Actively Recruiting
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-06
42
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).
CONDITIONS
Official Title
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Have newly diagnosed acute myeloid leukemia according to World Health Organization criteria
- Have an IDH1 mutation with specific substitutions (R132C, R132G, R132H, R132L, or R132S)
- Have an Eastern Cooperative Oncology Group performance status score of 0 to 2
- Have adequate liver function with bilirubin and liver enzymes within specified limits
- Have adequate kidney function with serum creatinine and creatinine clearance within specified limits
- Agree to serial blood and bone marrow sampling
- Be able to understand and willing to sign informed consent
- Willing to complete quality of life assessments during and after treatment
- If female with reproductive potential, have a negative pregnancy test and agree to use two forms of contraception during and 90 days after treatment
You will not qualify if you...
- Have received prior treatment for AML except non-oncologic treatments like hydroxyurea or leukapheresis
- Have received hypomethylating agents for myelodysplastic syndrome
- Have favorable risk cytogenetics such as t(8;21), inv(16), t(16;16), or t(15;17)
- Have acute promyelocytic leukemia
- Have received treatment for antecedent hematologic disorders without proper washout
- Have prior treatment with IDH1 or BCL-2 inhibitors
- Have known allergy to ivosidenib, venetoclax, or azacitidine
- Are pregnant or breastfeeding
- Are taking strong CYP3A4 inducers or sensitive CYP3A4 substrates unless switched prior to dosing
- Have uncontrolled systemic infections
- Have a history of malignancy other than MDS or myeloproliferative disorder unless disease-free for at least 1 year
- Have had significant active heart disease within 6 months
- Have prolonged QT interval or risk factors increasing QT prolongation
- Have uncontrolled hepatitis B, hepatitis C, or HIV infection
- Have conditions limiting oral drug absorption
- Have uncontrolled hypertension
- Have active central nervous system leukemia or related symptoms
- Have life-threatening leukemia complications
- Have medical or psychological conditions interfering with consent or participation
- Are taking medications that prolong QT interval unless properly managed
- Have history of progressive multifocal leukoencephalopathy
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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