Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy

Justin Loke; Marlen Metzner; Rebecca Boucher; Aimee Jackson; Louise Hopkins; Jiri Pavlu; Eleni Tholouli; Mark Drummond; Andy Peniket; Rebecca Bishop; Sonia Fox; Paresh Vyas; Charles Craddock

doi:10.1111/bjh.17823

Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy

Justin Loke, Marlen Metzner, Rebecca Boucher, Aimee Jackson, Louise Hopkins, Jiri Pavlu, Eleni Tholouli, Mark Drummond, Andy Peniket, Rebecca Bishop, Sonia Fox, Paresh Vyas, Charles Craddock

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Abstract

Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next-generation sequencing studies demonstrated important insights into therapy resistance.

Original language	English
Journal	British Journal of Haematology
Early online date	6 Sept 2021
DOIs	https://doi.org/10.1111/bjh.17823
Publication status	E-pub ahead of print - 6 Sept 2021

Bibliographical note

Keywords

acute myeloid leukaemia
clinical trial
early phase
hypomethylating agent
refractory
relapsed

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Loke, J., Metzner, M., Boucher, R., Jackson, A., Hopkins, L., Pavlu, J., Tholouli, E., Drummond, M., Peniket, A., Bishop, R., Fox, S., Vyas, P., & Craddock, C. (2021). Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy. British Journal of Haematology. Advance online publication. https://doi.org/10.1111/bjh.17823

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title = "Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy",

abstract = "Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next-generation sequencing studies demonstrated important insights into therapy resistance.",

keywords = "acute myeloid leukaemia, clinical trial, early phase, hypomethylating agent, refractory, relapsed",

author = "Justin Loke and Marlen Metzner and Rebecca Boucher and Aimee Jackson and Louise Hopkins and Jiri Pavlu and Eleni Tholouli and Mark Drummond and Andy Peniket and Rebecca Bishop and Sonia Fox and Paresh Vyas and Charles Craddock",

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Loke, J, Metzner, M, Boucher, R , Jackson, A, Hopkins, L, Pavlu, J, Tholouli, E, Drummond, M, Peniket, A, Bishop, R, Fox, S, Vyas, P & Craddock, C 2021, 'Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy', British Journal of Haematology. https://doi.org/10.1111/bjh.17823

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T1 - Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy

AU - Loke, Justin

AU - Metzner, Marlen

AU - Boucher, Rebecca

AU - Jackson, Aimee

AU - Hopkins, Louise

AU - Pavlu, Jiri

AU - Tholouli, Eleni

AU - Drummond, Mark

AU - Peniket, Andy

AU - Bishop, Rebecca

AU - Fox, Sonia

AU - Vyas, Paresh

AU - Craddock, Charles

PY - 2021/9/6

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N2 - Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next-generation sequencing studies demonstrated important insights into therapy resistance.

AB - Azacitidine (AZA) is important in the management of patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Romidepsin (ROM) is a histone deacetylase inhibitor which synergises with AZA in vitro. The ROMAZA trial established the maximum tolerated dose (MTD) of combined ROM/AZA therapy in patients with AML, as ROM 12 mg/m2 on Days 8 and 15, with AZA 75 mg/m2 administered for 7/28 day cycle. Nine of the 38 (23·7%) patients treated at the MTD were classified as responders by Cycle 6 (best response: complete remission [CR]/incomplete CR n = 7, partial response n = 2). Correlative next-generation sequencing studies demonstrated important insights into therapy resistance.

KW - acute myeloid leukaemia

KW - clinical trial

KW - early phase

KW - hypomethylating agent

KW - refractory

KW - relapsed

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SN - 0007-1048

JO - British Journal of Haematology

JF - British Journal of Haematology

ER -

Combination romidepsin and azacitidine therapy is well tolerated and clinically active in adults with high-risk acute myeloid leukaemia ineligible for intensive chemotherapy

Abstract

Bibliographical note

Keywords

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