OncoMatch/Clinical Trials/NCT07228273
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Is NCT07228273 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for acute myeloid leukemia.
Treatment: Cytarabine · Daunorubicin · Fludarabine · Idarubicin · Venetoclax — This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Excluded: FLT3 ITD
mutation(s) to FLT3 ITD ... Point mutations within the tyrosine kinase domain (FLT3 TKD) are allowed
Excluded: RUNX1T1 fusion
core binding factor (CBF)
Excluded: CBFB fusion
core binding factor (CBF)
Excluded: PML fusion
t(15;17) (acute promyelocytic leukemia [APL])
Excluded: RARA fusion
t(15;17) (acute promyelocytic leukemia [APL])
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: BCL 2 inhibitor
Prior treatment with a BCL 2 inhibitor within 12 months prior to the start of treatment
Cannot have received: investigational therapy
Exception: hydroxyurea or cytarabine for cytoreduction purposes
Currently receiving investigational therapy or chemotherapy within 28 days, or 5 half-lives, whichever is longer, with the exception of hydroxyurea or cytarabine for cytoreduction purposes
Cannot have received: chemotherapy
Exception: hydroxyurea or cytarabine for cytoreduction purposes
Currently receiving investigational therapy or chemotherapy within 28 days, or 5 half-lives, whichever is longer, with the exception of hydroxyurea or cytarabine for cytoreduction purposes
Lab requirements
Blood counts
Adequate hematologic function; WBC > 25 x 10^9/L excluded
Kidney function
Calculated creatinine clearance (Cockcroft-Gault) > 40 mL/min
Liver function
AST/ALT ≤ 3 x ULN, unless considered due to leukemic involvement; total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's disease or leukemic involvement
Cardiac function
NYHA criteria for cardiac function; LVEF < 40% excluded; history of NYHA class III or IV CHF excluded; unstable/uncontrolled angina, severe/uncontrolled ventricular arrhythmias, or MI within 6 months excluded
Adequate hematologic and organ function; Institutional standards, New York Heart Association (NYHA) criteria for cardiac function; Calculated creatinine clearance (Cockcroft-Gault) > 40 mL/min; AST/ALT ≤ 3 x ULN, unless considered due to leukemic involvement; total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's disease or leukemic involvement
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07228273 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.
Are patients with FLT3 alterations eligible?
No. FLT3 ITD is an exclusion criterion.
Are patients with RUNX1T1 alterations eligible?
No. RUNX1T1 fusion is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify