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151. A Double-Blind, Placebo-Controlled, Phase 3 Registration Trial to Evaluate the Efficacy of Uproleselan (GMI-1271) with Standard Salvage Chemotherapy in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia

Author

DeAngelo, Daniel J., primary, Erba, Harry P., additional, Jonas, Brian A, additional, O'Dwyer, Michael E, additional, Marlton, Paula, additional, Huls, Gerwin, additional, Liesveld, Jane L., additional, Cooper, Brenda, additional, Bhatnagar, Bhavana, additional, Uy, Geoffrey L., additional, Cull, Gavin, additional, Armstrong, Michael B., additional, Fogler, William E., additional, Chen, Mary M, additional, Magnani, John L., additional, Thackray, Helen M, additional, Feldman, Eric J., additional, Advani, Anjali S., additional, and Becker, Pamela S., additional

Published
2019
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153. Genetic Characteristics and Outcomes By Mutation Status in a Phase 3 Study of CPX-351 Versus 7+3 in Older Adults with Newly Diagnosed, High-Risk/Secondary Acute Myeloid Leukemia (AML)

Author

Lindsley, R. Coleman, primary, Gibson, Christopher J., primary, Murdock, H. Moses, primary, Stone, Richard M., primary, Cortes, Jorge E., primary, Uy, Geoffrey L., primary, Lin, Tara L., primary, Ritchie, Ellen K., primary, Prebet, Thomas, primary, Ryan, Robert J., primary, Faderl, Stefan, primary, and Lancet, Jeffrey E., primary

Published
2019
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155. Flotetuzumab, an Investigational CD123 x CD3 Bispecific Dart® Protein, in Salvage Therapy for Primary Refractory and Early Relapsed Acute Myeloid Leukemia (AML) Patients

Author

Uy, Geoffrey L., primary, Aldoss, Ibrahim, primary, Foster, Matthew C, primary, Sallman, David A, primary, Sweet, Kendra L., primary, Rizzieri, David A., primary, Sayre, Peter H., primary, Advani, Anjali S., primary, Emadi, Ashkan, primary, Wieduwilt, Matthew J., primary, Vey, Norbert, primary, Ciceri, Fabio, primary, Carrabba, Matteo Giovanni, primary, Moyo, Tamara, primary, Church, Sarah E., primary, Rettig, Michael P., primary, Arellano, Martha L., primary, Godwin, John E., primary, Löwenberg, Bob, primary, Huls, Gerwin, primary, Ravandi, Farhad, primary, Muth, John, primary, Tran, Kathy, primary, Jongen-Lavrencic, Mojca, primary, Timmeny, Erin, primary, Topp, Max S., primary, Paolini, Stefania, primary, Guo, Kuo, primary, Curtis, Teia, primary, Zhao, Jian, primary, Vadakekolathu, Jayakumar, primary, Wigginton, Jon M., primary, Bonvini, Ezio, primary, Rutella, Sergio, primary, Walter, Roland B., primary, Davidson-Moncada, Jan K, primary, and DiPersio, John F., primary

Published
2019
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156. Improvement in Cytokine Release Syndrome Management for the Treatment of AML Patients with Flotetuzumab, a CD123 x CD3 Bispecific Dart® Molecule for T-Cell Redirected Therapy

Author

Bakkacha, Ouiam, primary, Uy, Geoffrey L., additional, Aldoss, Ibrahim, additional, Foster, Matthew C, additional, Sallman, David A, additional, Sweet, Kendra L., additional, Rizzieri, David A., additional, Sayre, Peter H., additional, Advani, Anjali S., additional, Emadi, Ashkan, additional, Wieduwilt, Matthew J., additional, Vey, Norbert, additional, Ciceri, Fabio, additional, Carrabba, Matteo Giovanni, additional, Moyo, Tamara, additional, Arellano, Martha L., additional, Godwin, John E., additional, Löwenberg, Bob, additional, Huls, Gerwin, additional, Ravandi, Farhad, additional, Tran, Kathy, additional, Muth, John, additional, Baughman, Jan, additional, Jongen-Lavrencic, Mojca, additional, Timmeny, Erin, additional, Topp, Max S., additional, Paolini, Stefania, additional, Guo, Kuo, additional, Curtis, Teia, additional, Zhao, Jian, additional, Wigginton, Jon, additional, Bonvini, Ezio, additional, Walter, Roland B., additional, Davidson, Jan, additional, DiPersio, John F., additional, and Jacobs, Kenneth, additional

Published
2019
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157. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia

Author

Walker, Christopher J., primary, Kohlschmidt, Jessica, additional, Eisfeld, Ann-Kathrin, additional, Mrózek, Krzysztof, additional, Liyanarachchi, Sandya, additional, Song, Chi, additional, Nicolet, Deedra, additional, Blachly, James S., additional, Bill, Marius, additional, Papaioannou, Dimitrios, additional, Oakes, Christopher C., additional, Giacopelli, Brian, additional, Genutis, Luke K., additional, Maharry, Sophia E., additional, Orwick, Shelley, additional, Archer, Kellie J., additional, Powell, Bayard L., additional, Kolitz, Jonathan E., additional, Uy, Geoffrey L., additional, Wang, Eunice S., additional, Carroll, Andrew J., additional, Stone, Richard M., additional, Byrd, John C., additional, de la Chapelle, Albert, additional, and Bloomfield, Clara D., additional

Published
2019
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160. 386 - A Single-Arm, Open-Label, Pilot Study of the JAK1 Selective Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome in T-Cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Author

Abboud, Ramzi, Gao, Feng, Rettig, Michael P., Abboud, Jeremy, Gehrs, Leah, Wallace, Nicholas, Abboud, Camille, Westervelt, Peter, Uy, Geoffrey L., Cashen, Amanda, Christopher, Matthew, Ghobadi, Armin, Jacoby, Meagan, Pusic, Iskra, Stockerl-Goldstein, Keith, DiPersio, John F., and Schroeder, Mark A.

Published
2022
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162. BL‐8040 CXCR4 antagonist is safe and demonstrates antileukemic activity in combination with cytarabine for the treatment of relapsed/refractory acute myelogenous leukemia: An open‐label safety and efficacy phase 2a study.

Author

Borthakur, Gautam, Ofran, Yishai, Tallman, Martin S., Foran, James, Uy, Geoffrey L., DiPersio, John F., Showel, Margaret M., Shimoni, Avichai, Nagler, Arnon, Rowe, Jacob M., Altman, Jessica K., Abraham, Michal, Peled, Amnon, Shaw, Stephen, Bohana‐Kashtan, Osnat, Sorani, Ella, Pereg, Yaron, Foley‐Comer, Adam, Oberkovitz, Galia, and Lustig, Tzipi M.

Subjects
ACUTE myeloid leukemia, DRUG efficacy, CXCR4 receptors, CYTARABINE, BONE marrow, MAXILLARY expansion, EARLY ambulation (Rehabilitation)
Abstract

Background: CXCR4 mediates the retention and survival of acute myelogenous leukemia blasts in bone marrow and contributes to their resistance to chemotherapy. The authors evaluated a combination of the high‐affinity CXCR4 antagonist BL‐8040 with high‐dose cytarabine (HiDAC) chemotherapy in a phase 2a study of patients with relapsed and refractory AML. Methods: Forty‐two patients received treatment with BL‐8040 monotherapy for 2 days followed by a combination of BL‐8040 with HiDAC for 5 days. Six escalating BL‐8040 dose levels were investigated (0.5, 0.75, 1.0, 1.25, 1.5, and 2.0 mg/kg), and 1.5 mg/kg was selected as the dose for the expansion phase (n = 23). Results: BL‐8040 in combination with HiDAC was safe and well tolerated at all dose levels. Clinical response was observed with BL‐8040 doses ≥1.0 mg/kg. The composite response rate (complete remissions plus complete remissions with incomplete hematologic recovery of platelets or neutrophils) was 29% (12 of 42) in all patients and 39% (9 of 23) in the 1.5‐mg/kg phase. The median overall survival was 8.4 months for all patients, 10.8 months in the 1.5‐mg/kg phase, and 21.8 months for responding patients in the 1.5‐mg/kg cohort. Two days of BL‐8040 monotherapy triggered the mobilization of blasts into peripheral blood, with significantly higher mean fold‐changes in responders versus nonresponders. This was accompanied by a decrease in bone marrow blasts. Conclusions: The current results demonstrate the efficacy of CXCR4 targeting with BL‐8040 and support continued clinical development in acute myelogenous leukemia. BL‐8040 is a high‐affinity CXCR4 inhibitor. Combined with cytarabine, BL‐8040 treatment results in improved composite complete response rates and median overall survival in hard‐to‐treat patients with relapsed/refractory acute myelogenous leukemia. [ABSTRACT FROM AUTHOR]

Published
2021
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164. Ivosidenib (IVO; AG-120) in IDH1-Mutant Newly-Diagnosed Acute Myeloid Leukemia (ND AML): Updated Results from a Phase 1 Study

