Clinical trials: IDH1 Mutation, open to volunteers
Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib.
- Trial name
- CHONQUER (NCT06127407)
- Testing
- Ivosidenib 500mg
- Where
- 115 sites in United States, Australia and 15 more
- Volunteers
- 156 people
- Sponsor
- Servier Bio-Innovation LLC
IDH1 Mutation, Acute Myeloid Leukemia (AML)
Ivosidenib as Post-HSCT Maintenance for AML
This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).
- Conditions
- IDH1 Mutation, Acute Myeloid Leukemia (AML), Hematopoietic Stem Cell Transplant (HSCT)
- Trial name
- NCT06707493
- Testing
- Ivosidenib
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- Massachusetts General Hospital
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
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.)
IDH1 Mutation, Relapsed / Refractory AML
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens.
- Trial name
- NCT07471841
- Testing
- Olutasidenib, Azacitidine (AZA)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Timothy Pardee
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
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or…
- Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- Trial name
- NCT07712757
- Testing
- Safusidenib
- Volunteers
- 140 people
- Sponsor
- Nuvation Bio Inc.
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
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.
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
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
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
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
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