary, Cahn, Jean-Yves Y., primary, Cairo, Mitchell S., primary, Cutler, Corey S., primary, Flowers, Mary E., primary, Gale, Robert P., primary, Herzig, Roger, primary, Isola, Luis M., primary, Jacobsohn, David A., primary, Jagasia, Madan H., primary, Klumpp, Thomas R., primary, Lee, Stephanie J., primary, Petersdorf, Effie W., primary, Santarone, Stella, primary, Spellman, Stephen R., primary, Schouten, Harry C., primary, Verdonck, Leo F., primary, Wingard, John R., primary, Weisdorf, Daniel J., primary, Horowitz, Mary M., primary, and Pavletic, Steven Z., primary

Published
2023
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50. Supplementary Figure 2 from Dysregulated Human Myeloid Nuclear Differentiation Antigen Expression in Myelodysplastic Syndromes: Evidence for a Role in Apoptosis

Author

Briggs, Robert C., primary, Shults, Keith E., primary, Flye, Leanne A., primary, McClintock-Treep, Sara A., primary, Jagasia, Madan H., primary, Goodman, Stacey A., primary, Boulos, Fouad I., primary, Jacobberger, James W., primary, Stelzer, Greg T., primary, and Head, David R., primary

Published
2023
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