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Journal Articles

Estimand Framework in AML Based on a Randomized, Placebo-Controlled, Phase 3 Study Investigating the Effect of Adding Midostaurin to Standard Chemotherapy in Patients with Newly Diagnosed AML without a FLT3 Mutation

Bourras-Rezki Bengoudifa, Hans Weber, PhD, Insa Gathmann, Albert Hoenekopp, MD, Noah Berkowitz, MD PhD

Blood (2018) 132 (Supplement 1): 5196.

https://doi.org/10.1182/blood-2018-99-119394

Published: 2018

Journal Articles

Impact of Somatic Gene Mutations on Response to Lenalidomide (LEN) in IPSS Lower-Risk Myelodysplastic Syndromes (MDS) Patients (Pts) without Del(5q) and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents (ESAs)

Valeria Santini, MD, Pierre Fenaux, MD PhD, Aristoteles Giagounidis, Uwe Platzbecker, MD, Alan F List, MD, Jianhua Zhong, PhD, Chengqing Wu, PhD, Konstantinos Mavrommatis, C.L. Beach, PharmD, Albert Hoenekopp, MD, Kyle J. MacBeth, PhD

Blood (2016) 128 (22): 225.

https://doi.org/10.1182/blood.V128.22.225.225

Published: 2016

Journal Articles

Safety of Lenalidomide (LEN) 10mg in Non-Del(5q) Versus Del(5q) in the Treatment of Patients (Pts) with Lower-Risk Myelodysplastic Syndromes (MDS): Pooled Analysis of Treatment-Emergent Adverse Events (TEAEs)

Antonio Almeida, MD PhD, Valeria Santini, MD, Stefanie Gröpper, MD, Anna Jonasova, MD, Norbert Vey, Aristoteles Giagounidis, MD PhD, Eva Hellström-Lindberg, MD PhD, Ghulam J. Mufti, MD PhD, Guillermo Sanz, MD PhD, Barry Skikne, MD, Albert Hoenekopp, MD, Francis Séguy, Jianhua Zhong, PhD, Pierre Fenaux, MD PhD

Blood (2015) 126 (23): 2880.

https://doi.org/10.1182/blood.V126.23.2880.2880

Published: 2015

Journal Articles

Efficacy and Safety of Lenalidomide (LEN) Versus Placebo (PBO) in RBC-Transfusion Dependent (TD) Patients (Pts) with IPSS Low/Intermediate (Int-1)-Risk Myelodysplastic Syndromes (MDS) without Del(5q) and Unresponsive or Refractory to Erythropoiesis-Stimulating Agents (ESAs): Results from a Randomized Phase 3 Study (CC-5013-MDS-005)

Blood (2014) 124 (21): 409.

https://doi.org/10.1182/blood.V124.21.409.409

Published: 2014

Journal Articles

Outcome of Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Based On Early Molecular Response and Factors Associated with Early Response: 4-Year Follow-up Data From Enestnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials Newly Diagnosed Patients)

Andreas Hochhaus, MD, Timothy P. Hughes, MD, MBBS, Giuseppe Saglio, François Guilhot, Haifa Kathrin Al-Ali, MD, Giantonio Rosti, Chiaki Nakaseko, MD, PhD, Carmino Antonio De Souza, PhD, Charisse Kemp, Xiaolin Fan, PhD, Albert Hoenekopp, MD, Richard A. Larson, MD, Hagop M. Kantarjian, MD

Blood (2012) 120 (21): 167.

https://doi.org/10.1182/blood.V120.21.167.167

Published: 2012

Journal Articles

The Incidence of BCR-ABL Mutations and Their Impact on Outcome in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Treated with Nilotinib or Imatinib in ENESTnd: 36-Month Follow-up

Timothy P. Hughes, MD, MBBS, Dong-Wook Kim, MD, PhD, Gabriel Etienne, MD, PhD, Carmino De Souza, MD, PhD, Mineo Kurokawa, MD, Matt Kalaycio, MD, Giuseppe Saglio, MD, Richard A. Larson, MD, Hagop M. Kantarjian, Albert Hoenekopp, MD, Yaping Shou, MD, PhD, Richard Yu, Rick E. Blakesley, PhD, Gianantonio Rosti, MD, Andreas Hochhaus, MD

Blood (2011) 118 (21): 2755.

https://doi.org/10.1182/blood.V118.21.2755.2755

Published: 2011

Journal Articles

Nilotinib Shows Safety and Efficacy in Older Patients (≥ 65 years) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase Comparable with That in Younger Patients with Chronic Myeloid Leukemia in Chronic Phase: Results From ENESTnd,

Richard A. Larson, MD, Udomsak Bunworasate, MD, Anna G. Turkina, MD, PhD, Stuart L. Goldberg, MD, Pedro Dorlhiac-Llacer, MD, Jose L. Lopez, MD, Hagop M. Kantarjian, Giuseppe Saglio, MD, Andreas Hochhaus, MD, Albert Hoenekopp, MD, Rick E. Blakesley, PhD, Richard Yu, Neil J. Gallagher, MD, PhD, Richard E. Clark, MD, Timothy P. Hughes, MD, MBBS

Blood (2011) 118 (21): 3768.

https://doi.org/10.1182/blood.V118.21.3768.3768

Published: 2011

Journal Articles

Results From the ENESTnd Extension Study: Efficacy and Safety of Patients (pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP), Treated with Nilotinib 400 Mg Twice Daily (BID) After Suboptimal Response (SoR) or Treatment Failure (TF) to Imatinib 400 Mg Once Daily (QD) or Nilotinib 300 Mg BID

