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Phase II Study for Acute Myeloid Leukemia and Myelodysplastic Syndrome

This study is testing two different treatment approaches for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). One approach uses a combination of fludarabine, cytarabine, idarubicin, and venetoclax. The other uses cytarabine and daunorubicin. Researchers want to see if these treatments can get your AML under control (induction therapy) and then keep it away (consolidation therapy). The main goal is to see how many participants achieve a complete remission where very few cancer cells are left (measurable residual disease negative composite complete remission). You may be able to join if you are 18 to 65 years old and have newly diagnosed, untreated AML or MDS with at least 10% blast cells in your bone marrow. The study aims to enroll 102 participants.

Study design
This is a Phase II interventional study comparing two different drug combinations for AML and MDS. It plans to enroll 102 participants.
What's involved
You would undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy. You would also receive intravenous (IV) medications.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 30 days after your last dose of study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07228273

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
OHSU Knight Cancer Institute
~102 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyCytarabineDaunorubicinEchocardiography Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants achieving measurable residual disease negative composite complete remission (CRc-MRD-)
Measured over Up to 30 days post last dose of study drug

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Curtis A Lachowiez · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Curtis A. Lachowiez
[email protected]
503-494-6157
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability to comprehend the investigational nature of the study and provide written informed consent
Age 18 to ≤ 65 years (yrs), at the time of consent
All gender identities, races, or ethnicities are eligible
Newly documented, previously untreated diagnosis of AML or myelodysplastic syndrome (MDS) with marrow blasts ≥ 10%, in agreement with 2022 European LeukemiaNet criteria (ELN22)
Leukapheresis and treatment with cytarabine or hydroxyurea prior to study initiation is permitted for cytoreduction in patients with proliferative disease. NOTE: Treatment with cytarabine is limited to up to 2 grams total at least 14 days prior to starting on protocol defined therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Willingness to undergo hematopoietic stem cell transplant (HSCT)
Ability to take medications by mouth or feeding tube
Adequate hematologic and organ function
Institutional standards, New York Heart Association (NYHA) criteria for cardiac function
Calculated creatinine clearance (according to the Cockcroft-Gault equation) \> 40 mL/min
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 3 x upper limit of normal (ULN), unless considered due to leukemic involvement
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN, unless considered due to leukemic involvement
Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's disease or leukemic involvement
Willing and able to
Adhere to study schedule of activities and lifestyle restrictions while on treatment;
Provide bone marrow (BM) aspirate and core biopsy samples; AND
Accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequelae, including transfusions
Negative pregnancy test within 3 days of start of treatment for persons of childbearing potential (PCBP)
Based on animal studies and the known pharmacology of the study drugs, PCBP and sperm-producing participants who are sexually active with a PCBP must comply with study requirements for contraception
PCBP (participants and PCBP partners of participants) must agree to use an approved contraception and to refrain from donating / cryopreserving ova from cycle (C) 1 day (D) 1 until 6 months following the last dose of study treatment
Participants who produce viable sperm and who have intercourse with PCBP must agree to use an approved contraception method and to refrain from donating sperm from C1D1 until 3 months following the last dose of study treatment

Exclusion

Documented t(15;17) (acute promyelocytic leukemia \[APL\]), and/or mutation(s) to FLT3 ITD or core binding factor (CBF). Point mutations within the tyrosine kinase domain (FLT3 TKD) are allowed
Another active malignancy within the previous 5 years, except treated early stage carcinomas of the skin, or at the investigator's discretion
Known, active central nervous system (CNS) involvement with AML
Recent and significant medical interventions, such as major surgery within 28 days of start of treatment
GVHD or autologous stem cell transplant within 100 days of start of treatment
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
Prior treatment with a BCL 2 inhibitor within 12 months prior to the start of treatment
Use of strong or moderate CYP3A4 inducers or inhibitors or P-gp inhibitors within 2 days or 3 half-lives, whichever is longer, prior to start of treatment with venetoclax or at the discretion of the investigator if dose reductions, based on the interaction, have been specified
History of allergic response to any of the interventional agents or any excipients in the formulations
Inadequate organ function, including the following (or at the discretion of the investigator):
History of New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 40% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Unstable/uncontrolled angina pectoris, history of severe and/or uncontrolled ventricular arrhythmias, or history of myocardial infarction within the last 6 months
A white blood cell count (WBC) \> 25 x 10\^⁹/L
Known dysphagia in the absence of a feeding tube, short-gut syndrome, or other conditions or causes that would affect the ingestion and/or gastrointestinal absorption of drugs administered orally
Active hepatic disorder or documented positive hepatitis B or C virus (HBV/HCV, respectively) status, except in cases of undetectable HBV/HCV viral load for at least 3 months prior to the start of treatment. (Hepatitis B or C testing is not required for eligibility assessment.)
Individuals with positive serology for human immunodeficiency virus (HIV) who are undergoing treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents) are not eligible. If the HIV infection is controlled with another medication type or if an acceptable alternative HIV treatment can be substituted for HAART, enrollment may proceed
Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to start of treatment and must be amenable to alternate treatment if current treatment will interact with investigational regimen
Psychiatric illness/social situations that would limit compliance with study requirements
Unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding is not allowed throughout the study for 6 weeks after the last dose of study drug

What this trial measures

  • Percentage of participants achieving measurable residual disease negative composite complete remission (CRc-MRD-)Up to 30 days post last dose of study drug

    Will be defined as the achievement of both measurable disease negative (MRD-) by multiparameter flow cytometry and complete response (CR), CR with partial hematologic recovery (CRh), or CR with incomplete blood count recovery (CRi). Participants who do not qualify as efficacy-evaluable (usually due to early death or withdrawal because of toxicity) will be considered non-responders. A point estimate and 95% exact confidence interval (CI) for CRc MRD- will be computed for each arm (and time point) separately and the CRc MRD- rate will be statistically compared across arms with Fisher's exact test at 3 timepoints: end of induction, end of the first consolidation cycle, and end of treatment. A Hochberg multiplicity adjustment will be applied to the p-values from these 3 Fisher exact tests to control the family wise error rate (at α=0.05) for between-arm comparisons of the primary endpoint. CRc MRD- status at each of the above-specified time points will be modeled with logistic regression.