OncoMatch/Clinical Trials/NCT07007949
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
Is NCT07007949 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Ivosidenib combined with venetoclax and azacitidine and Ivosidenib combined with venetoclax and azacitidine for acute myeloid leukemia.
Treatment: Ivosidenib combined with venetoclax and azacitidine · Ivosidenib combined with venetoclax and azacitidine — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 r132c
Required: IDH1 r132g
Required: IDH1 r132h
Required: IDH1 r132l
Required: IDH1 r132s
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: AML therapy
Exception: nononcolytic treatments to stabilize disease such as hydroxyurea or leukapheresis
Have received any prior treatment for AML with the exception of nononcolytic treatments to stabilize disease such as hydroxyurea or leukapheresis.
Cannot have received: hypomethylating agent
Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
Cannot have received: IDH1 inhibitor
Have received prior treatment with an IDH1 inhibitor
Cannot have received: BCL-2 inhibitor
Have received prior treatment with a BCL-2 inhibitor
Lab requirements
Kidney function
serum creatinine ≤2.0 x ULN or creatinine clearance >30 mL/min based on Cockcroft-Gault glomerular filtration rate
Liver function
Serum total bilirubin ≤2 × ULN, unless considered to be due to Gilbert's disease or underlying leukemia, where it must be <3 x ULN. AST, ALT, and ALP ≤3.0 × ULN, unless considered to be due to underlying leukemia.
Cardiac function
QTcF >470 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (eg, NYHA Class III or IV congestive heart failure, hypokalemia, family history of long QT interval syndrome) [excluded]
Have adequate hepatic function, as evidenced by: Serum total bilirubin ≤2 × ULN, unless considered to be due to Gilbert's disease or underlying leukemia, where it must be <3 x ULN. AST, ALT, and ALP ≤3.0 × ULN, unless considered to be due to underlying leukemia. Have adequate renal function, as evidenced by serum creatinine ≤2.0 x ULN or creatinine clearance >30 mL/min based on the Cockcroft-Gault glomerular filtration rate. QTcF >470 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (eg, NYHA Class III or IV congestive heart failure, hypokalemia, family history of long QT interval syndrome) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07007949 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IDH1?
Yes, IDH1 r132c is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 r132g is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 r132h is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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