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Journal Articles

The conundrum of drug development in higher-risk MDS: Lessons learned from recently failed phase 3 clinical trials

Maximilian F. Stahl, Amer M. Zeidan

Blood blood.2025029727.

https://doi.org/10.1182/blood.2025029727

Published: 2025

Journal Articles

Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement

Uma Borate, Kelly Pugh, Allyson Waller, Rina Li Welkie, Ying Huang, Jan Philipp Bewersdorf, Maximilian Stahl, Amy E. DeZern, Uwe Platzbecker, Mikkael A. Sekeres, Andrew H. Wei, Rena J. Buckstein, Gail J. Roboz, Michael R. Savona, Sanam Loghavi, Robert P. Hasserjian, Pierre Fenaux, David A. Sallman, Christopher S. Hourigan, Matteo Giovanni Della Porta, Stephen Nimer, Richard F. Little, Valeria Santini, Fabio Efficace, Justin Taylor, Guillermo Garcia-Manero, Olatoyosi Odenike, Tae Kon Kim, Stephanie Halene, Rami S. Komrokji, Elizabeth A. Griffiths, Peter L. Greenberg, Mina L. Xu, Zhuoer Xie, Rafael Bejar, Guillermo F. Sanz, Mrinal M. Patnaik, Maria Figueroa, Hetty E. Carraway, Omar Abdel-Wahab, Daniel Starczynowski, Eric Padron, Jacqueline Boultwood, Steven Gore, Naval G. Daver, Jane E. Churpek, Ravindra Majeti, John M. Bennett, Alan F. List, Andrew M. Brunner, Amer M. Zeidan

Blood (2025) 145 (13): 1369–1381.

https://doi.org/10.1182/blood.2023023717

Published: 2025

Includes: Supplemental data

Journal Articles

Risk prediction for clonal cytopenia: multicenter real-world evidence

Blood (2024) 144 (19): 2033–2044.

https://doi.org/10.1182/blood.2024024756

Published: 2024

Includes: Supplemental data

Journal Articles

A Phase 2B, Open-Label Multicenter Study of Tebapivat (AG-946), a Potent Pyruvate Kinase Activator, in Patients with Anemia Due to Lower-Risk Myelodysplastic Syndromes

Amer M. Zeidan, Mikkael A. Sekeres, Hanny Al-Samkari, Hetty E. Carraway, Amy E. DeZern, Moshe Mittelman, Meredith Little, Vanessa Beynon, Xiaoshu Dai, Sal Sommakia, Jenny M. Despotovic, Parija Patel, Melissa Dibacco, Bruno Fattizzo, Eytan M. Stein, David Sallman, Austin G. Kulasekararaj, Uwe Platzbecker, Pierre Fenaux

Blood (2024) 144 (Supplement 1): 6708.

https://doi.org/10.1182/blood-2024-203073

Published: 2024

Journal Articles

The Implication of TP53 Allelic Status for Outcome and Erythropoiesis in MDS

Bing Li, Yanping Zeng, Chengwen Li, Jinqin Liu, Ge Song, Yao Yao, Amer M. Zeidan, Zhijian Xiao

Blood (2024) 144 (Supplement 1): 6707.

https://doi.org/10.1182/blood-2024-205429

Published: 2024

Journal Articles

Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205)

Amer M. Zeidan, Hongyan Tong, Zhijian Xiao, Praneeth Baratam, Ramzi Abboud, Christopher B. Benton, Joshua F Zeidner, Uma Borate, Wanxing Chai-Ho, Yonglin Lu, Jie Yang, Mingxiu Hu, Baiyong Li, Michelle Xia, David Sallman

Blood (2024) 144 (Supplement 1): 6705.

https://doi.org/10.1182/blood-2024-200541

Published: 2024

Journal Articles

Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia

Blood (2024) 144 (Supplement 1): 1504.3.