Author

DiNardo, Courtney D., primary, Roboz, Gail J., additional, Stein, Eytan M., additional, de Botton, Stéphane, additional, Mims, Alice S., additional, Prince, Gabrielle T., additional, Altman, Jessica K., additional, Arellano, Martha L., additional, Donnellan, Will, additional, Erba, Harry P., additional, Mannis, Gabriel N., additional, Pollyea, Daniel A., additional, Stein, Anthony S., additional, Uy, Geoffrey L., additional, Watts, Justin M., additional, Fathi, Amir T., additional, Kantarjian, Hagop M., additional, Tallman, Martin S., additional, Choe, Sung, additional, Dai, David, additional, Fan, Bin, additional, Wang, Hongfang, additional, Zhang, Vickie, additional, Yen, Katharine E., additional, Kapsalis, Stephanie M., additional, Hickman, Denice, additional, Liu, Hua, additional, Agresta, Samuel V., additional, Wu, Bin, additional, Attar, Eyal C., additional, and Stone, Richard M., additional

Published
2019
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166. Guidelines Insights: Acute Lymphoblastic Leukemia, Version 1.2019

Author

Brown, Patrick A., primary, Wieduwilt, Matthew, additional, Logan, Aaron, additional, DeAngelo, Daniel J., additional, Wang, Eunice S., additional, Fathi, Amir, additional, Cassaday, Ryan D., additional, Litzow, Mark, additional, Advani, Anjali, additional, Aoun, Patricia, additional, Bhatnagar, Bhavana, additional, Boyer, Michael W., additional, Bryan, Teresa, additional, Burke, Patrick W., additional, Coccia, Peter F., additional, Coutre, Steven E., additional, Jain, Nitin, additional, Kirby, Suzanne, additional, Liu, Arthur, additional, Massaro, Stephanie, additional, Mattison, Ryan J., additional, Oluwole, Olalekan, additional, Papadantonakis, Nikolaos, additional, Park, Jae, additional, Rubnitz, Jeffrey E., additional, Uy, Geoffrey L., additional, Gregory, Kristina M., additional, Ogba, Ndiya, additional, and Shah, Bijal, additional

Published
2019
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168. Phase 1 Cohort Expansion of Flotetuzumab, a CD123×CD3 Bispecific Dart® Protein in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML)

Author

Uy, Geoffrey L., primary, Rettig, Michael P., additional, Vey, Norbert, additional, Godwin, John, additional, Foster, Matthew C, additional, Rizzieri, David A., additional, Arellano, Martha L., additional, Topp, Max S., additional, Huls, Gerwin, additional, Jongen-Lavrencic, Mojca, additional, Martinelli, Giovanni, additional, Paolini, Stefania, additional, Ciceri, Fabio, additional, Carrabba, Matteo Giovanni, additional, Sweet, Kendra L., additional, Ravandi, Farhad, additional, Church, Sarah E., additional, Vadakekolathu, Jayakumar, additional, Rutella, Sergio, additional, Sun, Jichao, additional, Yang, Kang, additional, Baughman, Jan, additional, Curtis, Teia, additional, Timmeny, Erin, additional, Cali, Kerri, additional, Tran, Kathy, additional, Muth, John, additional, La Motte-Mohs, Ross, additional, Poirot, Camille, additional, Pallis, Athanasios, additional, Cesano, Alessandra, additional, Bonvini, Ezio, additional, Wigginton, Jon, additional, Lowenberg, Bob, additional, Davidson-Moncada, Jan K, additional, and DiPersio, John F., additional

Published
2018
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169. Management of Cytokine Release Syndrome in AML Patients Treated with Flotetuzumab, a CD123 x CD3 Bispecific Dart® Molecule for T-Cell Redirected Therapy

Author

Jacobs, Kenneth, primary, Viero, Cedric, additional, Godwin, John, additional, Baughman, Jan, additional, Sun, Jichao, additional, Ying, Kang, additional, Muth, John, additional, Hong, Shengyan, additional, Vey, Norbert, additional, Sweet, Kendra L., additional, Uy, Geoffrey L., additional, Ravandi, Farhad, additional, Foster, Matthew C, additional, Rizzieri, David A., additional, Arellano, Martha L., additional, Rettig, Michael P., additional, Topp, Max S., additional, Huls, Gerwin, additional, Lelièvre, Helene, additional, Paolini, Stefania, additional, Ciceri, Fabio, additional, Carrabba, Matteo Giovanni, additional, Lowenberg, Bob, additional, DiPersio, John F., additional, Wigginton, Jon, additional, and Davidson-Moncada, Jan K, additional

Published
2018
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171. Prognostic and Biologic Significance of Transfer RNA-Derived Small RNAs (tsRNAs) Expression in Younger Adult Patients (Pts) with Cytogenetically Normal Acute Myeloid Leukemia (CN-AML)

