Clinical trials: IDH Mutation
Glioma, Malignant, IDH Mutation
Window of Opportunity Study of DSP-0390 in Gliomas
This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant glioma undergoing tumor resection. Tissue will be collected during surgical resection.
- Trial name
- NCT06636162
- Testing
- DSP-0390
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Grade II/III Glioma
CCRT With Temozolomide Versus RT Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy.
- Trial name
- NCT02766270
- Testing
- Temozolomide, Radiotherapy
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Tiantan Hospital
NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic
First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor
This is a phase 1, multicentre, first-in-human, open-label, dose-escalation/consolidation study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered JBI-778 in EGFR mutated…
- Conditions
- NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic, Adenoid Cystic Carcinoma of the Head and Neck
- Trial name
- NCT07755397
- Testing
- JBI-778
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Jubilant Therapeutics India Limited
Glioma, IDH Mutation
Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma
This study aims to look at how BAY 2402234 responds in body in patients with recurrent glioma.
- Trial name
- NCT05061251
- Testing
- BAY 2402234
- Sponsor
- University of Texas Southwestern Medical Center
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
Astrocytoma, Astrocytic Tumors
Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma
This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes.
- Conditions
- Astrocytoma, Astrocytic Tumors, Astrocytoma of Brain
- Trial name
- NCT06620926
- Testing
- IDH mutant-type, IDH wild-type
- Where
- Egypt
- Volunteers
- 811 people
- Sponsor
- asmaa salama ibrahim
Astrocytoma
Tuvusertib in Astrocytoma With ATRX Mutation
The TUVASTRAT study is a phase 2, non-randomized, two.cohort, CRS clinical trial of tuvusertib in patients with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma (Grade 2-4 from WHO classification).
- Trial name
- TUVASTRAT (NCT07417761)
- Testing
- Tuvusertib
- Where
- 10 sites in Spain
- Volunteers
- 56 people
- Sponsor
- Grupo Español de Investigación en Neurooncología
Glioma
Amino Acid PET to Assess the Efficacy of IDH Inhibitor Treatments for IDH Mutated Gliomas
Amino acid PET imaging could represent a biomarker for the evaluation of IDH inhibitor treatments for patients with refractory IDH-mutated gliomas
- Trial name
- TEP-IDH (NCT07017790)
- Testing
- Amino-acid PET
- Where
- France
- Volunteers
- 22 people
- Sponsor
- Central Hospital, Nancy, France
PCNSL, Brain Tumor
Neurocognitive Assessment CNSL and LGG
This study is to determine whether self-administered digital cognitive tests can serve as accurate and reliable alternatives to established neuropsychological tests for evaluating cognitive functioning in participants with…
- Conditions
- PCNSL, Brain Tumor, Cognitive Dysfunction, IDH Mutation
- Trial name
- NCT07710131
- Testing
- Digital Cognitive Assessment (TestMyBrain and Mobile Toolbox), Traditional Neuropsychological Testing, Quality of Life and Mood Questionnaires
- Volunteers
- 36 people
- Sponsor
- Dana-Farber 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
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine.
- Conditions
- Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02719574
- Testing
- FT-2102 (olutasidenib), Azacitidine, Cytarabine
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 336 people
- Sponsor
- Forma Therapeutics, Inc.
Acute Myeloid Leukemia
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)
This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH…
- Trial name
- NCT05401097
- Testing
- Azacitidine, Biopsy, Enasidenib
- Where
- 4 sites in United States
- Volunteers
- 125 people
- Sponsor
- Alice Mims
Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML
Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation
The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy.
- Conditions
- Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD)
- Trial name
- NCT02632708
- Testing
- AG-120, AG-221, cytarabine
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 153 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
Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4
IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas
STAR-VACC is a randomized double-blind controlled Phase 2 study assessing clinical efficacy of IDH1-vac in patients with newly diagnosed IDH1-mutant high-grade astrocytomas.
- Trial name
- STAR-VACC (NCT07888647)
- Testing
- IDH1-vac, IS-vac, Temozolomide (TMZ)
- Where
- 13 sites in Germany
- Volunteers
- 216 people
- Sponsor
- German Cancer Research Center
Adult Gliomas, Mixed
Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
- Trial name
- NCT05851378
- Testing
- Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG), Magnetic Resonance Image (MRI)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Robert Bok, MD, PhD
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
This phase II trial studies how well olaparib works in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or myelodysplastic syndrome.
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT03953898
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Olaparib
- Where
- 11 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Cancer Institute (NCI)
Glioma
Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas
Glioma is the most common primary intracranial tumor in adults, with high-grade gliomas accounting for more than 50% of all gliomas and having the highest mortality rate.
- Trial name
- NCT07405372
- Testing
- Targeted IDH PET/MRI
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Acute Myeloid Leukemia, IDH1 Gene Mutation
Prevalence and Clinical Effect of IDH1/2 Mutations in Patients With Acute Myeloid Leukemia
Among the most notable cancer genome-wide sequencing discoveries in recent years was the finding of mutation hot-spots in the isocitrate dehydrogenase (IDH) genes in grade II/III astrocytomas and oligodendrogliomas and in…
- Conditions
- Acute Myeloid Leukemia, IDH1 Gene Mutation, IDH2 Gene Mutation
- Trial name
- Euro_IDH_AML (NCT04369287)
- Where
- Italy
- Volunteers
- 654 people
- Sponsor
- Istituto Clinico Humanitas
Recurrent Glioma, IDH-mutant Gliomas
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
This phase I study will evaluate the safety and tolerability of vorasidenib in combination with lomustine and determine the recommended combination dose (RCD) of vorasidenib in adults with recurrent IDH1- or IDH2-mutant glioma.
- Trial name
- VALIENT (NCT07629089)
- Testing
- Vorasidenib, Lomustine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Megan Mantica