https://doi.org/10.1182/blood-2024-205101

Published: 2024

Journal Articles

Cost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States

Kunal C Potnis, Satoko Ito, Kishan Patel, Rory M. Shallis, Nikolai A. Podoltsev, Tariq Kewan, Jessica M. Stempel, Lourdes Mendez, Scott F Huntington, Maximilian Stahl, Amer M. Zeidan, Jan Philipp Bewersdorf, George Goshua

Blood (2024) 144 (Supplement 1): 3644.

https://doi.org/10.1182/blood-2024-204312

Published: 2024

Journal Articles

Generation of Multimodal Longitudinal Synthetic Data By Artificial Intelligence to Improve Personalized Medicine in Hematology

Blood (2024) 144 (Supplement 1): 4981.

https://doi.org/10.1182/blood-2024-209541

Published: 2024

Journal Articles

Artificial Intelligence-Powered Digital Pathology to Improve Diagnosis and Personalized Prognostic Assessment in Patient with Myeloid Neoplasms

Blood (2024) 144 (Supplement 1): 3598.

https://doi.org/10.1182/blood-2024-206248

Published: 2024

Journal Articles

Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)

Blood (2024) 144 (Supplement 1): 3228.1.

https://doi.org/10.1182/blood-2024-200797

Published: 2024

Journal Articles

Landscape of Immune Cell States and Ecosystems in Patients with Myelodysplastic Syndrome to Refine Prognostic Assessment and Predict Treatment Response. a Study By i4MDS Consortium

Blood (2024) 144 (Supplement 1): 665.

https://doi.org/10.1182/blood-2024-200184

Published: 2024

Journal Articles

Impact of Response to Hypomethylating Agent-Based Therapy on Survival Outcomes in the Context of Baseline Clinical-Molecular Risk and Transplant Status in Patients with Myelodysplastic Syndromes/Neoplasms (MDS): An Analysis from the International Consortium for MDS (icMDS) Validate Database

Benjamin Rolles, Jan Philipp Bewersdorf, Tariq Kewan, Ondrej Blaha, Jessica M. Stempel, Luca Lanino, Najla H. Al Ali, Amy E. DeZern, Mikkael A. Sekeres, Geoffrey L. Uy, Hetty E. Carraway, Pinkal Desai, Elizabeth A. Griffiths, Eytan M. Stein, Andrew M. Brunner, Christine M. McMahon, Rory M. Shallis, Joshua F Zeidner, Michael R. Savona, Stacey M. Frumm, Shougat Barua, Namrata S. Chandhok, Constantine Logothetis, Aram Bidikian, Ted M. Getz, Gail J. Roboz, Eunice S. Wang, Amyah C. Harris, Maria L Amaya, Hayley Hawkins, Somedeb Ball, Justin Grenet, Zhuoer Xie, Yazan F Madanat, Yasmin Abaza, Talha Badar, Torsten Haferlach, Jaroslaw Maciejewski, David Sallman, Anoop K Enjeti, Kamal Al-Rabi, Khalid Halahleh, Devendra Hiwase, Maria Diez-Campelo, David Valcarcel, Claudia Haferlach, Lisa Pleyer, Ioannis Kotsianidis, Vassiliki Pappa, Valeria Santini, Angela Consagra, Aref Al-Kali, Seishi Ogawa, Yasuhito Nannya, Matteo Giovanni Della Porta, Rami S. Komrokji, Amer M. Zeidan, Maximilian Stahl

Blood (2024) 144 (Supplement 1): 664.

https://doi.org/10.1182/blood-2024-208034

Published: 2024

Journal Articles

Results from a Phase 1 Open-Label Dose Escalation and Expansion Trial of Oral Azacitidine + Cedazuridine (ASTX030) in Patients with Myelodysplastic Syndromes (MDS) and MDS/Myeloproliferative Neoplasms (MPN)