Author

Bill, Marius, primary, Veneziano, Dario, additional, Kohlschmidt, Jessica, additional, Mrózek, Krzysztof, additional, Nigita, Giovanni, additional, Krantz, Maria G., additional, Nicolet, Deedra, additional, Papaioannou, Dimitrios, additional, Walker, Allison, additional, Brannan, Zachary, additional, Powell, Bayard L., additional, Stone, Richard M., additional, Uy, Geoffrey L., additional, Kolitz, Jonathan E., additional, Wang, Eunice S., additional, Dorrance, Adrienne M., additional, Croce, Carlo M., additional, Garzon, Ramiro, additional, and Bloomfield, Clara D., additional

Published
2018
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172. Prognostic and Biologic Significance of Long Non-Coding RNA (lncRNA) Profiling in Cytogenetically Abnormal Acute Myeloid Leukemia (CA-AML)

Author

Papaioannou, Dimitrios, primary, Nicolet, Deedra, additional, Rong-Mullins, Xiaoqing, additional, Mrózek, Krzysztof, additional, Kohlschmidt, Jessica, additional, Carroll, Andrew J., additional, Archer, Kellie J, additional, Kolitz, Jonathan E., additional, Powell, Bayard L., additional, Stone, Richard M., additional, Uy, Geoffrey L., additional, Wang, Eunice S., additional, Stock, Wendy, additional, Garzon, Ramiro, additional, and Bloomfield, Clara D., additional

Published
2018
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173. The Impact of Hematopoietic Cell Transplantation on Survival: An Exploratory Analysis of a Phase 3 Study of CPX-351 Versus 7+3 in Older Patients with Newly Diagnosed, High-Risk/Secondary AML

Author

Lin, Tara L, primary, Cortes, Jorge E., additional, Newell, Laura F., additional, Ritchie, Ellen K., additional, Stuart, Robert K., additional, Strickland, Stephen A., additional, Hogge, Donna, additional, Solomon, Scott R, additional, Stone, Richard M., additional, Bixby, Dale L., additional, Kolitz, Jonathan E., additional, Schiller, Gary J., additional, Wieduwilt, Matthew J., additional, Ryan, Daniel H., additional, Ryan, Robert, additional, Chiarella, Michael, additional, Louie, Arthur C., additional, and Uy, Geoffrey L., additional

Published
2018
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174. A Phase II Study of Dasatinib and Dexamethasone As Primary Therapy Followed By Transplantation for Adults with Newly Diagnosed Ph/BCR-ABL1-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Final Results of Alliance/CALGB Study 10701

Author

Wieduwilt, Matthew J., primary, Yin, Jun, additional, Wetzler, Meir, additional, Uy, Geoffrey L., additional, Powell, Bayard L., additional, Kolitz, Jonathan E., additional, Liedtke, Michaela, additional, Stock, Wendy, additional, Beumer, Jan H, additional, Mattison, Ryan J., additional, Storrick, Elizabeth, additional, Devine, Steven, additional, Smith, Scott E., additional, Stone, Richard M., additional, and Larson, Richard A., additional

Published
2018
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175. Improving Risk Assessment of AML with a Precision Genomic Strategy to Assess Mutation Clearance

Author

Jacoby, Meagan, primary, Spencer, David H, additional, Hughes, Emma, additional, Fulton, Robert S, additional, O'Laughlin, Michelle, additional, Fronick, Catrina, additional, Loken, Michael R., additional, Baty, Jack D, additional, Schroeder, Mark A., additional, Ghobadi, Armin, additional, Uy, Geoffrey L., additional, Vij, Ravi, additional, Kahl, Brad S, additional, Cashen, Amanda F, additional, Walter, Matthew J., additional, Wartman, Lukas D, additional, Welch, John S., additional, DiPersio, John F., additional, Westervelt, Peter, additional, and Ley, Timothy J, additional

Published
2018
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176. Event-Free Survival As a Surrogate Endpoint for Overall Survival in Previously Untreated Acute Myeloid Leukemia: An Individual Patient-Level Analysis of Multiple Randomized Trials (Alliance A151614)

Author

Yin, Jun, primary, Uy, Geoffrey L., additional, Laplant, Betsy, additional, Storrick, Elizabeth, additional, Marcucci, Guido, additional, Fernandez, Hugo F., additional, Sun, Zhuoxin, additional, Litzow, Mark R., additional, Othus, Megan, additional, Appelbaum, Frederick R., additional, Larson, Richard A., additional, Stone, Richard M., additional, and Mandrekar, Sumithra J, additional

Published
2018
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177. Allogeneic Hematopoietic Cell Transplantation (HCT) Vs. Non-HCT Consolidation Therapies in Acute Myeloid Leukemia (AML) Patients 60-75 Years of Age in First Complete Remission (CR1): An Alliance (A151509), SWOG, ECOG-ACRIN and CIBMTR Study

