Enasidenib

Generic Name: Enasidenib

Brand Names: Idhifa

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₇F_₆N_₇O

CAS Number: 1446502-11-9

Unique Ingredient Identifier: 3T1SS4E7AG

Background: Enasidenib is an orally available treatment for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with specific mutations in the isocitrate dehydrogenase 2 (IDH2) gene, which is a recurrent mutation detected in 12-20% of adult patients with AML . Patients eligible for this treatment are selected by testing the presence ...

Indication: Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

Associated Conditions: Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)

Associated Therapies: -

Clinical Trials

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

Phase 2

Not yet recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Decitabine and Cedazuridine
Drug: Venetoclax
Drug: Enasidenib

First Posted Date: 2024-11-04

Last Posted Date: 2024-11-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 93

Registration Number: NCT06672146

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)

Phase 2

Not yet recruiting

Conditions: Myelodysplastic Syndrome

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Decitabine and Cedazuridine
Drug: Enasidenib

First Posted Date: 2024-08-29

Last Posted Date: 2024-11-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 54

Registration Number: NCT06577441

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

Phase 2

Recruiting

Conditions: Clonal Cytopenia of Undetermined Significance
CCUS Clonal Cytopenia of Undetermined Significance

Interventions: Drug: Enasidenib

First Posted Date: 2024-02-05

Last Posted Date: 2024-10-15

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 15

Registration Number: NCT06240754

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

Phase 2

Recruiting

Conditions: Locally Advanced Chondrosarcoma
Locally Advanced Sinonasal Adenocarcinoma
Metastatic Olfactory Neuroblastoma
Locally Advanced Olfactory Neuroblastoma
Metastatic Sinonasal Undifferentiated Carcinoma
Metastatic Sinonasal Adenocarcinoma
Locally Advanced Large-cell Neuroendocrine Carcinoma
Metastatic Chondrosarcoma
Locally Advanced Sinonasal Undifferentiated Carcinoma
Metastatic Large-cell Neuroendocrine Carcinoma

Interventions: Drug: Enasidenib

First Posted Date: 2023-12-20

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT06176989

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Gilteritinib
Drug: Ivosidenib
Drug: Enasidenib

First Posted Date: 2023-03-06

Last Posted Date: 2024-11-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 36

Registration Number: NCT05756777

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 4 locations

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Drug: Azacitidine
Procedure: Mutation Carrier Screening
Other: Best Practice
Procedure: Bone Marrow Aspiration
Procedure: Biopsy
Drug: Decitabine and Cedazuridine
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Drug: Enasidenib
Drug: Gilteritinib
Drug: Daunorubicin Hydrochloride
Procedure: Echocardiography
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Drug: Venetoclax
Procedure: Multigated Acquisition Scan

First Posted Date: 2022-10-03

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2000

Registration Number: NCT05564390

Locations: 🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
🇺🇸
Marshfield Medical Center - Weston, Weston, Wisconsin, United States

and more 184 locations

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)

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Procedure: Biopsy
Drug: Enasidenib
Drug: Ivosidenib
Drug: Venetoclax

First Posted Date: 2022-06-02

Last Posted Date: 2024-03-04

Lead Sponsor: Alice Mims

Target Recruit Count: 125

Registration Number: NCT05401097

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Phase 1

Active, not recruiting

Conditions: Clonal Cytopenia of Undetermined Significance
CCUS Clonal Cytopenia of Undetermined Significance

Interventions: Drug: Enasidenib

First Posted Date: 2021-11-01

Last Posted Date: 2024-08-26

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 4

Registration Number: NCT05102370

Locations: 🇺🇸
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 9 locations