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2. A study to assess the efficacy of enasidenib and risk-adapted addition of azacitidine in newly diagnosed IDH2-mutant AML.

Author

Cai, Sheng, Huang, Ying, Lance, Jennie, Mao, Hsiaoyin, Dunbar, Andrew, McNulty, Samantha, Druley, Todd, Li, Yan, Baer, Maria, Stock, Wendy, Kovacsovics, Tibor, Blum, William, Olin, Rebecca, Foran, James, Litzow, Mark, Lin, Tara, Patel, Prapti, Foster, Matthew, Boyiadzis, Michael, Collins, Robert, Chervin, Jordan, Shoben, Abigail, Vergilio, Jo-Anne, Heerema, Nyla, Rosenberg, Leonard, Chen, Timothy, Yocum, Ashley, Druggan, Franchesca, Marcus, Sonja, Stefanos, Mona, Druker, Brian, Mims, Alice, Borate, Uma, Burd, Amy, Byrd, John, Levine, Ross, Stein, Eytan, and Schiller, Gary

Subjects
Humans, Azacitidine, Isocitrate Dehydrogenase, Mutation, Leukemia, Myeloid, Acute, Pathologic Complete Response, Aminopyridines, Triazines
Abstract

Enasidenib (ENA) is an inhibitor of isocitrate dehydrogenase 2 (IDH2) approved for the treatment of patients with IDH2-mutant relapsed/refractory acute myeloid leukemia (AML). In this phase 2/1b Beat AML substudy, we applied a risk-adapted approach to assess the efficacy of ENA monotherapy for patients aged ≥60 years with newly diagnosed IDH2-mutant AML in whom genomic profiling demonstrated that mutant IDH2 was in the dominant leukemic clone. Patients for whom ENA monotherapy did not induce a complete remission (CR) or CR with incomplete blood count recovery (CRi) enrolled in a phase 1b cohort with the addition of azacitidine. The phase 2 portion assessing the overall response to ENA alone demonstrated efficacy, with a composite complete response (cCR) rate (CR/CRi) of 46% in 60 evaluable patients. Seventeen patients subsequently transitioned to phase 1b combination therapy, with a cCR rate of 41% and 1 dose-limiting toxicity. Correlative studies highlight mechanisms of clonal elimination with differentiation therapy as well as therapeutic resistance. This study demonstrates both efficacy of ENA monotherapy in the upfront setting and feasibility and applicability of a risk-adapted approach to the upfront treatment of IDH2-mutant AML. This trial is registered at www.clinicaltrials.gov as #NCT03013998.

Published
2024

3. Samples from patients with AML show high concordance in detection of mutations by NGS at local institutions vs central laboratories.

Author

Borate, Uma, Yang, Fei, Press, Richard, Ruppert, Amy, Jones, Dan, Caruthers, Sean, Zhao, Weiqiang, Vergilio, Jo-Anne, Pavlick, Dean, Juckett, Luke, Norris, Brianna, Bucy, Taylor, Burd, Amy, Stein, Eytan, Patel, Prapti, Baer, Maria, Stock, Wendy, Blum, William, Kovacsovics, Tibor, Litzow, Mark, Foran, James, Heerema, Nyla, Rosenberg, Leonard, Marcus, Sonja, Yocum, Ashley, Stefanos, Mona, Druker, Brian, Byrd, John, Levine, Ross, Mims, Alice, and Schiller, Gary

Subjects
Humans, Nucleophosmin, Laboratories, Prognosis, Leukemia, Myeloid, Acute, Mutation, High-Throughput Nucleotide Sequencing
Abstract

Next-generation sequencing (NGS) to identify pathogenic mutations is an integral part of acute myeloid leukemia (AML) therapeutic decision-making. The concordance in identifying pathogenic mutations among different NGS platforms at different diagnostic laboratories has been studied in solid tumors but not in myeloid malignancies to date. To determine this interlaboratory concordance, we collected a total of 194 AML bone marrow or peripheral blood samples from newly diagnosed patients with AML enrolled in the Beat AML Master Trial (BAMT) at 2 academic institutions. We analyzed the diagnostic samples from patients with AML for the detection of pathogenic myeloid mutations in 8 genes (DNMT3A, FLT3, IDH1, IDH2, NPM1, TET2, TP53, and WT1) locally using the Hematologic Neoplasm Mutation Panel (50-gene myeloid indication filter) (site 1) or the GeneTrails Comprehensive Heme Panel (site 2) at the 2 institutions and compared them with the central results from the diagnostic laboratory for the BAMT, Foundation Medicine, Inc. The overall percent agreement was over 95% each in all 8 genes, with almost perfect agreement (κ > 0.906) in all but WT1, which had substantial agreement (κ = 0.848) when controlling for site. The minimal discrepancies were due to reporting variants of unknown significance (VUS) for the WT1 and TP53 genes. These results indicate that the various NGS methods used to analyze samples from patients with AML enrolled in the BAMT show high concordance, a reassuring finding given the wide use of NGS for therapeutic decision-making in AML.

Published
2023

5. The multi-CDK inhibitor dinaciclib reverses bromo- and extra-terminal domain (BET) inhibitor resistance in acute myeloid leukemia via inhibition of Wnt/β-catenin signaling

Author

Marr, Alexander R., Halpin, Madeline, Corbin, Dominique L., Asemelash, Yerdanos, Sher, Steven, Gordon, Britten K., Whipp, Ethan C., Mitchell, Shaneice, Harrington, Bonnie K., Orwick, Shelley, Benrashid, Samon, Goettl, Virginia M., Yildiz, Vedat, Mitchell, Andrew D., Cahn, Olivia, Mims, Alice S., Larkin, Karilyn T. M., Long, Meixao, Blachly, James, Woyach, Jennifer A., Lapalombella, Rosa, and Grieselhuber, Nicole R.

Published
2024
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6. Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial

Author

Duong, Vu H, Ruppert, Amy S, Mims, Alice S, Borate, Uma, Stein, Eytan M, Baer, Maria R, Stock, Wendy, Kovacsovics, Tibor, Blum, William, Arellano, Martha L, Schiller, Gary J, Olin, Rebecca L, Foran, James M, Litzow, Mark R, Lin, Tara L, Patel, Prapti A, Foster, Matthew C, Redner, Robert L, Al‐Mansour, Zeina, Cogle, Christopher R, Swords, Ronan T, Collins, Robert H, Vergilio, Jo‐Anne, Heerema, Nyla A, Rosenberg, Leonard, Yocum, Ashley O, Marcus, Sonja, Chen, Timothy, Druggan, Franchesca, Stefanos, Mona, Gana, Theophilus J, Shoben, Abigail B, Druker, Brian J, Burd, Amy, Byrd, John C, Levine, Ross L, and Boyiadzis, Michael M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Hematology, Pediatric, Rare Diseases, Childhood Leukemia, Clinical Research, Cancer, Orphan Drug, Aging, Pediatric Cancer, 6.1 Pharmaceuticals, Humans, Decitabine, Tumor Suppressor Protein p53, Leukemia, Myeloid, Acute, Karyotype, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, acute myeloid leukemia, decitabine, entospletinib, hypomethylating agents, tumor protein p53, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundPatients with acute myeloid leukemia (AML) who have tumor protein p53 (TP53) mutations or a complex karyotype have a poor prognosis, and hypomethylating agents are often used. The authors evaluated the efficacy of entospletinib, an oral inhibitor of spleen tyrosine kinase, combined with decitabine in this patient population.MethodsThis was a multicenter, open-label, phase 2 substudy of the Beat AML Master Trial (ClinicalTrials.gov identifier NCT03013998) using a Simon two-stage design. Eligible patients aged 60 years or older who had newly diagnosed AML with mutations in TP53 with or without a complex karyotype (cohort A; n = 45) or had a complex karyotype without TP53 mutation (cohort B; n = 13) received entospletinib 400 mg twice daily with decitabine 20 mg/m2 on days 1-10 every 28 days for up to three induction cycles, followed by up to 11 consolidation cycles, in which decitabine was reduced to days 1-5. Entospletinib maintenance was given for up to 2 years. The primary end point was complete remission (CR) and CR with hematologic improvement by up to six cycles of therapy.ResultsThe composite CR rates for cohorts A and B were 13.3% (95% confidence interval, 5.1%-26.8%) and 30.8% (95% confidence interval, 9.1%-61.4%), respectively. The median duration of response was 7.6 and 8.2 months, respectively, and the median overall survival was 6.5 and 11.5 months, respectively. The study was stopped because the futility boundary was crossed in both cohorts.ConclusionsThe combination of entospletinib and decitabine demonstrated activity and was acceptably tolerated in this patient population; however, the CR rates were low, and overall survival was short. Novel treatment strategies for older patients with TP53 mutations and complex karyotype remain an urgent need.

