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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

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

Blood (2023) 142 (Supplement 1): 6205.

https://doi.org/10.1182/blood-2023-179195

Published: 2023

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

Blood (2023) 142 (Supplement 1): 3245.

https://doi.org/10.1182/blood-2023-178024

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

Blood (2023) 142 (Supplement 1): 4619.

https://doi.org/10.1182/blood-2023-188258

Published: 2023

Journal Articles

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

Blood (2023) 142 (Supplement 1): 1538.

https://doi.org/10.1182/blood-2023-173092

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

Blood (2023) 142 (Supplement 1): 1439.

https://doi.org/10.1182/blood-2023-186712

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

Blood (2023) 142 (Supplement 1): 7296.

https://doi.org/10.1182/blood-2023-179664

Published: 2023

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

Blood (2022) 140 (Supplement 1): 12341–12342.

https://doi.org/10.1182/blood-2022-165534

Published: 2022

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

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

Blood (2022) 140 (Supplement 1): 9779–9780.

https://doi.org/10.1182/blood-2022-158276

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

Blood (2022) 140 (Supplement 1): 12033–12034.

https://doi.org/10.1182/blood-2022-158650

Published: 2022

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

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

Blood (2021) 138 (Supplement 1): 66.

https://doi.org/10.1182/blood-2021-144648

Published: 2021

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)

Blood (2021) 138 (Supplement 1): 2344.

https://doi.org/10.1182/blood-2021-147769

Published: 2021

Journal Articles

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

Blood (2021) 138 (Supplement 1): 3682.

https://doi.org/10.1182/blood-2021-154179

Published: 2021

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

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

Blood (2020) 136 (Supplement 1): 29–30.

https://doi.org/10.1182/blood-2020-134272

Published: 2020

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

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)

Blood (2020) 136 (Supplement 1): 37–38.

https://doi.org/10.1182/blood-2020-133855

Published: 2020

NARROW

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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American Society of Hematology

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American Society of Hematology

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