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Harold N. Keer
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Journal Articles

Development of Oral Azacitidine with Cedazuridine for Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) Including CMML (Chronic Myelomonocytic Leukemia) By Targeting Pharmacokinetic AUC Equivalence Vs Subcutaneous Azacitidine

Guillermo Garcia-Manero, James McCloskey, Bart L. Scott, Elizabeth A. Griffiths, Bonnie Kiner-Strachan, Gail J. Roboz, Janelle Meyer, Winny Chan, Beloo Mirakhur, Yuri Sano, Aram Oganesian, Harold N. Keer, Michael R. Savona
Journal: Blood
Blood (2023) 142 (Supplement 1): 3245.
https://doi.org/10.1182/blood-2023-178024
Published: 2023
Journal Articles

Epigenetic Priming By Hypomethylation Enhances the Immunogenic Potential of Tolinapant in T-Cell Lymphoma

George Ward, Zhiqiang Zhang, Simone Jueliger, Ilya Potapov, Matthew P Davis, Adam Boxall, Jason A Taylor, Harold N. Keer, Andrea Biondo, John F Lyons, Martin Sims, Tomoko Smyth
Journal: Blood
Blood (2023) 142 (Supplement 1): 1439.
https://doi.org/10.1182/blood-2023-186712
Published: 2023
Journal Articles

Reclassification of Ascertain (ASTX727-02) Myelodysplastic Syndrome (MDS) Patients: Outcomes Including Clinical Response, Overall Survival (OS), and Leukemia Free Survival (LFS) Based on IPSS-R and IPSS-M Scoring Systems

Guillermo Garcia-Manero, James McCloskey, Elizabeth A. Griffiths, Amer M. Zeidan, Karen W.L. Yee, Aref Al-Kali, H. Joachim Deeg, Prapti A. Patel, Mitchell Sabloff, Mary-Margaret Keating, Nancy Zhu, Nashat Y. Gabrail, Salman Fazal, Joseph J. Maly, Olatoyosi Odenike, Hagop M. Kantarjian, Amy E. DeZern, Casey L. O'Connell, Gail J. Roboz, Lambert Busque, Rena Buckstein, Harsh Amin, Jasleen K. Randhawa, Brian Leber, Shannon Lee, Winny Chan, Sonia Souza, Yuri Sano, Harold N. Keer, Michael R. Savona
Journal: Blood
Blood (2023) 142 (Supplement 1): 4619.
https://doi.org/10.1182/blood-2023-188258
Published: 2023
Journal Articles

Phase 3b Study Design for a Comparison of Treatment Preference between Oral Decitabine/Cedazuridine and Azacitidine in Adult Patients with IPSS-R Intermediate Myelodysplastic Syndrome, IPSS Intermediate-2 or High-Risk Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukaemia, or Chronic Myelomonocytic Leukaemia

Anoop K Enjeti, Chun Yew Fong, Francesco Castaldi, Greg van Wyk, Richard Walton, Taliesha Paine, Harold N. Keer
Journal: Blood
Blood (2023) 142 (Supplement 1): 7296.
https://doi.org/10.1182/blood-2023-179664
Published: 2023
Journal Articles

ASTX660-01 Phase 2: A Case Study of Tolinapant-Induced Pseudoprogression in CTCL

Brian Poligone, Simone Jueliger, Matthew P Davis, Ilya Potapov, George Ward, Tomoko Smyth, Jason A Taylor, Harold N. Keer, Martin Sims
Journal: Blood
Blood (2023) 142 (Supplement 1): 6205.
https://doi.org/10.1182/blood-2023-179195
Published: 2023
Journal Articles

Oral Decitabine/Cedazuridine Vs Intravenous Decitabine for Acute Myeloid Leukemia: Final Results of a Randomized, Crossover, Registration-Enabling, Pharmacokinetics Study

Klaus Geissler, Zdenek Koristek, Teresa Bernal Del Castillo, Jan Novak, Gabriela Rodriguez Macias, Stephan Metzelder, Arpad Illes, Agnes Nagy, Jiří Mayer, Montserrat Arnan Sangerman, Mary-Margaret Keating, Jürgen Krauter, Monia Lunghi, Nicola Fracchiolla, Uwe Platzbecker, Valeria Santini, Danna Chan, Beloo Mirakhur, Yuri Sano, Aram Oganesian, Harold N. Keer, Michael Lübbert
Journal: Blood
Blood (2023) 142 (Supplement 1): 1538.
https://doi.org/10.1182/blood-2023-173092
Published: 2023
Journal Articles

ASTX727-03: Phase 1 Study Evaluating Oral Decitabine/Cedazuridine (ASTX727) Low-Dose (LD) in Lower-Risk Myelodysplastic Syndromes (LR-MDS) Patients