Author

Ustun, Celalettin, primary, Le-Rademacher, Jennifer, additional, Wang, Hai-Lin, additional, Othus, Megan, additional, Sun, Zhuoxin, additional, Major, Brittny, additional, Zhang, Mei-Jie, additional, Storrick, Elizabeth, additional, Lafky, Jacqueline M, additional, Chow, Selina, additional, Mrózek, Krzysztof, additional, Attar, Eyal C., additional, Bloomfield, Clara D., additional, Cripe, Larry D, additional, Larson, Richard A., additional, Marcucci, Guido, additional, Roboz, Gail J., additional, Uy, Geoffrey L., additional, Stone, Richard M., additional, Jatoi, Aminah, additional, Shea, Thomas C., additional, de Lima, Marcos, additional, Foran, James M., additional, Sandmaier, Brenda M., additional, Litzow, Mark R., additional, Erba, Harry P., additional, Hurria, Arti, additional, Weisdorf, Daniel J., additional, and Artz, Andrew S, additional

Published
2018
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178. Efficacy and Safety of CPX-351 Versus 7+3 in a Subgroup of Older Patients with Newly Diagnosed Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Enrolled in a Phase 3 Study

Author

Ryan, Daniel H., primary, Uy, Geoffrey L., additional, Cortes, Jorge E., additional, Newell, Laura F., additional, Ritchie, Ellen K., additional, Stuart, Robert K., additional, Strickland, Stephen A., additional, Hogge, Donna, additional, Solomon, Scott R, additional, Stone, Richard M., additional, Bixby, Dale L., additional, Kolitz, Jonathan E., additional, Schiller, Gary J., additional, Wieduwilt, Matthew J., additional, Ryan, Robert, additional, Chiarella, Michael, additional, Louie, Arthur C., additional, and Lancet, Jeffrey E., additional

Published
2018
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179. Ivosidenib (AG-120) Induced Durable Remissions and Transfusion Independence in Patients with IDH1-Mutant Untreated AML: Results from a Phase 1 Dose Escalation and Expansion Study

Author

Roboz, Gail J., primary, DiNardo, Courtney D., additional, Stein, Eytan M., additional, de Botton, Stephane, additional, Mims, Alice S., additional, Prince, Gabrielle T., additional, Altman, Jessica K., additional, Arellano, Martha L., additional, Donnellan, William B., additional, Erba, Harry P., additional, Mannis, Gabriel N., additional, Pollyea, Daniel A, additional, Stein, Anthony S., additional, Uy, Geoffrey L., additional, Watts, Justin M., additional, Fathi, Amir T., additional, Kantarjian, Hagop M., additional, Tallman, Martin S., additional, Choe, Sung, additional, Dai, David, additional, Fan, Bin, additional, Wang, Hongfang, additional, Zhang, Vickie, additional, Yen, Katharine E., additional, Kapsalis, Stephanie M., additional, Hickman, Denice, additional, Liu, Hua, additional, Agresta, Samuel V., additional, Wu, Bin, additional, Attar, Eyal C., additional, and Stone, Richard M., additional

Published
2018
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180. Phase II Study Evaluating the Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem and Progenitor Cells for Allogeneic Hematopoietic Cell Transplantation and Phenotypic Characterization of the Leukapheresis Product

Author

Rettig, Michael P., primary, Uy, Geoffrey L., additional, Bashey, Asad, additional, Devine, Steven, additional, Jaglowski, Samantha, additional, Vainstein, Abi, additional, Sorani, Ella, additional, Chen, Hemda, additional, Bohana-Kashtan, Osnat, additional, Shaw, Stephen, additional, Westervelt, Peter, additional, and DiPersio, John F., additional

Published
2018
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181. Mutational landscape and response are conserved in peripheral blood of AML and MDS patients during decitabine therapy

Author

Duncavage, Eric J., Uy, Geoffrey L., Petti, Allegra A., Miller, Christopher A., Lee, Yi-Shan, Tandon, Bevan, Gao, Feng, Fronick, Catrina C., O'Laughlin, Michelle, Fulton, Robert S., Wilson, Richard K., Jacoby, Meagan A., Cashen, Amanda F., Wartman, Lukas D., Walter, Matthew J., Westervelt, Peter, Link, Daniel C., DiPersio, John F., Ley, Timothy J., and Welch, John S.

Published
2017
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182. Junior investigators: Get engaged in the Alliance for Clinical Trials in Oncology

Author

Uy, Geoffrey L., Katz, Matthew H. G., and Boughey, Judy C.

Subjects
Clinical Trials as Topic, Biomedical Research, Surgical Oncology, Humans, Article, United States
Abstract

The success of the Alliance and the cooperative groups in the National Cancer Institute's National Clinical Trials Network is dependent on the cooperative group's ability to help recruit and train the next generation of clinical researchers.

