Clinical trials: IDH2 Gene Mutation
Hematologic Neoplasms
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
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…
- Trial name
- NCT01915498
- Testing
- Enasidenib
- Where
- 24 sites in United States, France
- Volunteers
- 345 people
- Sponsor
- Celgene
Recurrent Acute Myeloid Leukemia
CPX-351 Plus Enasidenib for Relapsed AML
This trial evaluates how well CPX-351 and enasidenib work in treating patients with acute myeloid leukemia characterized by IHD2 mutation.
- Trial name
- NCT03825796
- Testing
- Enasidenib Mesylate, Liposome-encapsulated Daunorubicin-Cytarabine
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Acute Myeloid Leukemia, NPM1 Mutation
Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations
This prospective, multicenter, randomized, open-label, non-inferiority clinical study aims to compare the efficacy and safety of VA regimen (venetoclax combined with azacitidine) versus conventional "3+7" chemotherapy regimen in…
- Conditions
- Acute Myeloid Leukemia, NPM1 Mutation, IDH1 Mutation, IDH2 Mutation
- Trial name
- NCT07664839
- Testing
- VEN combined with azacitidine, Cytarabine plus Daunorubicin
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Shen yang
Leukemia, Myeloid, Isocitrate Dehydrogenase
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
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML)…
- Trial name
- IDHENTIFY (NCT02577406)
- Testing
- AG-221, BSC, Azacitidine
- Where
- 93 sites in United States, Australia and 16 more
- Volunteers
- 319 people
- Sponsor
- Celgene
Acute Myeloid Leukemia
Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
This phase II trial studies the side effects of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant.
- Trial name
- NCT03728335
- Testing
- Enasidenib Mesylate
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- City of Hope Medical Center
IDH1-mutant Glioma, IDH2-mutant Glioma
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib.
- Trial name
- NCT06478212
- Testing
- Vorasidenib, Temozolomide (TMZ)
- Where
- 28 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- Institut de Recherches Internationales Servier
Glioblastoma, IDH1 Gene Mutation
BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas
This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma that is newly diagnosed or has come back.
- Conditions
- Glioblastoma, IDH1 Gene Mutation, IDH2 Gene Mutation, Low Grade Glioma
- Trial name
- PNOC017 (NCT03749187)
- Testing
- PARP Inhibitor BGB-290, Temozolomide (TMZ)
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of California, San Francisco
Grade 2 Glioma, Residual Glioma
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2…
- Conditions
- Grade 2 Glioma, Residual Glioma, Recurrent Glioma
- Trial name
- NCT04164901
- Testing
- Vorasidenib
- Where
- 84 sites in United States, Canada and 9 more
- Volunteers
- 331 people
- Sponsor
- Institut de Recherches Internationales Servier
Low-grade Glioma, IDH2 Gene Mutation
Niraparib In Recurrent IDH 1/2 Gliomas
This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma.
- Conditions
- Low-grade Glioma, IDH2 Gene Mutation, Recurrent Glioma, IDH1 Mutation
- Trial name
- NCT05406700
- Testing
- Niraparib, Resection/Treatment with Niraparib
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Acute Myeloid Leukemia
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.
- Trial name
- NCT04272957
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Hutchison Medipharma Limited
Blasts Under 5 Percent of Peripheral Blood White Cells, Bone Marrow Blasts Decreased by 50 Percent or More Compared to Pretreatment Level
Enasidenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH2 Gene Mutation
This phase II trial studies how well enasidenib works in treating in patients with acute myeloid leukemia with an IDH2 gene mutation that has come back or has not responded to treatment.
- 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
- Trial name
- NCT03881735
- Testing
- Enasidenib, Hematopoietic Cell Transplantation
- Where
- 2 sites in United States
- Sponsor
- Roswell Park Cancer Institute
Solid Tumor, Glioma
Study of Orally Administered Enasidenib (AG-221) in Adults With Advanced Solid Tumors, Including Glioma, or Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation
The purpose of this study is to evaluate the safety, pharmacokinetics, and clinical activity of enasidenib in adults with advanced solid tumors, including glioma, or with angioimmunoblastic T-cell lymphoma (AITL), with an…
- Conditions
- Solid Tumor, Glioma, Angioimmunoblastic T-cell Lymphoma, Intrahepatic Cholangiocarcinoma
- Trial name
- NCT02273739
- Testing
- Enasidenib
- Where
- 12 sites in United States, France
- Volunteers
- 21 people
- Sponsor
- Celgene
Brain Tumor, Recurrent, Malignant Glioma (WHO Grade III or IV)
Chronic CED of TPT for Recurrent Malignant Glioma
The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase…
- Conditions
- Brain Tumor, Recurrent, Malignant Glioma (WHO Grade III or IV), IDH1/IDH2 Mutation
- Trial name
- TPT CED rHGG (NCT06666712)
- Testing
- Topotecan
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Jeffrey N. Bruce
Acute Myelogenous Leukemia
A Phase 1 Study of SH1573 Capsules in Subjects With Refractory or Relapsed Acute Myelogenous Leukemia
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of SH1573 in subjects with advanced relapsed, refractory acute myelogenous leukemia that harbor an IDH2 mutation.
- Trial name
- NCT04806659
- Testing
- SH1573 Capsules
- Where
- 2 sites in China
- Volunteers
- 41 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, Hematologic Malignancies
- Trial name
- NCT02492737
- Testing
- AG881
- Where
- 6 sites in United States, France
- Volunteers
- 46 people
- Sponsor
- Agios Pharmaceuticals, Inc.
Advanced Solid Tumor, NSCLC (Non-small Cell Lung Cancer)
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are…
- Conditions
- Advanced Solid Tumor, NSCLC (Non-small Cell Lung Cancer), Renal Cancer, Mesothelioma
- Trial name
- NCT05873686
- Testing
- NXP900
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 140 people
- Sponsor
- Nuvectis Pharma, Inc.
Chondrosarcomas, Cartilage Tumours
Diagnostic and Therapeutic Targets in Cartilaginous Tumours
This study, "Finding new diagnostic and therapeutic targets in cartilaginous tumours," focuses on improving the diagnosis, prognostic stratification, and treatment options for chondroid tumours, particularly chondrosarcoma.
- Trial name
- NCT07315542
- Testing
- Tumour tissue analysis, Molecular validation, Liquid biopsy analysis
- Where
- Czechia
- Volunteers
- 300 people
- Sponsor
- St. Anne's University Hospital Brno, Czech Republic
Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis
Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation
The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia.
- Conditions
- Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis, IDH2 Mutation
- Trial name
- NCT04281498
- Testing
- Ruxolitinib, Enasidenib
- Where
- 11 sites in United States, Canada
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- John Mascarenhas
Leukemia, Myeloid, Acute
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
The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2.
- Trial name
- NCT02677922
- Testing
- AG-120, Azacitidine, AG-221
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 130 people
- Sponsor
- Celgene
Brain Tumor, Cancer
000860: A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Protocol # 000860 Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed.
- Trial name
- NCT05588141
- Testing
- Zotiraciclib
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- National Cancer Institute (NCI)