Actively Recruiting
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Led by OHSU Knight Cancer Institute · Updated on 2026-01-22
102
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and provide written informed consent
- Age between 18 and 65 years at consent
- All genders, races, and ethnicities eligible
- Newly diagnosed, untreated AML or MDS with marrow blasts 10% or more, according to 2022 European LeukemiaNet criteria
- Allowed prior cytoreduction treatment with cytarabine or hydroxyurea under specific limits
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willingness to undergo hematopoietic stem cell transplant (HSCT)
- Ability to take oral medications or feeding tube
- Adequate blood counts and organ function
- Cardiac function meeting institutional and New York Heart Association (NYHA) standards
- Creatinine clearance over 40 mL/min
- Liver enzymes (AST and ALT) up to three times the upper limit of normal unless due to leukemia
- Total bilirubin up to 1.5 times upper limit of normal unless due to Gilbert's disease or leukemia
- Willing and able to follow study schedule, provide bone marrow samples, and accept supportive care
- Negative pregnancy test within 3 days before treatment start if of childbearing potential
- Agreement to use approved contraception and avoid sperm or ovum donation during and after treatment as specified
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or certain FLT3 or core binding factor mutations
- Another active cancer within past 5 years except certain treated skin cancers
- Known active central nervous system involvement with AML
- Major surgery within 28 days before treatment
- Graft-versus-host disease or autologous stem cell transplant within 100 days before treatment
- Receiving investigational therapy or chemotherapy within 28 days except allowed cytoreduction
- Prior treatment with BCL-2 inhibitors within 12 months before treatment
- Use of certain interacting medications within 2 days before starting venetoclax unless dose adjusted
- Allergy to study drugs or their ingredients
- Poor organ function including severe heart failure, unstable heart conditions, recent heart attack, or very high white blood cell count
- Difficulty swallowing without feeding tube or other absorption issues
- Active liver disease or positive hepatitis B or C unless virus undetectable for 3 months
- HIV infection treated with certain therapies that interfere with study drugs
- Uncontrolled infection or recent fever requiring treatment
- Psychiatric or social issues limiting study compliance
- Unwillingness to stop breastfeeding during the study and for 6 weeks after last dose of study drug
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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