Published
2017

183. A phase 1 study of the MDM2 antagonist RO6839921, a pegylated prodrug of idasanutlin, in patients with advanced solid tumors.

Author

Abdul Razak, Albiruni R., Miller, Wilson H., Uy, Geoffrey L., Blotner, Steven, Young, Anne-Marie, Higgins, Brian, Chen, Lin-Chi, and Gore, Lia

Subjects
CLINICAL trials, CYTOKINES, DOSE-effect relationship in pharmacology, DRUG toxicity, FATIGUE (Physiology), IMIDAZOLES, INTRAVENOUS therapy, NAUSEA, NEUTROPENIA, PRODRUGS, PROTEINS, THROMBOCYTOPENIA, TUMORS, VOMITING, TREATMENT effectiveness, DESCRIPTIVE statistics, CHEMICAL inhibitors, PHARMACODYNAMICS
Abstract

Summary: Purpose MDM2 is a negative regulator of the tumor suppressor p53. RO6839921 is an inactive pegylated prodrug of idasanutlin, an MDM2 antagonist, developed for intravenous administration. On cleavage by plasma esterases, the active principle (AP = idasanutlin) is released. This phase 1 study investigated the safety, pharmacokinetics, and pharmacodynamics of RO6839921 in patients with advanced solid tumors (NCT02098967). Methods Patients were evaluated on a 5-day dosing schedule every 28 days. Dose escalation used the Bayesian new continual reassessment model. Accelerated dose titration was permitted until grade ≥2 drug-related AEs were observed. The target DLT rate to define the MTD was 16–25%. p53 activation was assessed by measuring macrophage inhibitory cytokine-1 (MIC-1). Results Forty-one patients received 14–120 mg AP; 39 were DLT evaluable. The MTD was 110-mg AP (8% DLT rate), whereas 120-mg AP had a 44% DLT rate. DLTs were neutropenia, thrombocytopenia, and stridor. The most common treatment-related AEs (≥30%) were nausea, fatigue, vomiting, and thrombocytopenia. Pharmacokinetic analyses indicated rapid conversion of prodrug to AP and an approximately linear and dose-proportional dose-exposure relationship, with a 2-fold increase in exposure between Days 1 and 5 of AP. MIC-1 increases were exposure dependent. Stable disease was observed in 14 patients (34%). Conclusions RO6839921 showed reduced pharmacokinetic exposure variability and a safety profile comparable with that of oral idasanutlin. Although this study indicated that RO6839921 could be administered to patients, the results did not provide sufficient differentiation or improvement in the biologic or safety profile compared with oral idasanutlin to support continued development. [ABSTRACT FROM AUTHOR]

Published
2020
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186. Mutation Clearance after Transplantation for Myelodysplastic Syndrome

Author

Duncavage, Eric J., primary, Jacoby, Meagan A., additional, Chang, Gue Su, additional, Miller, Christopher A., additional, Edwin, Natasha, additional, Shao, Jin, additional, Elliott, Kevin, additional, Robinson, Joshua, additional, Abel, Haley, additional, Fulton, Robert S., additional, Fronick, Catrina C., additional, O’Laughlin, Michelle, additional, Heath, Sharon E., additional, Brendel, Kimberly, additional, Saba, Raya, additional, Wartman, Lukas D., additional, Christopher, Matthew J., additional, Pusic, Iskra, additional, Welch, John S., additional, Uy, Geoffrey L., additional, Link, Daniel C., additional, DiPersio, John F., additional, Westervelt, Peter, additional, Ley, Timothy J., additional, Trinkaus, Kathryn, additional, Graubert, Timothy A., additional, and Walter, Matthew J., additional

Published
2018
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187. CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia

Author

Lancet, Jeffrey E., primary, Uy, Geoffrey L., additional, Cortes, Jorge E., additional, Newell, Laura F., additional, Lin, Tara L., additional, Ritchie, Ellen K., additional, Stuart, Robert K., additional, Strickland, Stephen A., additional, Hogge, Donna, additional, Solomon, Scott R., additional, Stone, Richard M., additional, Bixby, Dale L., additional, Kolitz, Jonathan E., additional, Schiller, Gary J., additional, Wieduwilt, Matthew J., additional, Ryan, Daniel H., additional, Hoering, Antje, additional, Banerjee, Kamalika, additional, Chiarella, Michael, additional, Louie, Arthur C., additional, and Medeiros, Bruno C., additional

Published
2018
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188. Outcomes in Older Patients with Newly Diagnosed, High-risk/Secondary Acute Myeloid Leukemia (sAML) Who Received Consolidation in a Phase 3 Study of CPX-351 versus Conventional 7+3/5+2 Cytarabine and Daunorubicin