Published
2023

7. Sex-associated differences in frequencies and prognostic impact of recurrent genetic alterations in adult acute myeloid leukemia (Alliance, AMLCG)

Author

Ozga, Michael, Nicolet, Deedra, Mrózek, Krzysztof, Yilmaz, Ayse S., Kohlschmidt, Jessica, Larkin, Karilyn T., Blachly, James S., Oakes, Christopher C., Buss, Jill, Walker, Christopher J., Orwick, Shelley, Jurinovic, Vindi, Rothenberg-Thurley, Maja, Dufour, Annika, Schneider, Stephanie, Sauerland, Maria Cristina, Görlich, Dennis, Krug, Utz, Berdel, Wolfgang E., Woermann, Bernhard J., Hiddemann, Wolfgang, Braess, Jan, Subklewe, Marion, Spiekermann, Karsten, Carroll, Andrew J., Blum, William G., Powell, Bayard L., Kolitz, Jonathan E., Moore, Joseph O., Mayer, Robert J., Larson, Richard A., Uy, Geoffrey L., Stock, Wendy, Metzeler, Klaus H., Grimes, H. Leighton, Byrd, John C., Salomonis, Nathan, Herold, Tobias, Mims, Alice S., and Eisfeld, Ann-Kathrin

Published
2024
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8. Beat-AML 2024 ELN–refined risk stratification for older adults with newly diagnosed AML given lower-intensity therapy

Author

Hoff, Fieke W., Blum, William G., Huang, Ying, Welkie, Rina Li, Swords, Ronan T., Traer, Elie, Stein, Eytan M., Lin, Tara L., Archer, Kellie J., Patel, Prapti A., Collins, Robert H., Baer, Maria R., Duong, Vu H., Arellano, Martha L., Stock, Wendy, Odenike, Olatoyosi, Redner, Robert L., Kovacsovics, Tibor, Deininger, Michael W., Zeidner, Joshua F., Olin, Rebecca L., Smith, Catherine C., Foran, James M., Schiller, Gary J., Curran, Emily K., Koenig, Kristin L., Heerema, Nyla A., Chen, Timothy, Martycz, Molly, Stefanos, Mona, Marcus, Sonja G., Rosenberg, Leonard, Druker, Brian J., Levine, Ross L., Burd, Amy, Yocum, Ashley O., Borate, Uma M., Mims, Alice S., Byrd, John C., and Madanat, Yazan F.

Published
2024
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10. Outcome prediction by the 2022 European LeukemiaNet genetic-risk classification for adults with acute myeloid leukemia: an Alliance study

Author

Mrózek, Krzysztof, Kohlschmidt, Jessica, Blachly, James S., Nicolet, Deedra, Carroll, Andrew J., Archer, Kellie J., Mims, Alice S., Larkin, Karilyn T., Orwick, Shelley, Oakes, Christopher C., Kolitz, Jonathan E., Powell, Bayard L., Blum, William G., Marcucci, Guido, Baer, Maria R., Uy, Geoffrey L., Stock, Wendy, Byrd, John C., and Eisfeld, Ann-Kathrin

Published
2023
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12. Standardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts

Author

Shallis, Rory M, Daver, Naval, Altman, Jessica K, Komrokji, Rami S, Pollyea, Daniel A, Badar, Talha, Bewersdorf, Jan P, Bhatt, Vijaya R, de Botton, Stéphane, de la Fuente Burguera, Adolfo, Carraway, Hetty E, Desai, Pinkal, Dillon, Richard, Duployez, Nicolas, El Chaer, Firas, Fathi, Amir T, Freeman, Sylvie D, Gojo, Ivana, Grunwald, Michael R, Jonas, Brian A, Konopleva, Marina, Lin, Tara L, Mannis, Gabriel N, Mascarenhas, John, Michaelis, Laura C, Mims, Alice S, Montesinos, Pau, Pozdnyakova, Olga, Pratz, Keith W, Schuh, Andre C, Sekeres, Mikkael A, Smith, Catherine C, Stahl, Maximilian, Subklewe, Marion, Uy, Geoffrey L, Voso, Maria Teresa, Walter, Roland B, Wang, Eunice S, Zeidner, Joshua F, Žučenka, Andrius, and Zeidan, Amer M

Published
2023
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13. Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial

Author

Burd, Amy, Levine, Ross L, Ruppert, Amy S, Mims, Alice S, Borate, Uma, Stein, Eytan M, Patel, Prapti, Baer, Maria R, Stock, Wendy, Deininger, Michael, Blum, William, Schiller, Gary, Olin, Rebecca, Litzow, Mark, Foran, James, Lin, Tara L, Ball, Brian, Boyiadzis, Michael, Traer, Elie, Odenike, Olatoyosi, Arellano, Martha, Walker, Alison, Duong, Vu H, Kovacsovics, Tibor, Collins, Robert, Shoben, Abigail B, Heerema, Nyla A, Foster, Matthew C, Vergilio, Jo-Anne, Brennan, Tim, Vietz, Christine, Severson, Eric, Miller, Molly, Rosenberg, Leonard, Marcus, Sonja, Yocum, Ashley, Chen, Timothy, Stefanos, Mona, Druker, Brian, and Byrd, John C

