RecruitingPhase 2NCT07228273

Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia

A Phase II Randomized Clinical Trial of Venetoclax Combined With FLAG IDA Induction and Consolidation Compared to Standard of Care for Newly Diagnosed Patients With Acute Myeloid Leukemia

Sponsor

OHSU Knight Cancer Institute

Enrollment

102 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination of chemotherapy drugs — fludarabine, cytarabine, idarubicin, and venetoclax — as induction and consolidation treatment for newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), with the goal of preparing patients for a stem cell transplant. **You may be eligible if...** - You are between 18 and 65 years old with newly diagnosed AML or high-risk MDS - You have not received prior treatment for AML or MDS (though hydroxyurea and limited cytarabine for disease control are allowed) - You are willing and eligible to receive a stem cell transplant - Your general health is good (ECOG 0 or 1) with adequate heart, kidney, and liver function - You are able to take medications by mouth or feeding tube **You may NOT be eligible if...** - You have received prior treatment for AML or MDS (beyond brief cytoreduction) - You are not willing to pursue a stem cell transplant - You have poor organ function, significant heart problems, or severely impaired kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

DRUGCytarabine

Given IV

DRUGDaunorubicin

Given IV

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGFludarabine

Given IV

DRUGIdarubicin

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

OTHERQuestionnaire Administration

Ancillary studies

DRUGVenetoclax

Given PO

Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT07228273

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