Author

Kolitz, Jonathan, primary, Strickland, Stephen A., additional, Cortes, Jorge E., additional, Hogge, Donna, additional, Lancet, Jeffrey E., additional, Goldberg, Stuart, additional, Ryan, Robert J., additional, Chiarella, Michael, additional, Louie, Arthur C., additional, and Uy, Geoffrey L., additional

Published
2018
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189. A Phase 3 Study of CPX-351 versus Conventional 7+3 Cytarabine and Daunorubicin: Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-t)

Author

Lin, Tara L., primary, Wieduwilt, Matthew J., additional, Newell, Laura F., additional, Schiller, Gary J., additional, Rubenstein, S. Eric, additional, Stock, Wendy, additional, Warlick, Erica, additional, Bixby, Dale L., additional, Podoltsev, Nikolai, additional, An, Qi, additional, Faderl, Stefan, additional, Louie, Arthur C., additional, and Uy, Geoffrey L., additional

Published
2018
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190. Ivosidenib (AG-120) in Mutant IDH1 Relapsed/Refractory Acute Myeloid Leukemia: Results of a Phase 1 Study

Author

DiNardo, Courtney D., primary, Stein, Eytan M., additional, de Botton, Stéphane, additional, Roboz, Gail J., additional, Altman, Jessica K., additional, Mims, Alice S., additional, Swords, Ronan, additional, Collins, Robert H., additional, Mannis, Gabriel N., additional, Pollyea, Daniel A., additional, Donnellan, Will, additional, Fathi, Amir T., additional, Pigneux, Arnaud, additional, Erba, Harry P., additional, Prince, Gabrielle T., additional, Stein, Anthony S., additional, Uy, Geoffrey L., additional, Foran, James M., additional, Traer, Elie, additional, Stuart, Robert K., additional, Arellano, Martha L., additional, Slack, James L., additional, Sekeres, Mikkael A., additional, Willekens, Christophe, additional, Choe, Sung, additional, Wang, Hongfang, additional, Zhang, Vickie, additional, Yen, Katharine E., additional, Kapsalis, Stephanie M., additional, Yang, Hua, additional, Dai, David, additional, Fan, Bin, additional, Goldwasser, Meredith, additional, Liu, Hua, additional, Agresta, Sam, additional, Wu, Bin, additional, Attar, Eyal C., additional, Tallman, Martin S., additional, Stone, Richard M., additional, and Kantarjian, Hagop M., additional

Published
2018
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191. Durable Remissions with Ivosidenib inIDH1-Mutated Relapsed or Refractory AML

Author

DiNardo, Courtney D., primary, Stein, Eytan M., additional, de Botton, Stéphane, additional, Roboz, Gail J., additional, Altman, Jessica K., additional, Mims, Alice S., additional, Swords, Ronan, additional, Collins, Robert H., additional, Mannis, Gabriel N., additional, Pollyea, Daniel A., additional, Donnellan, Will, additional, Fathi, Amir T., additional, Pigneux, Arnaud, additional, Erba, Harry P., additional, Prince, Gabrielle T., additional, Stein, Anthony S., additional, Uy, Geoffrey L., additional, Foran, James M., additional, Traer, Elie, additional, Stuart, Robert K., additional, Arellano, Martha L., additional, Slack, James L., additional, Sekeres, Mikkael A., additional, Willekens, Christophe, additional, Choe, Sung, additional, Wang, Hongfang, additional, Zhang, Vickie, additional, Yen, Katharine E., additional, Kapsalis, Stephanie M., additional, Yang, Hua, additional, Dai, David, additional, Fan, Bin, additional, Goldwasser, Meredith, additional, Liu, Hua, additional, Agresta, Sam, additional, Wu, Bin, additional, Attar, Eyal C., additional, Tallman, Martin S., additional, Stone, Richard M., additional, and Kantarjian, Hagop M., additional

Published
2018
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192. A case of acute myeloid leukemia with promyelocytic features characterized by expression of a novel RARG-CPSF6 fusion

Author

Miller, Christopher A., primary, Tricarico, Christopher, additional, Skidmore, Zachary L., additional, Uy, Geoffrey L., additional, Lee, Yi-Shan, additional, Hassan, Anjum, additional, O’Laughlin, Michelle D., additional, Schmidt, Heather, additional, Tian, Ling, additional, Duncavage, Eric J., additional, Griffith, Malachi, additional, Griffith, Obi L., additional, Welch, John S., additional, and Wartman, Lukas D., additional

Published
2018
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193. Phase 1 trial of pegzilarginase in patients (pts) with relapsed/refractory (R/R) AML or MDS refractory to hypomethylating agents (HMAs).