Subjects
Cancer, Clinical Research, Childhood Leukemia, Rare Diseases, Pediatric, Genetics, Hematology, Pediatric Cancer, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Cytarabine, Daunorubicin, Female, Genomics, Humans, Leukemia, Myeloid, Acute, Male, Middle Aged, Mutation, Precision Medicine, Survival Analysis, Treatment Outcome, Medical and Health Sciences, Immunology
Abstract

Acute myeloid leukemia (AML) is the most common diagnosed leukemia. In older adults, AML confers an adverse outcome1,2. AML originates from a dominant mutation, then acquires collaborative transformative mutations leading to myeloid transformation and clinical/biological heterogeneity. Currently, AML treatment is initiated rapidly, precluding the ability to consider the mutational profile of a patient's leukemia for treatment decisions. Untreated patients with AML ≥ 60 years were prospectively enrolled on the ongoing Beat AML trial (ClinicalTrials.gov NCT03013998 ), which aims to provide cytogenetic and mutational data within 7 days (d) from sample receipt and before treatment selection, followed by treatment assignment to a sub-study based on the dominant clone. A total of 487 patients with suspected AML were enrolled; 395 were eligible. Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7 d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study. The remaining 171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment. Demographic, laboratory and molecular characteristics were not significantly different between patients on the Beat AML sub-studies and those receiving SOC (induction with cytarabine + daunorubicin (7 + 3 or equivalent) or hypomethylation agent). Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC. A precision medicine therapy strategy in AML is feasible within 7 d, allowing patients and physicians to rapidly incorporate genomic data into treatment decisions without increasing early death or adversely impacting overall survival.

Published
2020

16. Multi-site randomized trial of a collaborative palliative and oncology care model for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy.

Author

El-Jawahri, Areej, primary, Kavanaugh, Alison, additional, Greer, Joseph A., additional, Jackson, Vicki, additional, Gustin, Jillian, additional, Mims, Alice S., additional, Cook, Albert, additional, LeBlanc, Thomas William, additional, Choe, Joanna, additional, Reynolds, Mathew, additional, Fathi, Amir Tahmasb, additional, Hobbs, Gabriela, additional, Brunner, Andrew Mark, additional, and Temel, Jennifer S., additional

Published
2024
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18. Enasidenib as maintenance following allogeneic hematopoietic cell transplantation for IDH2-mutated myeloid malignancies

Author

Fathi, Amir T., Kim, Haesook T., Soiffer, Robert J., Levis, Mark J., Li, Shuli, Kim, Annette S., Mims, Alice S., DeFilipp, Zachariah, El-Jawahri, Areej, McAfee, Steven L., Brunner, Andrew M., Narayan, Rupa, Knight, Laura W., Kelley, Devon, Bottoms, AJ S., Perry, Lindsey H., Wahl, Jonathan L., Brock, Jennifer, Breton, Elayne, Ho, Vincent T., and Chen, Yi-Bin

Published
2022
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19. High early death rates, treatment resistance, and short survival of Black adolescents and young adults with AML

Author

Larkin, Karilyn T., Nicolet, Deedra, Kelly, Benjamin J., Mrózek, Krzysztof, LaHaye, Stephanie, Miller, Katherine E., Wijeratne, Saranga, Wheeler, Gregory, Kohlschmidt, Jessica, Blachly, James S., Mims, Alice S., Walker, Christopher J., Oakes, Christopher C., Orwick, Shelley, Boateng, Isaiah, Buss, Jill, Heyrosa, Adrienne, Desai, Helee, Carroll, Andrew J., Blum, William, Powell, Bayard L., Kolitz, Jonathan E., Moore, Joseph O., Mayer, Robert J., Larson, Richard A., Stone, Richard M., Paskett, Electra D., Byrd, John C., Mardis, Elaine R., and Eisfeld, Ann-Kathrin

Published
2022
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21. PP2A is a therapeutically targetable driver of cell fate decisions via a c-Myc/p21 axis in human and murine acute myeloid leukemia

Author

Goswami, Swagata, Mani, Rajeswaran, Nunes, Jessica, Chiang, Chi-Ling, Zapolnik, Kevan, Hu, Eileen, Frissora, Frank, Mo, Xiaokui, Walker, Logan A., Yan, Pearlly, Bundschuh, Ralf, Beaver, Larry, Devine, Raymond, Tsai, Yo-Ting, Ventura, Ann, Xie, Zhiliang, Chen, Min, Lapalombella, Rosa, Walker, Alison, Mims, Alice, Larkin, Karilyn, Grieselhuber, Nicole, Bennett, Chad, Phelps, Mitch, Hertlein, Erin, Behbehani, Gregory, Vasu, Sumithira, Byrd, John C., and Muthusamy, Natarajan

Published
2022
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22. White blood cell count levels are associated with inflammatory response and constitute independent outcome predictors in adult patients with acute myeloid leukemia aged <60 years.

