Clinical trials: IDH1 Mutation
Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult…
- Conditions
- Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute
- Trial name
- AGILE (NCT03173248)
- Testing
- AG-120, Azacitidine
- Where
- 90 sites in United States, Australia and 18 more
- Volunteers
- 146 people
- Sponsor
- Institut de Recherches Internationales Servier
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
Myeloid Malignancies
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.
- Trial name
- NCT06668584
- Testing
- Olutasidenib
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
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
AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an…
- Trial name
- HOVON150AML (NCT03839771)
- Testing
- AG-120, AG-221
- Where
- 181 sites in Australia, Austria and 13 more
- Volunteers
- 968 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
Recurrent High-grade Glioma
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.
- Trial name
- NCT02333513
- Testing
- Lomustine/Vincristine/Procarbazine
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Hebei Yanda Hospital
AML, Adult
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.
- Trial name
- NCT02986620
- Testing
- IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
- Where
- 24 sites in Italy
- Volunteers
- 388 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
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
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Cholangiocarcinoma
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease.
- Trial name
- IDHIRA (NCT06607302)
- Where
- 19 sites in Germany
- Volunteers
- 100 people
- Sponsor
- iOMEDICO AG
Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation.
- Conditions
- Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT04493164
- Testing
- Ivosidenib, Liposome-encapsulated Daunorubicin-Cytarabine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Gliomas Harboring IDH1 and/or IDH2 Mutations
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1…
- Trial name
- NCT07025018
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Hutchmed
AML (Acute Myeloid Leukemia), Glioma
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.
- Conditions
- AML (Acute Myeloid Leukemia), Glioma, Cholangiocarcinoma, Solid Tumor Malignancies
- Trial name
- NCT07486713
- Testing
- Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Rigel Pharmaceuticals
Targeted Therapy, IDH1-Mutated Malignancies
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
To learn about the safety and tolerability of study drug combinations in patients with relapsed/refractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.
- Conditions
- Targeted Therapy, IDH1-Mutated Malignancies, Mutations
- Trial name
- NCT07032727
- Testing
- Olutasidenib, Cladribine (CLAD), Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Malignancies That Harbor IDHR132 Mutations
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
- Trial name
- NCT02381886
- Testing
- IDH305
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 166 people
- Sponsor
- Novartis Pharmaceuticals
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
Acute Myeloid Leukemia (AML)
IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients
This leukemia is characterized by a poor prognosis for most patients, as they have a high relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow transplantation.
- Trial name
- NCT03204838
- Testing
- IDH mutation test performed at diagnosis
- Where
- Mexico
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hospital General de Mexico
IDH1 Mutation, IDH2 Mutation
BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back.
- Conditions
- IDH1 Mutation, IDH2 Mutation, Recurrent Glioblastoma, Recurrent WHO Grade II Glioma
- Trial name
- NCT03914742
- Testing
- PARP Inhibitor BGB-290, Temozolomide, Therapeutic Conventional Surgery
- Where
- 12 sites in United States
- Volunteers
- 67 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Biliary Tract Cancer
Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC
Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1)…
- Trial name
- NCT07142226
- Testing
- Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- CHA University
Acute Myeloid Leukemia With Gene Mutations
Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients
The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who…
- Trial name
- DECISIVO (NCT07507760)
- Testing
- Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea
- Where
- 20 sites in Portugal, Spain
- Volunteers
- 50 people
- Sponsor
- PETHEMA Foundation
Glioma
Foci of Tumor Heterogeneity in Diffuse Low-Grade Gliomas
Background: Diffuse low-grade gliomas (DLGG) are slow-growing primary-cancer of the brain and spinal cord. They represent up to 15% of the developing tumors in those organs with fatal outcome for the patients because of their…
- Trial name
- FDLGG (NCT04423094)
- Where
- France
- Volunteers
- 8 people
- Sponsor
- University Hospital, Montpellier