AG-221

DRUG8 trials

Conditions

AML Arising After Exposure to Genotoxic InjuryAML Arising From Antecedent Hematologic Disorder (AHD)AML Arising From Myelodysplastic Syndrome (MDS)Acute Myeloid LeukemiaHealthyHealthy VolunteersIsocitrate DehydrogenaseLeukemia Acute Myeloid

Phase 1

PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects

CompletedNCT02387866

CelgeneHealthy

Start: 2015-03-02End: 2015-07-27Updated: 2018-10-30

Radiolabeled Study of AG-221 in Healthy Male Subjects.

CompletedNCT02443168

CelgeneHealthy Volunteers

Start: 2015-05-14End: 2015-07-21Updated: 2018-10-30

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Active, not recruitingNCT02632708

Institut de Recherches Internationales ServierAML Arising After Exposure to Genotoxic Injury, AML Arising From Antecedent Hematologic Disorder (AHD), AML Arising From Myelodysplastic Syndrome (MDS) +2

Start: 2015-12-31End: 2026-07-24Updated: 2025-04-11

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Active, not recruitingNCT02677922

CelgeneLeukemia, Myeloid, Acute

Start: 2016-06-03End: 2026-09-30Updated: 2026-02-19

Phase 2

IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

Active, not recruitingNCT03744390

Groupe Francophone des MyelodysplasiesLeukemia Acute Myeloid, Myelodysplastic Syndromes

Start: 2019-04-02End: 2026-03-18Target: 68Updated: 2025-05-18

Phase 3

An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

CompletedNCT02577406

CelgeneIsocitrate Dehydrogenase, Leukemia, Myeloid

Start: 2015-12-30End: 2024-03-25Updated: 2025-05-18

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Active, not recruitingNCT03839771

Stichting Hemato-Oncologie voor Volwassenen NederlandAcute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2

Start: 2019-03-01End: 2034-09-19Target: 968Updated: 2024-10-02

Unknown Phase

Expanded Access for AG-221

NCT03723057

CelgeneAcute Myeloid Leukemia

Updated: 2019-10-24

Blood2025-11-03

Enasidenib (ENA) Monotherapy in Patients with IDH2 mutated Myelodysplastic Syndrome (MDS), the Ideal Phase 2 Study By the GFM and Emsco Groups

Blood2024-11-055 citations

Somatic gene mutation patterns and burden influence outcomes with enasidenib in relapsed/refractory IDH2-mutated AML

Leukemia Research2024-03-27

Differentiation syndrome associated with treatment with IDH2 inhibitor enasidenib: pooled analysis from clinical trials

Blood Advances2024-03-2011 citations

Deconvoluting Clonal and Cellular Architecture in IDH-Mutant Acute Myeloid Leukemia

Blood2023-11-02

Molecular Features Associated with Response to Enasidenib Plus Azacitidine in Newly Diagnosed IDH2-Mutated Acute Myeloid Leukemia

Journal of Clinical Haematology2023-08-281 citations

AML: Therapie älterer Patient*innen mit rezidivierter oder refraktärer Erkrankung bleibt schwierig

Kompass Onkologie2023-01-01

Molecular Features Associated with Response to Combination Therapy with Enasidenib (ENA) Plus Azacitidine (AZA) in Newly Diagnosed IDH2-Mutated Acute Myeloid Leukemia (AML)

Blood2022-11-15

Enasidenib vs conventional care in older patients with late-stage mutant-IDH2 relapsed/refractory AML: a randomized phase 3 trial

Blood2022-06-17103 citations

Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY trial.

Journal of Clinical Oncology2022-06-014 citations

Pharmacokinetic/Pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined With Intensive Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed IDH1/2‐Mutant Acute Myeloid Leukemia

Clinical Pharmacology in Drug Development2022-02-149 citations

Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations

Clinical Cancer Research2022-01-18154 citations

Enasidenib (ENA) Is Effective in Patients with IDH2 Mutated Myelodysplastic Syndrome (MDS) : The Ideal Phase 2 Study By the GFM Group

Blood2021-11-0522 citations

AGILE: A Global, Randomized, Double-Blind, Phase 3 Study of Ivosidenib + Azacitidine Versus Placebo + Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation

Blood2021-11-0512 citations

Updated Survival and Response Analyses from a Phase 1 Study of Ivosidenib or Enasidenib Combined with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed AML with an IDH1 or IDH2 Mutation

Blood2021-11-053 citations

Blood2021-11-051 citations

Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial.

2021-10-18139 citations

Targeting IDH1 and IDH2 Mutations in Acute Myeloid Leukemia: Emerging Options and Pending Questions

HemaSphere2021-06-0112 citations

Molecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine

Blood2020-11-041 citations

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