Author

Ozga, Michael, Nicolet, Deedra, Mrózek, Krzysztof, Walker, Christopher J., Blachly, James S., Kohlschmidt, Jessica, Orwick, Shelley, Carroll, Andrew J., Larson, Richard A., Kolitz, Jonathan E., Powell, Bayard L., Stone, Richard M., Byrd, John C., Eisfeld, Ann‐Kathrin, and Mims, Alice S.

Published
2024
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23. Genomic analysis of cellular hierarchy in acute myeloid leukemia using ultrasensitive LC-FACSeq

Author

Saygin, Caner, Hu, Eileen, Zhang, Pu, Sher, Steven, Lozanski, Arletta, Doong, Tzyy-Jye, Nicolet, Deedra, Orwick, Shelley, Labanowska, Jadwiga, Skinner, Jordan N., Cempre, Casey, Kauffman, Tierney, Goettl, Virginia M., Heerema, Nyla A., Abruzzo, Lynne, Miller, Cecelia, Lapalombella, Rosa, Behbehani, Gregory, Mims, Alice S., Larkin, Karilyn, Grieselhuber, Nicole, Walker, Alison, Bhatnagar, Bhavana, Bloomfield, Clara D., Byrd, John C., Lozanski, Gerard, and Blachly, James S.

Published
2021
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24. Pyrimidine depletion enhances targeted and immune therapy combinations in acute myeloid leukemia

Author

Elgamal, Ola A., primary, Fobare, Sydney, additional, Vibhute, Sandip, additional, Mehmood, Abeera, additional, Vroom, Dennis C., additional, Johnson, Mariah L., additional, Stearns, Blaise, additional, Lerma, James R., additional, Truxall, Jean, additional, Stahl, Emily, additional, Carmichael, Bridget, additional, Orwick, Shelley J., additional, Mims, Alice S., additional, Curran, Emily, additional, Santhanam, Ramasamy, additional, Tridandapani, Susheela, additional, Phelps, Mitch A., additional, Xie, Zhiliang, additional, Coss, Christopher C., additional, Baker, Sharyn D., additional, Patrick, Jeffrey, additional, Ezzell, Janel K., additional, Rai, Jayesh, additional, Pan, Jianmin, additional, Rai, Shesh N., additional, Stillwell, Cody, additional, Wunderlich, Mark, additional, Abdulrahim, Mouad, additional, Goodwin, Thomas E., additional, Hilinski, Gerard, additional, Bennett, Chad E., additional, Hertlein, Erin, additional, and Byrd, John C., additional

Published
2024
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25. Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (m IDH1 ) acute myeloid leukemia (AML)

Author

Cortes, Jorge, primary, Jonas, Brian A., additional, Schiller, Gary, additional, Mims, Alice, additional, Roboz, Gail J., additional, Wei, Andrew H., additional, Montesinos, Pau, additional, Ferrell, P. Brent, additional, Yee, Karen WL., additional, Fenaux, Pierre, additional, Schwarer, Anthony, additional, and Watts, Justin M., additional

Published
2024
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26. Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial

Author

Rosenberg, Len, Levaux, Hugh, Levine, Ross L., Shah, Amit, Denmark, James, Hereema, Nyla, Owen, Melanie, Kalk, Spencer, Kenny, Nicholas, Vinson, Gene, Vergilio, Jo-Anne, Mims, Alice, Borate, Uma, Blum, William, Stein, Eytan, Gana, Theophilus J., Stefanos, Mona, Yocum, Ashley, Marcus, Sonja, Shoben, Abigail, Druker, Brian, Byrd, John, and Burd, Amy

Published
2021
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29. Determining the relationship of p16INK4a and additional molecular markers of aging with clinical frailty in hematologic malignancy.

Author

Rosko, Ashley E., Elsaid, Mohamed I., Woyach, Jennifer, Islam, Nowshin, Lepola, Noah, Urrutia, Jazmin, Christian, Lisa M., Presley, Carolyn, Mims, Alice, and Burd, Christin E.