Andreas Hochhaus, MD, Gert Ossenkoppele, MD, PhD, Josy Reiffers, MD, Ming Yao, MD, Hirohiko Shibayama, MD, PhD, Norbert Gattermann, MD, Timothy P. Hughes, MD, MBBS, Giuseppe Saglio, MD, Richard A. Larson, MD, Albert Hoenekopp, MD, Neil J. Gallagher, MD, PhD, Richard Yu, Rick E. Blakesley, PhD, Clarisse Lobo, MD, Hagop M. Kantarjian

Blood (2011) 118 (21): 114.

https://doi.org/10.1182/blood.V118.21.114.114

Published: 2011

Journal Articles

Nilotinib Versus Imatinib in Patients (pts) with Newly Diagnosed Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd 36-Month (mo) Follow-up

Giuseppe Saglio, MD, Philipp D. LeCoutre, MD, Ricardo Pasquini, MD, Saengsuree Jootar, Hirohisa Nakamae, MD, PhD, Ian W. Flinn, MD, PhD, Andreas Hochhaus, MD, Timothy P. Hughes, MD, MBBS, Richard A. Larson, MD, Albert Hoenekopp, MD, Neil J. Gallagher, MD, PhD, Richard Yu, Rick E. Blakesley, PhD, Dong-Wook Kim, Hagop M. Kantarjian

Blood (2011) 118 (21): 452.

https://doi.org/10.1182/blood.V118.21.452.452

Published: 2011

Journal Articles

ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP)

Timothy P. Hughes, MD, MBBS, Andreas Hochhaus, MD, Giuseppe Saglio, Dong-Wook Kim, MD, PhD, Saengsuree Jootar, MD, Philipp D. le Coutre, MD, Josy Reiffers, Ricardo Pasquini, MD, Clarisse Lobo, MD, Richard E. Clark, MD, Neil J. Gallagher, MD, PhD, Albert Hoenekopp, MD, Ariful Haque, Richard A. Larson, MD, Hagop M. Kantarjian, MD

Blood (2010) 116 (21): 207.

https://doi.org/10.1182/blood.V116.21.207.207

Published: 2010

Journal Articles

Cardiac Safety Profile of Imatinib and Nilotinib In Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP): Results From ENESTnd

Richard A. Larson, MD, Andreas Hochhaus, MD, Giuseppe Saglio, MD, PhD, Gianantonio Rosti, MD, Jose L. Lopez, MD, Leif Stenke, MD, PhD, Hirohisa Nakamae, M.D., Ph.D., Stuart L. Goldberg, M.D., Ming-Chung Wang, MD, Neil J. Gallagher, MD, PhD, Albert Hoenekopp, MD, Christine-Elke Ortmann, Timothy P. Hughes, MD, MBBS, Hagop M. Kantarjian, MD

Blood (2010) 116 (21): 2291.

https://doi.org/10.1182/blood.V116.21.2291.2291

Published: 2010

Journal Articles

Nilotinib Demonstrates Superior Efficacy Compared with Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: Results From the International Randomized Phase III ENESTnd Trial

Giuseppe Saglio, Dong-Wook Kim, MD, PhD, Surapol Issaragrisil, MD, FRCP, FACP, FRCPA, FRCPath, Philipp D. le Coutre, MD, Josy Reiffers, MD, Clarisse Lobo, MD, Ricardo Pasquini, MD, Richard E. Clark, MD, Timothy P. Hughes, MD, MBBS, Andreas Hochhaus, MD, Neil J. Gallagher, MD, PhD, Albert Hoenekopp, MD, Mei Dong, MD, MS, Ariful Haque, MS, Hagop M. Kantarjian, MD, Richard A. Larson, MD

Blood (2009) 114 (22): LBA-1.

https://doi.org/10.1182/blood.V114.22.LBA-1.LBA-1

Published: 2009

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Estimand Framework in AML Based on a Randomized, Placebo-Controlled, Phase 3 Study Investigating the Effect of Adding Midostaurin to Standard Chemotherapy in Patients with Newly Diagnosed AML without a FLT3 Mutation

Impact of Somatic Gene Mutations on Response to Lenalidomide (LEN) in IPSS Lower-Risk Myelodysplastic Syndromes (MDS) Patients (Pts) without Del(5q) and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents (ESAs)

Safety of Lenalidomide (LEN) 10mg in Non-Del(5q) Versus Del(5q) in the Treatment of Patients (Pts) with Lower-Risk Myelodysplastic Syndromes (MDS): Pooled Analysis of Treatment-Emergent Adverse Events (TEAEs)

Outcome of Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Based On Early Molecular Response and Factors Associated with Early Response: 4-Year Follow-up Data From Enestnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials Newly Diagnosed Patients)

The Incidence of BCR-ABL Mutations and Their Impact on Outcome in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Treated with Nilotinib or Imatinib in ENESTnd: 36-Month Follow-up

Nilotinib Shows Safety and Efficacy in Older Patients (≥ 65 years) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase Comparable with That in Younger Patients with Chronic Myeloid Leukemia in Chronic Phase: Results From ENESTnd,

Nilotinib Versus Imatinib in Patients (pts) with Newly Diagnosed Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd 36-Month (mo) Follow-up

ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP)

Cardiac Safety Profile of Imatinib and Nilotinib In Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP): Results From ENESTnd

Nilotinib Demonstrates Superior Efficacy Compared with Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: Results From the International Randomized Phase III ENESTnd Trial

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