Guillermo Garcia-Manero, James McCloskey, Bart L. Scott, Elizabeth A. Griffiths, Bonnie Kiner-Strachan, Andrew M. Brunner, Amer M. Zeidan, Elie Traer, Yazan F. Madanat, Janelle Meyer, Harry Erba, Praneeth Baratam, Uma Borate, Yuri Sano, Aram Oganesian, Lixia Zhu, Harold N. Keer, Michael R. Savona

Blood (2024) 144 (Supplement 1): 662.

https://doi.org/10.1182/blood-2024-203569

Published: 2024

Journal Articles

Oral Decitabine/Cedazuridine in Patients with MDS and TP53 Mutations: A Propensity Score Matching Analysis from the Phase II and III Trials

Samuel Urrutia, Koji Sasaki, Alex Bataller, Hagop M. Kantarjian, Guillermo Montalban-Bravo, James McCloskey, Elizabeth A. Griffiths, Karen Yee, Amer M. Zeidan, Michael R. Savona, Aram Oganesian, Yuri Sano, Harold N. Keer, Guillermo Garcia-Manero

Blood (2024) 144 (Supplement 1): 661.

https://doi.org/10.1182/blood-2024-193274

Published: 2024

Journal Articles

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1- m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007

Blood (2024) 144 (Supplement 1): 214.

https://doi.org/10.1182/blood-2024-198218

Published: 2024

Journal Articles

Enhancing Personalized Prognostic Assessment of Myelodysplastic Syndromes through a Multimodal and Explainable Deep Data Fusion Approach (MAGAERA)

Blood (2024) 144 (Supplement 1): 105.

https://doi.org/10.1182/blood-2024-205413

Published: 2024

Journal Articles

A Molecular-Based Ecosystem to Improve Personalized Medicine in Patients with Chronic Myelomonocytic Leukemia (CMML)

Luca Lanino, Anthony M. Hunter, Nico Gagelmann, Marie Robin, Claudia Sala, Daniele Dall'Olio, Carmelo Gurnari, Lorenzo Dall'Olio, Yu-Hung Wang, Lisa Pleyer, Blanca Xicoy, Guillermo Montalban-Bravo, Lee-Yung Shih, Tamanna Haque, Omar Abdel-Wahab, Klaus Geissler, Alex Bataller, Alexandre Bazinet, Manja Meggendorfer, Ilaria Carola Casetti, Elisabetta Sauta, Erica Travaglino, Laura Palomo, Lurdes Zamora, David Quintela, Andres Jerez, Elena Cornejo, Paloma Garcia Martin, Marina Díaz-Beyá, Alejandro Avendaño Pita, Veronica Roldan, Dolly Viviana Fiallo Suarez, Estefania Cerezo Velasco, Marisa Calabuig, Esperanza Such, Guillermo Sanz, Anne Sophie Kubasch, Cristina Castilla-Llorente, Claude-Éric Bulabois, Laetitia Souchet, Hussein Awada, Massimo Bernardi, Patrizia Chiusolo, Antonio Curti, Luisa Giaccone, Francesco Onida, Lorenza Maria Borin, Francesco Passamonti, Elisa Diral, Vladan Vucinic, Gregorio Maria Bergonzi, Maria Teresa Voso, Hsin-An Hou, Wen-Chien Chou, Chi-Yuan Yao, Chien-Chin Lin, Hwei-Fang Tien, Alessia Campagna, Marta Ubezio, Antonio Russo, Gabriele Todisco, Giulia Maggioni, Cristina Astrid Tentori, Alessandro Buizza, Gianluca Asti, Matteo Zampini, Elena Riva, Mattia Delleani, Angela Consagra, Francesca Ficara, Armando Santoro, Luciana Carota, Tiziana Sanavia, Cesare Rollo, Ahmad Kiwan, Jennifer VanOudenhove, Piero Fariselli, Najla H. Al Ali, David Sallman, Wolfgang Kern, Guillermo Garcia-Manero, Swapna Thota, Elizabeth A. Griffiths, Matilde Yung Follo, Carlo Finelli, Uwe Platzbecker, Francesc Sole, Maria Diez-Campelo, Jaroslaw Maciejewski, Rafael Bejar, Felicitas R. Thol, Nicolaus Kröger, Pierre Fenaux, Raphael Itzykson, Timothy Aaron Graubert, Michaela Fontenay, Amer M. Zeidan, Rami S. Komrokji, Valeria Santini, Torsten Haferlach, Ulrich Germing, Saverio D'Amico, Gastone Castellani, Mrinal M. Patnaik, Eric Solary, Eric Padron, Matteo Giovanni Della Porta