Author

Uy, Geoffrey L., primary, Savona, Michael R., additional, Tomlinson, Benjamin K., additional, Carraway, Hetty, additional, Bixby, Dale L., additional, Assouline, Sarit E., additional, Brandwein, Joseph M., additional, Levy, Moshe Yair, additional, Collins, Robert, additional, Lara-Guerra, Humberto, additional, Alters, Susan, additional, Eckert, Stephen, additional, Rowlinson, Scott, additional, Wooldridge, James, additional, and Schimmer, Aaron David, additional

Published
2018
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195. Outcomes by number of induction cycles with CPX-351 vs 7+3 chemotherapy in older adults with newly diagnosed, high-risk/secondary acute myeloid leukemia (sAML).

Author

Lin, Tara L., primary, Medeiros, Bruno C., additional, Uy, Geoffrey L., additional, Newell, Laura Fugal, additional, Ritchie, Ellen K., additional, Stuart, Robert K., additional, Strickland, Stephen Anthony, additional, Hogge, Donna, additional, Solomon, Scott R., additional, Stone, Richard M., additional, Bixby, Dale L., additional, Kolitz, Jonathan E., additional, Schiller, Gary J., additional, Wieduwilt, Matthew Joseph, additional, Ryan, Daniel H., additional, Ryan, Robert J, additional, Chiarella, Michael, additional, Louie, Arthur Chin, additional, Lancet, Jeffrey E., additional, and Cortes, Jorge E., additional

Published
2018
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196. Ivosidenib (IVO; AG-120) in mutant IDH1 relapsed/refractory acute myeloid leukemia (R/R AML): Results of a phase 1 study.

Author

Pollyea, Daniel Aaron, primary, Dinardo, Courtney Denton, additional, de Botton, Stéphane, additional, Stein, Eytan, additional, Roboz, Gail J., additional, Mims, Alice S., additional, Swords, Ronan T., additional, Altman, Jessica K, additional, Collins, Robert, additional, Mannis, Gabriel N., additional, Uy, Geoffrey L., additional, Donnellan, William Bruce, additional, Pigneux, Arnaud, additional, Fathi, Amir Tahmasb, additional, Liu, Hua, additional, Wu, Bin, additional, Attar, Eyal C., additional, Tallman, Martin S., additional, Stone, Richard M., additional, and Kantarjian, Hagop M., additional

Published
2018
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197. Phase I studies of AZD1208, a proviral integration Moloney virus kinase inhibitor in solid and haematological cancers

Author

Cortes, Jorge, primary, Tamura, Kenji, additional, DeAngelo, Daniel J., additional, de Bono, Johann, additional, Lorente, David, additional, Minden, Mark, additional, Uy, Geoffrey L., additional, Kantarjian, Hagop, additional, Chen, Lisa S., additional, Gandhi, Varsha, additional, Godin, Robert, additional, Keating, Karen, additional, McEachern, Kristen, additional, Vishwanathan, Karthick, additional, Pease, Janet Elizabeth, additional, and Dean, Emma, additional

Published
2018
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198. Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-T) Enrolled in a Phase 3 Study of CPX-351 Versus Conventional 7 + 3 Cytarabine and Daunorubicin

Author

Lin, Tara L., primary, Uy, Geoffrey L., additional, Wieduwilt, Matthew J., additional, Newell, Laura F., additional, Stuart, Robert K., additional, Medeiros, Bruno C., additional, Schiller, Gary J., additional, Rubenstein, S. Eric, additional, Stock, Wendy, additional, Warlick, Erica, additional, Foster, Matthew, additional, Bixby, Dale L., additional, Podoltsev, Nikolai, additional, An, Qi, additional, Faderl, Stefan, additional, Louie, Arthur C., additional, and Lancet, Jeffrey E., additional

Published
2018
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200. Acute graft-versus-host disease following lung transplantation in a patient with a novel TERT mutation

Author

Brestoff, Jonathan R, primary, Vessoni, Alexandre T, additional, Brenner, Kirsten A, additional, Uy, Geoffrey L, additional, DiPersio, John F, additional, Blinder, Morey, additional, Witt, Chad A, additional, Byers, Derek E, additional, Hachem, Ramsey R, additional, Truclock, Elbert P, additional, Early, Dayna S, additional, Anadkat, Milan J, additional, Musiek, Amy, additional, Javidan-Nejad, Cylen, additional, Balfe, Dennis M, additional, Rosman, Ilana S, additional, Liu, Chang, additional, Zhang, Lingxin, additional, Despotis, George J, additional, Ruzinova, Marianna B, additional, Sehn, Jennifer K, additional, Amarillo, Ina, additional, Heusel, Jonathan W, additional, Swat, Wojcieh, additional, Kim, Brian S, additional, Wartman, Lukas D, additional, Yusen, Roger D, additional, and Batista, Luis F Z, additional

Published
2018
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