Ivosidenib in Chinese patients with relapsed or refractory isocitrate dehydrogenase 1 mutated acute myeloid leukemia: a registry study.
Mingyuan Sun, Qingsong Yin, Yang Liang...
https://pubmed.ncbi.nlm.nih.gov/38911469Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID02074839
Study of Orally Administered AG-120 in Advanced Hematologic Malignancies With an IDH1 Mutation Evaluating Safety, Dose, and Clinical Activity
Led by Institut de Recherches Internationales Servier · Updated on 2025-06-08
291
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying AG-120, an oral drug, in adults with advanced blood cancers that have an IDH1 mutation. This Phase I, multicenter trial aims to find the safest dose, understand how the drug acts in the body, and evaluate its effects on the disease. The study includes patients with relapsed or refractory acute myeloid leukemia (AML), untreated AML, and other IDH1-mutated blood cancers, including myelodysplastic syndromes. The trial is sponsored by Institut de Recherches Internationales Servier and involves evaluating safety, pharmacokinetics, pharmacodynamics, and clinical activity.
CONDITIONS
Brief Title
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented IDH1 R132 gene-mutated advanced hematologic malignancy
- Ability to have serial bone marrow biopsies, peripheral blood, and urine sampling during the study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Platelet count of at least 20,000/µL (transfusions allowed to reach this count)
- Adequate liver function with AST, ALT, and ALP less than or equal to 3 times the upper limit of normal (ULN), unless related to leukemia, and total bilirubin less than or equal to 1.5 times ULN unless related to Gilbert's disease or leukemia
- Adequate kidney function with serum creatinine less than or equal to 2.0 times ULN or creatinine clearance above 40 mL/min
- Recovery from significant side effects of prior cancer treatments
- For females of childbearing potential, a negative pregnancy test within 7 days before starting treatment and on the first day of study drug administration
You will not qualify if you...
- Hematopoietic stem cell transplant within 60 days before first dose or current immunosuppressive therapy after transplant, or significant graft-versus-host disease (except stable oral or topical steroids for skin GVHD)
- Systemic anticancer therapy or radiotherapy within 14 days before first dose (hydroxyurea allowed before and after start)
- Investigational agent use within 14 days before first dose
- Pregnant or breastfeeding
- Active severe infection or unexplained fever above 38.5°C at screening or first dose day (tumor-related fever may be allowed)
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction below 40% within about 28 days before treatment
- Heart attack within 6 months before screening
- Unstable or uncontrolled angina or severe ventricular arrhythmias
- Prolonged QT interval (QTc ≥450 ms) or medications that prolong QT interval
- Known HIV infection or active hepatitis B or C
- Symptoms or known involvement of central nervous system leukemia
- Life-threatening severe leukemia complications such as uncontrolled bleeding, pneumonia with low oxygen or shock, or widespread clotting disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants take AG-120 orally every day in 28-day cycles until disease progression, unacceptable side effects, or hematopoietic stem cell transplant.
Visits occur regularly during treatment for safety and clinical assessments
Trial Site Locations
Total: 30 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Active, Not Recruiting
2
Mayo Clinic-AZ
Phoenix, Arizona, United States, 85259
Terminated
3
City of Hope
Duarte, California, United States, 91010
Active, Not Recruiting
4
University of California-Los Angeles
Los Angeles, California, United States, 90095
Terminated
5
University of California-San Francisco
San Francisco, California, United States, 94143
Terminated
6
University of Colorado Denver
Aurora, Colorado, United States, 80045
Terminated
7
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Terminated
8
University of Miami
Miami, Florida, United States, 33136
Terminated
9
Moffit Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
10
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
11
Northwestern University Medical Hospital
Chicago, Illinois, United States, 60611
Terminated
12
John Hopkins Cancer Center
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Terminated
14
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Terminated
15
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Terminated
16
Washington University
St Louis, Missouri, United States, 63110
Terminated
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Active, Not Recruiting
18
Cornell Cancer Center
New York, New York, United States, 10065
Terminated
19
Duke Cancer Center
Durham, North Carolina, United States, 27705
Terminated
20
Cleveland Clinic
Cleveland, Ohio, United States, 44124
Withdrawn
21
Ohio State University
Columbus, Ohio, United States, 43210
Terminated
22
Oregon Health and Science University
Portland, Oregon, United States, 97239
Terminated
23
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Terminated
25
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
27
Hopital La Timone
Marseille, France
Terminated
28
Hopital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
29
Central Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
30
Institute Gustave Roussly (IGR)
Villejuif, France, 94800
Actively Recruiting
Loading map...
Research Team
I
Institut de Recherches Internationales Servier Clinical Studies Department
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Final phase 1 substudy results of ivosidenib for patients with mutant IDH1 relapsed/refractory myelodysplastic syndrome.
Courtney D DiNardo, Gail J Roboz, Justin M Watts...
https://pubmed.ncbi.nlm.nih.gov/38640348Population pharmacokinetic and exposure-response analyses of ivosidenib in patients with IDH1-mutant advanced hematologic malignancies.
Xuemin Jiang, Russ Wada, Bill Poland...
https://pubmed.ncbi.nlm.nih.gov/33493392Molecular mechanisms mediating relapse following ivosidenib monotherapy in IDH1-mutant relapsed or refractory AML.
Sung Choe, Hongfang Wang, Courtney D DiNardo...
https://pubmed.ncbi.nlm.nih.gov/32380538Clinical pharmacokinetics and pharmacodynamics of ivosidenib in patients with advanced hematologic malignancies with an IDH1 mutation.
Bin Fan, David Dai, Courtney D DiNardo...
https://pubmed.ncbi.nlm.nih.gov/32296873Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia.
Gail J Roboz, Courtney D DiNardo, Eytan M Stein...
https://pubmed.ncbi.nlm.nih.gov/31841594Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.
Courtney D DiNardo, Eytan M Stein, Stéphane de Botton...
https://pubmed.ncbi.nlm.nih.gov/29860938Evidence for Clinical Differentiation and Differentiation Syndrome in Patients With Acute Myeloid Leukemia and IDH1 Mutations Treated With the Targeted Mutant IDH1 Inhibitor, AG-120.
K C Birendra, Courtney D DiNardo
https://pubmed.ncbi.nlm.nih.gov/27245312