Guillermo Garcia-Manero, Kimo Bachiashvili, Harshad Amin, Elie Traer, Daniel A. Pollyea, David A. Sallman, Aref Al-Kali, Larry D. Cripe, Jesus G Berdeja, Elizabeth A. Griffiths, Sanjay R Mohan, Yuri Sano, Aram Oganesian, Harold N. Keer, Abdulraheem Yacoub
Journal: Blood
Blood (2022) 140 (Supplement 1): 1112–1114.
https://doi.org/10.1182/blood-2022-156512
Published: 2022
Journal Articles

Phase 2 Study of Oral Decitabine/Cedazuridine in Combination with Magrolimab for Previously Untreated Subjects with Intermediate to Very High-Risk Myelodysplastic Syndromes (MDS)

Amer M. Zeidan, Karen Mosher, Sonia Souza, Beloo Mirakhur, Harold N. Keer, Jason A. Taylor
Journal: Blood
Blood (2022) 140 (Supplement 1): 9779–9780.
https://doi.org/10.1182/blood-2022-158276
Published: 2022
Journal Articles

Real-World Study Real-World Study of the Use of Azacitidine in Myelodysplasia in Australia

Anoop Enjeti, Asma Ashraf, Vincent Caillet, Arif Alam, Jonathan Robert Sillar, Francesco Castaldi, Taliesha Paine, Harold N. Keer
Journal: Blood
Blood (2022) 140 (Supplement 1): 12341–12342.
https://doi.org/10.1182/blood-2022-165534
Published: 2022
Journal Articles

A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

Jake Shortt, Brian Poligone, Vincent Ribrag, Pier Luigi Zinzani, Dima El-Sharkawi, Jan Walewski, Anca Prica, Laksmi Wilson, Sonia Souza, Harold N. Keer, Jason A. Taylor, Enrica Marchi
Journal: Blood
Blood (2022) 140 (Supplement 1): 12033–12034.
https://doi.org/10.1182/blood-2022-158650
Published: 2022
Journal Articles

Results from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 302 Patients with Relapsed or Refractory (r/r) Acute Myeloid Leukemia after Intensive Chemotherapy (ASTRAL-2 Study)

Gail J. Roboz, Guillermo Sanz, Elizabeth A. Griffiths, Karen Yee, Hagop Kantarjian, Christian Recher, Michael T. Byrne, Elzbieta Patkowska, Hee-Je Kim, Xavier Thomas, Ine Moors, Wendy Stock, Arpad Illes, Pierre Fenaux, Yasushi Miyazaki, Takahiro Yamauchi, Casey L. O'Connell, Yong Hao, Harold N. Keer, Mohammad Azab, Hartmut Dohner
Journal: Blood
Blood (2021) 138 (Supplement 1): 2344.
https://doi.org/10.1182/blood-2021-147769
Published: 2021
Journal Articles

A Phase 1 Study Evaluating ASTX727 (decitabine and cedazuridine) and Venetoclax Combination Therapy in Newly Diagnosed AML Patients Unfit for Intensive Induction Chemotherapy

Gabriel N. Mannis, Elizabeth A. Griffiths, Michael R. Savona, Olatoyosi Odenike, Gail J. Roboz, Casey L. O'Connell, Jacqueline Dillingham, Prieya Wason, Lixia Zhu, Danna Chan, Harold N. Keer, Aram Oganesian, Kim-Hien Dao, Courtney D. DiNardo
Journal: Blood
Blood (2021) 138 (Supplement 1): 1245.
https://doi.org/10.1182/blood-2021-146264
Published: 2021
Journal Articles

Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study

Guillermo Garcia-Manero, James K McCloskey, Elizabeth A. Griffiths, Karen Yee, Amer M. Zeidan, Aref Al-Kali, H. Joachim Deeg, Prapti Patel, Mitchell Sabloff, Mary-Margaret Keating, Kim-Hien Dao, Nancy Zhu, Nashat Y. Gabrail, Salman Fazal, Joseph Maly, Olatoyosi Odenike, Hagop Kantarjian, Amy E. DeZern, Casey L. O'Connell, Gail J. Roboz, Lambert Busque, Richard A. Wells, Harshad Amin, Jasleen K. Randhawa, Brian Leber, Yong Hao, Harold N. Keer, Mohammad Azab, Michael R. Savona
Journal: Blood
Blood (2021) 138 (Supplement 1): 66.
https://doi.org/10.1182/blood-2021-144648
Published: 2021
Journal Articles

Efficacy of Oral Decitabine/Cedazuridine (ASTX727) in the CMML Subgroup from the Ascertain Phase 3 Study

