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|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|IDH2 R140X||myelodysplastic syndrome||predicted - sensitive||IDH2 Inhibitor||Enasidenib||Phase II||Actionable||In a Phase II trial, Idhifa (enasidenib) treatment was well tolerated and resulted in an overall response rate of 43% (9/21, 5 complete remission (CR), 1 partial remission, 1 marrow CR, 2 hematological improvement only) in patients with higher-risk myelodysplastic syndrome harboring IDH2 R140 or R172 mutations who were refractory to or progressed on hypomethylating agents, with a median overall survival of 21.3 months (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7010-7010; NCT03383575).||detail...|
|IDH2 R140X||myelodysplastic syndrome||predicted - sensitive||IDH2 Inhibitor||Azacitidine + Enasidenib||Phase II||Actionable||In a Phase II trial, Idhifa (enasidenib) and Vidaza (azacitidine) combination treatment was well tolerated and resulted in an overall response rate of 68% (30/46, 11 complete remission (CR), 3 partial remission, 12 marrow CR, 4 hematological improvement only) in patients with higher-risk myelodysplastic syndrome harboring IDH2 R140 or R172 mutations who were naive to hypomethylating agents, with a median overall survival of 21.3 months (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7010-7010; NCT03383575).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03515512||Phase I||Enasidenib||IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation||Active, not recruiting||USA||0|
|NCT03383575||Phase II||Azacitidine + Enasidenib Enasidenib||Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome||Active, not recruiting||USA||0|
|NCT04603001||Phase I||LY3410738||Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations||Recruiting||USA | CAN||9|
|NCT02677922||Phase Ib/II||Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib||A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)||Unknown status||USA | CAN||10|
|NCT03914742||Phase Ib/II||Pamiparib + Temozolomide||BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations||Recruiting||USA||0|
|NCT04092179||Phase Ib/II||Enasidenib + Venetoclax||Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers||Recruiting||CAN||0|
|NCT03839771||Phase III||Ivosidenib Enasidenib||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 (HOVON150AML)||Recruiting||15|
|NCT04522895||Phase II||Enasidenib||IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT||Recruiting||1|