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Last Updated: October 7, 2024

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CLINICAL TRIALS PROFILE FOR IDHIFA


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All Clinical Trials for Idhifa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01915498 ↗ Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation Active, not recruiting Agios Pharmaceuticals, Inc. Phase 1/Phase 2 2013-09-20 The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: - To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. - To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies. The primary objective of Phase 2 is: • To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
NCT01915498 ↗ Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation Active, not recruiting Celgene Phase 1/Phase 2 2013-09-20 The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: - To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. - To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies. The primary objective of Phase 2 is: • To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
NCT01915498 ↗ Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation Active, not recruiting Celgene Corporation Phase 1/Phase 2 2013-09-20 The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: - To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies. - To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies. The primary objective of Phase 2 is: • To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
NCT03515512 ↗ IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation Active, not recruiting Celgene Phase 1 2018-07-17 This research study is studying a targeted therapy drug as a possible treatment for IDH2 mutant acute myeloid leukemia or chronic myelomonocytic leukemia while undergoing hematopoietic stem cell transplantation. The drug involved in this study is: -Enasidenib.
NCT03515512 ↗ IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation Active, not recruiting Massachusetts General Hospital Phase 1 2018-07-17 This research study is studying a targeted therapy drug as a possible treatment for IDH2 mutant acute myeloid leukemia or chronic myelomonocytic leukemia while undergoing hematopoietic stem cell transplantation. The drug involved in this study is: -Enasidenib.
NCT03683433 ↗ Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation Unknown status National Cancer Institute (NCI) Phase 2 2018-09-18 This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT03683433 ↗ Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation Unknown status M.D. Anderson Cancer Center Phase 2 2018-09-18 This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Idhifa

Condition Name

Condition Name for Idhifa
Intervention Trials
IDH2 Gene Mutation 5
Recurrent Acute Myeloid Leukemia 5
Acute Myeloid Leukemia 4
Refractory Acute Myeloid Leukemia 3
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Condition MeSH

Condition MeSH for Idhifa
Intervention Trials
Leukemia, Myeloid, Acute 8
Leukemia, Myeloid 8
Leukemia 8
Neoplasms 3
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Clinical Trial Locations for Idhifa

Trials by Country

Trials by Country for Idhifa
Location Trials
United States 49
Canada 3
France 1
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Trials by US State

Trials by US State for Idhifa
Location Trials
California 6
Tennessee 4
Florida 4
Texas 3
Ohio 3
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Clinical Trial Progress for Idhifa

Clinical Trial Phase

Clinical Trial Phase for Idhifa
Clinical Trial Phase Trials
Phase 2 3
Phase 1/Phase 2 2
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for Idhifa
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for Idhifa

Sponsor Name

Sponsor Name for Idhifa
Sponsor Trials
National Cancer Institute (NCI) 6
Celgene 4
City of Hope Medical Center 3
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Sponsor Type

Sponsor Type for Idhifa
Sponsor Trials
Industry 9
Other 9
NIH 6
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