Michael R. Savona, James K McCloskey, Elizabeth A. Griffiths, Karen Yee, Amer M. Zeidan, Aref Al-Kali, H. Joachim Deeg, Prapti Patel, Mitchell Sabloff, Mary-Margaret Keating, Kim-Hien Dao, Nancy Zhu, Nashat Gabrail, Salman Fazal, Joseph Maly, Olatoyosi Odenike, Hagop Kantarjian, Amy E. DeZern, Casey L. O'Connell, Gail J. Roboz, Lambert Busque, Richard A. Wells, Harshad Amin, Jasleen K. Randhawa, Brian Leber, Yong Hao, Harold N. Keer, Mohammad Azab, Guillermo Garcia-Manero
Journal: Blood
Blood (2021) 138 (Supplement 1): 3682.
https://doi.org/10.1182/blood-2021-154179
Published: 2021
Journal Articles

Anti-Tumor Activity of ASTX029, a Dual Mechanism Inhibitor of ERK1/2, in Preclinical AML Models

Christopher J. Hindley, PhD, Lynsey Fazal, BSc, Joanne M. Munck, PhD, Vanessa Martins, BSc, Alpesh D. Shah, MSci, Nicola E. Wilsher, PhD, Nicola G. Wallis, PhD, Harold N. Keer, MDPhD, John F. Lyons, PhD
Journal: Blood
Blood (2020) 136 (Supplement 1): 7–8.
https://doi.org/10.1182/blood-2020-139175
Published: 2020
Journal Articles

Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Michael R. Savona, MD, James K. McCloskey, MD, Elizabeth A. Griffiths, MD, Karen W.L. Yee, MD, Aref Al-Kali, MD, Amer M. Zeidan, MBBS, MHS, H. Joachim Deeg, MD, Prapti A. Patel, MD, Mitchell Sabloff, MSc,MDFRCPC, Mary-Margaret Keating, MD FRCPC, Kim-Hien Dao, DO, PhD, Nancy Zhu, MD, Nashat Gabrail, MD, Salman Fazal, MD, Joseph Maly, MD, Olatoyosi Odenike, MD, Hagop M. Kantarjian, MD, Amy E. DeZern, MD, Casey L. O'Connell, MD, Gail J. Roboz, MD, Lambert Busque, MD, Richard A. Wells, MD DPhil, Harshad Amin, MD, Jasleen K. Randhawa, MD, Brian Leber, MD, Yong Hao, MD PhD, Harold N. Keer, MDPhD, Mohammad Azab, MD, Guillermo Garcia-Manero, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 37–38.
https://doi.org/10.1182/blood-2020-133855
Published: 2020
Journal Articles

Minimal Residual Disease Eradication with Guadecitabine (SGI-110) in the Post-Transplant Setting

Betul Oran, MDMS, Amin M. Alousi, MD, Rohtesh S. Mehta, MDMPH,MS, David Marin, Partow Kebriaei, MD, Uday R. Popat, MD, Amanda L. Olson, Jessica M McCarty, RN, Jennifer D Ramos, RN, Roland Bassett, Harold N. Keer, MDPhD, Peter F Thall, PhD, Richard E. Champlin, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 10–11.
https://doi.org/10.1182/blood-2020-134204
Published: 2020
Journal Articles

Maintenance Treatment with Guadecitabine (SGI-110) in High Risk MDS and AML Patients after Allogeneic Stem Cell Transplantation

Betul Oran, MDMS, Gheath Alatrash, Amin M. Alousi, MD, Rohtesh S. Mehta, MDMPH,MS, Chitra Hosing, MD, Uday R. Popat, MD, Jin S. Im, Jessica M McCarty, RN, Jennifer D Ramos, RN, Harold N. Keer, MDPhD, Peter F Thall, PhD, Richard E. Champlin, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 29–30.
https://doi.org/10.1182/blood-2020-134272
Published: 2020
Journal Articles

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

Guillermo Garcia-Manero, MD, James McCloskey, MD, Elizabeth A. Griffiths, MD, Karen W.L. Yee, MD, Amer M. Zeidan, MBBS, MHS, Aref Al-Kali, MD, Kim-Hien Dao, DO, PhD, H. Joachim Deeg, MD, Prapti A. Patel, MD, Mitchell Sabloff, MSc,MDFRCPC, Mary-Margaret Keating, MD, Nancy Zhu, MD, Nashat Y. Gabrail, MD, Salman Fazal, MD, Joseph Maly, MD, Olatoyosi Odenike, MD, Aditi Shastri, MD, Amy E. DeZern, MD, Casey L. O'Connell, MD, Gail J. Roboz, MD, Aram Oganesian, PhD, Yong Hao, MD PhD, Harold N. Keer, MD PhD, Mohammad Azab, MD, Michael R. Savona, MD
Journal: Blood
Blood (2019) 134 (Supplement_1): 846.
https://doi.org/10.1182/blood-2019-122980
Published: 2019