Clinical trials: IDH1 Mutation, open to volunteers
Biliary Tract Cancer
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea.
- Trial name
- NCT07151118
- Testing
- Blood Sampling for ctDNA Analysis
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- CHA University
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
- 2 sites in United States
- Volunteers
- 96 people
- Sponsor
- National Cancer Institute (NCI)
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
Acute Myeloid Leukemia, IDH1 Gene Mutation
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China…
- Conditions
- Acute Myeloid Leukemia, IDH1 Gene Mutation, Ivosidenib
- Trial name
- NCT07007949
- Testing
- Ivosidenib combined with venetoclax and azacitidine
- Where
- China
- Volunteers
- 42 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid…
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT06543381
- Testing
- Biospecimen Collection, Olutasidenib
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- City of Hope Medical Center
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
Acute Myeloid Leukemia, Hematopoietic and Lymphoid System Neoplasm
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies.
- Conditions
- Acute Myeloid Leukemia, Hematopoietic and Lymphoid System Neoplasm, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
- Trial name
- NCT03471260
- Testing
- Azacitidine, Ivosidenib, Venetoclax
- Where
- 4 sites in United States
- Volunteers
- 96 people
- Sponsor
- M.D. Anderson Cancer Center
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
AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS
This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker…
- Trial name
- NCT07607418
- Testing
- Ivosidenib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ruijin Hospital
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
Biliary Tract Cancer
An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.
This is a multicenter, non-randomized, umbrella, open-label phase II clinical study, aiming to observe and evaluate, as well as explore the efficacy and safety of precision targeted therapy based on NGS technology for…
- Trial name
- NCT07282262
- Testing
- Ivosidenib, Lenvatinib, PD-1/PD-L1 inhibitor
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Peking Union Medical College Hospital
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
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
Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of…
- Trial name
- NCT07604064
- Testing
- Olutasidenib
- Where
- Japan
- Volunteers
- 3 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Acute Myeloid Leukemia (AML)
An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate…
- Trial name
- NCT05907057
- Testing
- Ivosidenib 500mg Oral Tablet, Azacitidine
- Where
- 15 sites in Austria, France and 2 more
- Volunteers
- 245 people
- Sponsor
- Servier Affaires Médicales
Acute Myeloid Leukemia, IDH1 Mutation
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
The purpose of this study is as follows: 1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy…
- Trial name
- OLUVENAZA (NCT06782542)
- Testing
- Olutasidenib, Venetoclax, Azacitidine
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Justin Watts, MD
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
Acute Myeloid Leukemia
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
- Trial name
- NCT06387069
- Testing
- HMPL-306 Regimen, Salvage Chemotherapy Regimen
- Where
- 53 sites in China
- Volunteers
- 316 people
- Sponsor
- Hutchmed
Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia (AML), Untreated AML, Other IDH1-mutated Positive Hematologic Malignancies, Myelodysplastic Syndromes
- Trial name
- NCT02074839
- Testing
- AG-120
- Where
- 30 sites in United States, France
- Volunteers
- 291 people
- Sponsor
- Institut de Recherches Internationales Servier
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying…
- Trial name
- NCT07912398
- Testing
- HMPL-306 tablet
- Volunteers
- 210 people
- Sponsor
- Hutchmed