Clinical trials: IDH1 Mutation
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
Recurrent Low Grade Astrocytoma, Recurrent WHO Grade 2 Glioma
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with…
- Conditions
- Recurrent Low Grade Astrocytoma, Recurrent WHO Grade 2 Glioma, Refractory Low Grade Astrocytoma, Refractory Low Grade Glioma
- Trial name
- NCT04576117
- Testing
- Biospecimen Collection, Magnetic Resonance Imaging, Quality-of-Life Assessment
- Where
- 101 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- National Cancer Institute (NCI)
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)
Acute Myeloid Leukemia, Relapsed Adult AML
Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.
- Conditions
- Acute Myeloid Leukemia, Relapsed Adult AML, Relapsed Pediatric AML
- Trial name
- NCT03245424
- Testing
- ivosidenib (AG-120)
- Sponsor
- Agios Pharmaceuticals, 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
Glioma, Recurrence
Vorasidenib Expanded Access Program
This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
- Conditions
- Glioma, Recurrence, Disease Attributes, Pathologic Processes
- Trial name
- NCT05592743
- Testing
- Vorasidenib
- Sponsor
- Servier
AML, IDH1 Mutation
Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML
Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission…
- Conditions
- AML, IDH1 Mutation, Treatment
- Trial name
- IDH1-AML-2024 (NCT06611839)
- Testing
- Ivosidenib, Venetoclax, Azacitidine
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or…
- Trial name
- NCT07286292
- Testing
- Vorasidenib
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
High Grade Glioma, Astrocytoma
Study of Olutasidenib and Temozolomide in HGG
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
- Conditions
- High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV
- Trial name
- NCT06161974
- Testing
- Olutasidenib + TMZ
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 60 people
- Sponsor
- Rigel Pharmaceuticals
AML
The Mutation Profile and Prognosis in AML With IDH1/2 Mutation
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients.
- Trial name
- NCT07004816
- Testing
- Uncover mutation profiles
- Where
- China
- Volunteers
- 1,015 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Residual or Recurrent Grade 2 IDH Mutant Glioma
Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation
The objective of this study is to determine the efficacy, safety, and pharmacokinetics of vorasidenib in Asian participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation.
- Trial name
- NCT06780930
- Testing
- Vorasidenib
- Where
- 8 sites in China, Taiwan
- Volunteers
- 57 people
- Sponsor
- Servier
Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme
Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:
A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q.
- Conditions
- Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme, Glioma of Brainstem, Glioma, Diffuse Midline, H3K27M-mutant
- Trial name
- NCT07608003
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xiangya Hospital of Central South University
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
Recurrent Ependymoma, Recurrent Ewing Sarcoma
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or…
- Conditions
- Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis
- Trial name
- NCT04195555
- Testing
- Ivosidenib
- Where
- 174 sites in United States, Australia and 1 more
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
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