Abstract

Purpose: Older adults with hematologic malignancies (HM) have unique challenges due to age and fitness. The primary aim of this pilot study was to benchmark the ability of multiple biomarkers of aging (p16, epigenetic clocks, T cell gene expression profiles, and T cell receptor excision circles (TREC) to identify frailty as measured by a clinical impairment index (I2) in patients with HM. Methods: 70 patients newly diagnosed with HM had peripheral blood T lymphocytes (PBTL) analyzed for p16INK4a expression using the OSU_Senescence Nanostring CodeSet. PBTL epigenetic age was measured using 7 epigenetic clocks, and TREC were quantified by qRT-PCR. A composite clinical impairment index (I2) was generated by combining values from 11 geriatric metrics (Independent Activities of Daily Living (iADL), physical health score, Short Physical Performance Battery (SPPB), Body Mass Index (BMI), Eastern Cooperative Oncology Group (ECOG) performance status, self-reported KPS, Blessed Orientation Memory Concentration (BOMC), polypharmacy, Mental Health Inventory (MHI)-17, Medical Outcomes Study (MOS) subscales). Clinical frailty was defined as a score of 7 or greater on the I2. Results: Age-adjusted p16INK4a was similar in newly diagnosed patients and healthy controls (p > 0.1). PBTL p16INK4a levels correlated positively with the Hannum [r = 0.35, 95% CI (0.09–0.75); p adj. = 0.04] and PhenoAge [r = 0.37, 95% CI (0.11–0.59); p adj. = 0.04] epigenetic clocks. The discrimination ability of the I2 model was calculated using the area under the receiver operating characteristic curve (AUC). After adjusting for chronologic age and disease group, baseline p16INK4a [AUC = 0.76, 95% CI (0.56–0.98); p = 0.01], Hannum [AUC = 0.70, 95% CI (0.54–0.85); p = 0.01], PhenoAge [AUC = 0.71, 95% CI (0.55–0.86); p = 0.01], and DunedinPACE [AUC = 0.73, 95% CI (0.57–0.88); p = < 0.01] measures showed the greatest potential to identify clinical frailty using the I2. Conclusions: Our pilot data suggest that multiple blood-based aging biomarkers have potential to identify frailty in older adults with HM. Implications for Cancer Survivors: We developed the I2 index to quantify impairments across geriatric domains and discovered that PBTL p16, Hannum, PhenoAge, and DunedinPACE are promising indicators of frailty in HM. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML).

Author

Cortes, Jorge, Jonas, Brian A., Schiller, Gary, Mims, Alice, Roboz, Gail J., Wei, Andrew H., Montesinos, Pau, Ferrell, P. Brent, Yee, Karen WL., Fenaux, Pierre, Schwarer, Anthony, and Watts, Justin M.

Subjects
ACUTE myeloid leukemia, ISOCITRATE dehydrogenase, VENETOCLAX
Abstract

Olutasidenib, a potent, selective, oral, mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor, is FDA-approved for relapsed/refractory (R/R) acute myeloid leukemia (AML). Here we report efficacy and safety of olutasidenib in 18 patients with mIDH1 AML who were relapsed (10), refractory (6) or had complete remission with incomplete hematologic recovery (CRi; 2) to a venetoclax combination. Of the 16 patients who were R/R, 4 (25%) achieved complete remission (CR), one (6.3%) achieved CR with partial hematologic recovery (CRh), and 7 (43.8%) achieved a composite complete remission (CRc). Median time to CRc was 1.9 months (range 1–2.8). As of data cutoff (18 June 2021), median duration of CRc was not reached (range, 1.2-NR, ongoing at 30.4+ months). Both patients with CRi at study entry achieved a CR. Safety was consistent with the overall profile of olutasidenib. Olutasidenib offers a valuable treatment option for patients with mIDH1 AML previously treated with venetoclax. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Molecular mechanisms mediating relapse following ivosidenib monotherapy in IDH1-mutant relapsed or refractory AML

Author

Choe, Sung, Wang, Hongfang, DiNardo, Courtney D., Stein, Eytan M., de Botton, Stéphane, Roboz, Gail J., Altman, Jessica K., Mims, Alice S., Watts, Justin M., Pollyea, Daniel A., Fathi, Amir T., Tallman, Martin S., Kantarjian, Hagop M., Stone, Richard M., Quek, Lynn, Konteatis, Zenon, Dang, Lenny, Nicolay, Brandon, Nejad, Parham, Liu, Guowen, Zhang, Vickie, Liu, Hua, Goldwasser, Meredith, Liu, Wei, Marks, Kevin, Bowden, Chris, Biller, Scott A., Attar, Eyal C., and Wu, Bin

Published
2020
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34. Additional gene mutations may refine the 2017 European LeukemiaNet classification in adult patients with de novo acute myeloid leukemia aged <60 years

Author

Eisfeld, Ann-Kathrin, Kohlschmidt, Jessica, Mims, Alice, Nicolet, Deedra, Walker, Christopher J., Blachly, James S., Carroll, Andrew J., Papaioannou, Dimitrios, Kolitz, Jonathan E., Powell, Bayard E., Stone, Richard M., de la Chapelle, Albert, Byrd, John C., Mrózek, Krzysztof, and Bloomfield, Clara D.

