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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: AG-221 Clear all
Active, not recruiting Phase 1Phase 2 Interventional Results available

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

NCT02677922
View directory record Official record
Conditions
Leukemia, Myeloid, Acute
Interventions
AG-120, Azacitidine, AG-221
Drug
Lead sponsor
Celgene
Industry
Eligibility
18 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2026
U.S. locations
9
States / cities
Duarte, California • New Haven, Connecticut • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 18, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 2 Interventional

Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

NCT03683433
View directory record Official record
Conditions
Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Azacitidine, Enasidenib Mesylate
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 4, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

NCT04573582
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Enasidenib
Drug
Lead sponsor
Celgene
Industry
Eligibility
40 Years to 75 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
3
States / cities
Miami, Florida • Orlando, Florida • Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jul 14, 2024 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional

Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

NCT05441514
View directory record Official record
Conditions
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Cobimetinib, Enasidenib Mesylate
Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated May 4, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 2 Interventional

IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

NCT05401097
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Azacitidine, Biopsy, Enasidenib, Ivosidenib, Venetoclax
Drug · Procedure
Lead sponsor
Alice Mims
Other
Eligibility
18 Years and older
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2029
U.S. locations
4
States / cities
Aurora, Colorado • Chapel Hill, North Carolina • Columbus, Ohio + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT02387866
View directory record Official record
Conditions
Healthy
Interventions
AG-221
Drug
Lead sponsor
Celgene
Industry
Eligibility
20 Years to 50 Years · Male only
Enrollment
62 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Oct 29, 2018 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

NCT04075747
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
CPX-351, Venetoclax, Midostaurin, Enasidenib
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
10
States / cities
Duarte, California • Palo Alto, California • Augusta, Georgia + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2023 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 1 Interventional

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

NCT05756777
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Gilteritinib, Ivosidenib, Enasidenib
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Active, not recruiting Phase 2 Interventional

CPX-351 Plus Enasidenib for Relapsed AML

NCT03825796
View directory record Official record
Conditions
Recurrent Acute Myeloid Leukemia
Interventions
Enasidenib Mesylate, Liposome-encapsulated Daunorubicin-Cytarabine
Drug
Lead sponsor
Jonsson Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
3
States / cities
Los Angeles, California • Sacramento, California • San Diego, California
Source: ClinicalTrials.gov public record
Updated Sep 27, 2023 · Synced Sep 5, 2026, 9:15 AM EDT
Withdrawn Phase 1 Interventional

A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

NCT04955938
View directory record Official record
Conditions
IDH Mutation, IDH1 Mutation, IDH2 Gene Mutation, Blood Cancer, Myeloproliferative Neoplasm
Interventions
Ivosidenib, Enasidenib, Fedratinib
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jul 30, 2024 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 2Phase 3 Interventional

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

NCT03013998
View directory record Official record
Conditions
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Interventions
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21 Group 1), ficlatuzumab (BAML-16-001-S24), Azacitidine (BAML-16-001-S24), Venetoclax (BAML-16-001-S24), ZE46-0134 (BAML-16-001-S21 Group 2), Bleximenib (BAML-16-001-S25/HO181), Cytarabine (BAML-16-001-S25/HO181), Daunorubicin or Idarubicin (BAML-16-001-S25/HO181), Placebo (BAML-16-001-S25/HO181), Revumenib (BAML-16-001-S26/HO177), Placebo (BAML-16-001-S26/HO177)
Biological · Other · Drug
Lead sponsor
Beat AML, LLC
Other
Eligibility
18 Years and older
Enrollment
3,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2032
U.S. locations
31
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Los Angeles, California + 26 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1Phase 2 Interventional

Myeloma-Developing Regimens Using Genomics (MyDRUG)

NCT03732703
View directory record Official record
Conditions
Relapsed Refractory Multiple Myeloma
Interventions
Abemaciclib, dexamethasone, ixazomib, pomalidomide, Enasidenib, dexamethasone, ixazomib, pomalidomide, Cobimetinib, dexamethasone, ixazomib, pomalidomide, Erdafitinib, dexamethasone, ixazomib, pomalidomide, Venetoclax, dexamethasone, ixazomib, pomalidomide, Daratumumab, dexamethasone, ixazomib, pomalidomide, Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Selinexor, dexamethasone, ixazomib, pomalidomide
Drug
Lead sponsor
Multiple Myeloma Research Consortium
Network
Eligibility
18 Years and older
Enrollment
103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
16
States / cities
Phoenix, Arizona • Duarte, California • Atlanta, Georgia + 10 more
Source: ClinicalTrials.gov public record
Updated Feb 13, 2025 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional

IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation

NCT03515512
View directory record Official record
Conditions
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Interventions
Enasidenib
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
4
States / cities
Baltimore, Maryland • Boston, Massachusetts • Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 13, 2025 · Synced Sep 5, 2026, 9:15 AM EDT
Active, not recruiting Phase 2 Interventional

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

NCT04203316
View directory record Official record
Conditions
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Enasidenib, Enasidenib Mesylate
Procedure · Drug
Lead sponsor
Children's Oncology Group
Network
Eligibility
24 Months to 21 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
27
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Aurora, Colorado + 23 more
Source: ClinicalTrials.gov public record
Updated Jan 8, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Withdrawn Phase 2 Interventional

Enasidenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH2 Gene Mutation

NCT03881735
View directory record Official record
Conditions
Blasts Under 5 Percent of Peripheral Blood White Cells, Bone Marrow Blasts Decreased by 50 Percent or More Compared to Pretreatment Level, IDH2 Gene Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Enasidenib, Hematopoietic Cell Transplantation
Drug · Procedure
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
2
States / cities
Buffalo, New York • East Hills, New York
Source: ClinicalTrials.gov public record
Updated Mar 9, 2021 · Synced Sep 5, 2026, 9:15 AM EDT
No Longer Available No phase listed Expanded access

Expanded Access for AG-221

NCT03723057
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
AG-221
Drug
Lead sponsor
Celgene
Industry
Eligibility
18 Years and older
U.S. locations
1
States / cities
Summit, New Jersey
Source: ClinicalTrials.gov public record
Updated Oct 23, 2019 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 2 Interventional

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

NCT06577441
View directory record Official record
Conditions
Myelodysplastic Syndrome
Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, Enasidenib
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
142
States / cities
Berkeley, California • Irvine, California • Orange, California + 118 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1 Interventional

A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.

NCT03290443
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Enasidenib
Drug
Lead sponsor
Celgene
Industry
Eligibility
40 Years to 65 Years
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
5
States / cities
Lakewood, Colorado • Miami, Florida • Orlando, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2020 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02577406
View directory record Official record
Conditions
Leukemia, Myeloid, Isocitrate Dehydrogenase
Interventions
AG-221, BSC, Azacitidine, Low-dose cytarabine (LDAC), Intermediate-dose cytarabine (IDAC)
Drug · Other
Lead sponsor
Celgene
Industry
Eligibility
60 Years and older
Enrollment
319 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2024
U.S. locations
12
States / cities
Miami, Florida • Orlando, Florida • Chicago, Illinois + 9 more
Source: ClinicalTrials.gov public record
Updated May 17, 2025 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 1Phase 2 Interventional

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

NCT04774393
View directory record Official record
Conditions
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Decitabine and Cedazuridine, Enasidenib, Ivosidenib, Venetoclax
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 19, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Recruiting Phase 2 Interventional

Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

NCT06240754
View directory record Official record
Conditions
Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
Interventions
Enasidenib
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

NCT05282459
View directory record Official record
Conditions
Leukemia, Leukemia, Myeloid, Monocytic Leukemia
Interventions
Enasidenib mesylat dose escalation
Drug
Lead sponsor
Tian Yi Zhang
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Enasidenib in People With T-Cell Lymphoma

NCT06756308
View directory record Official record
Conditions
T-cell Lymphoma
Interventions
Enasidenib, Rituximab
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 3 more
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 5, 2026, 9:15 AM EDT
Withdrawn Phase 1 Interventional

Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

NCT04655391
View directory record Official record
Conditions
Recurrent Acute Myeloid Leukemia
Interventions
Bosutinib Monohydrate, Decitabine, Enasidenib Mesylate, Gilteritinib Fumarate, Glasdegib Maleate, Ivosidenib, Venetoclax
Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Jun 8, 2022 · Synced Sep 5, 2026, 9:15 AM EDT