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Devimistat in combination with high dose cytarabine and mitoxantrone compared with high dose cytarabine and mitoxantrone in older patients with relapsed/refractory acute myeloid leukemia: ARMADA 2000 Phase III study.
Pardee, Timothy S; Luther, Sanjeev; Buyse, Marc; Powell, Bayard L; Cortes, Jorge.
Afiliação
  • Pardee TS; Wake Forest Baptist Comprehensive Cancer Center, Department of Internal Medicine, Section on Hematology & Oncology, Winston-Salem, NC 27101, USA.
  • Luther S; Rafael Pharmaceuticals, Cranbury, NJ 08512, USA.
  • Buyse M; Rafael Pharmaceuticals, Cranbury, NJ 08512, USA.
  • Powell BL; International Drug Development Institute, Louvain-La-Neuve, Belgium.
  • Cortes J; Wake Forest Baptist Comprehensive Cancer Center, Department of Internal Medicine, Section on Hematology & Oncology, Winston-Salem, NC 27101, USA.
Future Oncol ; 15(28): 3197-3208, 2019 Oct.
Article em En | MEDLINE | ID: mdl-31512500
Devimistat (CPI-613®) is an intravenously administered, novel lipoate analog that inhibits two key tricarboxcylic acid (TCA) cycle enzymes, pyruvate dehydrogenase (PDH) and α-ketoglutarate dehydrogenase complexes (KGDH). These complexes control TCA cycle entry of glucose and glutamine-derived carbons, respectively. Acute myeloid leukemia (AML) cells upregulate the TCA cycle in response to DNA damaging agents and treatment with devimistat increases sensitivity to them. A Phase I study of devimistat in combination with cytarabine and mitoxantrone produced a complete remission rate of 50% in patients with relapsed or refractory AML. In the combined Phase I/II experience, older patients with R/R AML treated with 2000 mg/m2 of devimistat had a 52% complete remission/complete remission with incomplete hematologic recovery rate and a median survival of 12.4 months. This report outlines the rationale and design of the ARMADA 2000 study, a Phase III clinical trial of devimistat in combination with high dose cytarabine and mitoxantrone compared with high dose cytarabine and mitoxantrone alone for older patients (≥60 years of age) with relapsed or refractory AML. Clinical trial registration: NCT#03504410.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia de Salvação / Resistencia a Medicamentos Antineoplásicos / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia de Salvação / Resistencia a Medicamentos Antineoplásicos / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article