Blood (2024) 144 (Supplement 1): 1003.

https://doi.org/10.1182/blood-2024-200104

Published: 2024

Journal Articles

Drug Development for Hematological Cancer Targets Using Asclepius

Davide Crucitti, Carlos Pérez Míguez, Manuel Piñeiro Fiel, Jose Angel Diaz Arias, Jesús Gómez Fernández, Adrian Mosquera Orgueira, Amer M. Zeidan

Blood (2024) 144 (Supplement 1): 7464.

https://doi.org/10.1182/blood-2024-198610

Published: 2024

Journal Articles

Validation of Recent Response Criteria (ELN-22, IWG-23 and PB-CR) in 1634 MDS/CMML/AML Patients Treated with HMA or HMA-Ven Using CPH Models and a CPH Deep Neural Network - Can or Should Response Criteria be Harmonized for Similarly Treated Patients?

Blood (2024) 144 (Supplement 1): 7511.

https://doi.org/10.1182/blood-2024-208073

Published: 2024

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The conundrum of drug development in higher-risk MDS: Lessons learned from recently failed phase 3 clinical trials

Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement

Risk prediction for clonal cytopenia: multicenter real-world evidence

A Phase 2B, Open-Label Multicenter Study of Tebapivat (AG-946), a Potent Pyruvate Kinase Activator, in Patients with Anemia Due to Lower-Risk Myelodysplastic Syndromes

The Implication of TP53 Allelic Status for Outcome and Erythropoiesis in MDS

Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205)

Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia

Cost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States

Generation of Multimodal Longitudinal Synthetic Data By Artificial Intelligence to Improve Personalized Medicine in Hematology

Artificial Intelligence-Powered Digital Pathology to Improve Diagnosis and Personalized Prognostic Assessment in Patient with Myeloid Neoplasms

Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)

Landscape of Immune Cell States and Ecosystems in Patients with Myelodysplastic Syndrome to Refine Prognostic Assessment and Predict Treatment Response. a Study By i4MDS Consortium

Impact of Response to Hypomethylating Agent-Based Therapy on Survival Outcomes in the Context of Baseline Clinical-Molecular Risk and Transplant Status in Patients with Myelodysplastic Syndromes/Neoplasms (MDS): An Analysis from the International Consortium for MDS (icMDS) Validate Database

Results from a Phase 1 Open-Label Dose Escalation and Expansion Trial of Oral Azacitidine + Cedazuridine (ASTX030) in Patients with Myelodysplastic Syndromes (MDS) and MDS/Myeloproliferative Neoplasms (MPN)

Oral Decitabine/Cedazuridine in Patients with MDS and TP53 Mutations: A Propensity Score Matching Analysis from the Phase II and III Trials

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1- m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007

Enhancing Personalized Prognostic Assessment of Myelodysplastic Syndromes through a Multimodal and Explainable Deep Data Fusion Approach (MAGAERA)

A Molecular-Based Ecosystem to Improve Personalized Medicine in Patients with Chronic Myelomonocytic Leukemia (CMML)

Drug Development for Hematological Cancer Targets Using Asclepius

Validation of Recent Response Criteria (ELN-22, IWG-23 and PB-CR) in 1634 MDS/CMML/AML Patients Treated with HMA or HMA-Ven Using CPH Models and a CPH Deep Neural Network - Can or Should Response Criteria be Harmonized for Similarly Treated Patients?

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