Published
2020
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35. A precision medicine classification for treatment of acute myeloid leukemia in older patients

Author

Mims, Alice S., Kohlschmidt, Jessica, Borate, Uma, Blachly, James S., Orwick, Shelley, Eisfeld, Ann-Kathrin, Papaioannou, Dimitrios, Nicolet, Deedra, Mrόzek, Krzysztof, Stein, Eytan, Bhatnagar, Bhavana, Stone, Richard M., Kolitz, Jonathan E., Wang, Eunice S., Powell, Bayard L., Burd, Amy, Levine, Ross L., Druker, Brian J., Bloomfield, Clara D., and Byrd, John C.

Published
2021
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36. Safety and efficacy of BAY1436032 in IDH1-mutant AML: phase I study results

Author

Heuser, Michael, Palmisiano, Neil, Mantzaris, Ioannis, Mims, Alice, DiNardo, Courtney, Silverman, Lewis R., Wang, Eunice S., Fiedler, Walter, Baldus, Claudia, Schwind, Sebastian, Pardee, Timothy, Perl, Alexander E., Cai, Charles, Kaulfuss, Stefan, Lagkadinou, Eleni, Rentzsch, Christine, Wagner, Markus, Wilkinson, Gary, Wu, Bingyan, Jeffers, Michael, Genvresse, Isabelle, and Krämer, Alwin

Published
2020
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40. Sex-associated differences in frequencies and prognostic impact of recurrent genetic alterations in adult acute myeloid leukemia (Alliance, AMLCG)

Author

Ozga, Michael, primary, Nicolet, Deedra, additional, Mrózek, Krzysztof, additional, Yilmaz, Ayse S., additional, Kohlschmidt, Jessica, additional, Larkin, Karilyn T., additional, Blachly, James S., additional, Oakes, Christopher C., additional, Buss, Jill, additional, Walker, Christopher J., additional, Orwick, Shelley, additional, Jurinovic, Vindi, additional, Rothenberg-Thurley, Maja, additional, Dufour, Annika, additional, Schneider, Stephanie, additional, Sauerland, Maria Cristina, additional, Görlich, Dennis, additional, Krug, Utz, additional, Berdel, Wolfgang E., additional, Woermann, Bernhard J., additional, Hiddemann, Wolfgang, additional, Braess, Jan, additional, Subklewe, Marion, additional, Spiekermann, Karsten, additional, Carroll, Andrew J., additional, Blum, William G., additional, Powell, Bayard L., additional, Kolitz, Jonathan E., additional, Moore, Joseph O., additional, Mayer, Robert J., additional, Larson, Richard A., additional, Uy, Geoffrey L., additional, Stock, Wendy, additional, Metzeler, Klaus H., additional, Grimes, H. Leighton, additional, Byrd, John C., additional, Salomonis, Nathan, additional, Herold, Tobias, additional, Mims, Alice S., additional, and Eisfeld, Ann-Kathrin, additional

Published
2023
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41. Improvement in survival of acute myeloid leukemia and myelodysplastic syndrome patients following allogeneic transplant: a long-term institutional experience

Author

Sigmund, Audrey M., primary, Jiang, Justin, additional, Zhao, Qiuhong, additional, Elder, Patrick, additional, Benson, Don M., additional, Vasu, Sumithira, additional, Jaglowski, Samantha, additional, Mims, Alice S., additional, Choe, Hannah, additional, Larkin, Karilyn, additional, Brammer, Jonathan E., additional, Wall, Sarah A., additional, Grieselhuber, Nicole, additional, Basem, William, additional, Penza, Sam, additional, Efebera, Yvonne A., additional, and Sharma, Nidhi, additional

Published
2023
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42. Phase 1 study of selinexor in combination with salvage chemotherapy in Adults with relapsed or refractory Acute myeloid leukemia

