OncoMatch/Clinical Trials/NCT07392242
A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia
Is NCT07392242 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivosidenib and Azacitidine for acute myeloid leukemia.
Treatment: Ivosidenib · Azacitidine · Venetoclax — The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 R132 mutation
Participant has IDH1-R132 mutation present prior to initiating Ivo/Aza/Ven confirmed by CLIA approved local testing via next-generation sequencing (NGS) and/or polymerase chain reaction (PCR).
Allowed: IDH1 other 2-HG producing IDH1 variants
Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator.
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: (ivosidenib, venetoclax)
Participants who have previously received ivosidenib or venetoclax
Lab requirements
Blood counts
WBC count <25,000/μL at initiation of study drug (leukapheresis or hydroxyurea permitted to reduce WBC)
Kidney function
serum creatinine < 2 x ULN or creatinine clearance 30 mL/min (Cockroft-Gault)
Liver function
AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement; serum total bilirubin < 3.0 x ULN (higher levels acceptable if attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome)
Cardiac function
QTcF < 450 ms (mean of triplicate ECG); no significant active cardiac disease within 6 months (NYHA class III/IV CHF, ACS, stroke)
Participant must have a WBC count <25,000/μL at the time of initiation of study drug (leukapheresis may be performed and/or hydroxyurea may be administered to decrease the WBC count to <25,000/μL). Participant has adequate organ function defined as: AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement. Serum total bilirubin < 3.0 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome. Serum creatinine < 2 x ULN or creatinine clearance 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation. QTc interval (i.e., Fridericia's correction [QTcF]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Participants with a QTcF over 450 ms due
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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