Author

Bhatnagar, Bhavana, primary, Zhao, Qiuhong, additional, Mims, Alice S., additional, Vasu, Sumithira, additional, Behbehani, Gregory K., additional, Larkin, Karilyn, additional, Blachly, James S., additional, Badawi, Mohamed A., additional, Hill, Kasey L., additional, Dzwigalski, Kyle R., additional, Phelps, Mitch A., additional, Blum, William, additional, Klisovic, Rebecca B., additional, Ruppert, Amy S., additional, Ranganathan, Parvathi, additional, Walker, Alison R., additional, and Garzon, Ramiro, additional

Published
2023
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43. POSTER: AML-068 Survival Differences in Patients With Acute Myeloid Leukemia (AML) Treated With Oral Azacitidine (Oral-AZA) as Maintenance and Those Eligible but Not Treated in a US Electronic Health Record (EHR) Database

Author

Mims, Alice, primary, Xie, Zhuoer, additional, Vasconcelos, Alberto, additional, Strocchia, Maria, additional, Heydendael, Willem, additional, Chevli, Manoj, additional, Rotter, David, additional, Potluri, Ravi, additional, Prebet, Thomas, additional, and Sieluk, Jan, additional

Published
2023
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46. Correction: Genomic analysis of cellular hierarchy in acute myeloid leukemia using ultrasensitive LC-FACSeq

Author

Saygin, Caner, Hu, Eileen, Zhang, Pu, Sher, Steven, Lozanski, Arletta, Doong, Tzyy-Jye, Nicolet, Deedra, Orwick, Shelley, Labanowska, Jadwiga, Skinner, Jordan N., Cempre, Casey, Kauffman, Tierney, Goettl, Virginia M., Heerema, Nyla A., Abruzzo, Lynne, Miller, Cecelia, Lapalombella, Rosa, Behbehani, Gregory, Mims, Alice S., Larkin, Karilyn, Grieselhuber, Nicole, Walker, Alison, Bhatnagar, Bhavana, Bloomfield, Clara D., Byrd, John C., Lozanski, Gerard, and Blachly, James S.

Published
2021
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48. P512: A PHASE 1B/2 STUDY OF TP-0903 AND DECITABINE TARGETING MUTANT TP53 AND/OR COMPLEX KARYOTYPE IN PATIENTS WITH UNTREATED ACUTE MYELOID LEUKEMIA (AML) ≥ AGE 60 YEARS: FINAL RESULTS

Author

Mims, Alice, primary, Huang, Ying, additional, Eisenmann, Eric, additional, Orwick, Shelley, additional, Buelow, Daelynn, additional, Swords, Ronan, additional, Zeidner, Joshua, additional, Foster, Matthew, additional, L. Lin, Tara, additional, Baer, Maria, additional, Madanat, Yazan, additional, Kovacsovics, Tibor, additional, Redner, Robert, additional, Al-Mansour, Zeina, additional, Stefanos, Mona, additional, Martycz, Molly, additional, Druggan, Franchesca, additional, Chen, Timothy, additional, Yocum, Ashley, additional, Borate, Uma, additional, Druker, Brian, additional, Burd, Amy, additional, Levine, Ross, additional, Baker, Sharyn, additional, and C. Byrd, John, additional

Published
2023
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49. S117: CHEMOTHERAPY-FREE TREATMENT WITH INOTUZUMAB OZOGAMICIN AND BLINATUMOMAB FOR OLDER ADULTS WITH NEWLY-DIAGNOSED, PH-NEGATIVE, CD22-POSITIVE, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: ALLIANCE A041703

Author

Wieduwilt, Matthew, primary, Yin, Jun, additional, Kour, Oudom, additional, Teske, Rebecca, additional, Stock, Wendy, additional, Byrd, Ken, additional, Doucette, Kimberly, additional, Mangan, James, additional, Masters, Gregory, additional, Mims, Alice, additional, Jamieson, Katarzyna, additional, Dinner, Shira, additional, Bseiso, Ali, additional, Uy, Geoffrey, additional, Erba, Harry, additional, Litzow, Mark, additional, and Stone, Richard, additional

Published
2023
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50. P354: MULTI-INSTITUTIONAL STUDY EVALUATING THE IMPACT ON SURVIVAL OF NEWER TREATMENT COMBINATIONS AND ALLOGENEIC STEM CELL TRANSPLANTATION IN PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA

Author

Badar, Talha, primary, Atallah, Ehab, additional, Narra, Ravi, additional, Mims, Alice, additional, Kota, Vamsi, additional, Desai, Shreya, additional, Sacchi de Camargo Correia, Guilherme, additional, Patel, Anand, additional, Duvall, Adam, additional, Palmisiano, Neil, additional, Curran, Emily, additional, Omer, Zulfa, additional, Shallis, Rory M., additional, Advani, Anjali, additional, and Litzow, Mark, additional

Published
2023
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