Comparing Treatments for Intermediate Risk AML in Younger Patients
This study is for younger patients (ages 18-59) with a type of blood cancer called acute myeloid leukemia (AML). It compares three different treatment approaches: cytarabine and daunorubicin; cytarabine, daunorubicin, and venetoclax; or venetoclax and azacitidine. Cytarabine and daunorubicin are chemotherapy drugs that work by stopping cancer cell growth. Venetoclax is a different type of drug that targets a protein cancer cells need to survive. The main goal is to see which treatment best leads to undetectable measurable residual disease (MRD), meaning very few cancer cells remain after treatment. You must have specific genetic markers (actionable mutations) to be considered for this study, which will be identified through a separate screening process.
- Study design
- This is a Phase II interventional study with an estimated enrollment of 153 participants. Patients will be randomly assigned to one of three treatment groups.
- What's involved
- You would undergo procedures like blood sample collection and bone marrow aspirations. Treatments involve receiving drugs intravenously (IV) or subcutaneously (SC), and some orally, over cycles lasting up to 56 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for measuring treatment success is up to 2 cycles (56 days). Longer-term outcomes will also be evaluated.
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NCT05554393
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Recruiting
PHASE2Ages 18–59InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~153 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:AzacitidineBiospecimen CollectionBone Marrow AspirationCytarabineDaunorubicin HydrochlorideEchocardiography Test
At a glance
Recruiting sites
180 of 182 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurable residual disease (MRD) undetectable complete remission (CR)
Measured over Up to 2 cycles (56 days)
Conditions
Where it's being run
182 sites across 47 statesIllinois16
Michigan15
Minnesota11
Idaho10
New Jersey9
Wisconsin9
New York8
Pennsylvania7
Study leadership
- Mary L Savoie · PRINCIPAL_INVESTIGATOR · Canadian Cancer Trials Group
Who to contact
Site Public Contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH
Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
Previously untreated, de novo acute myeloid leukemia (AML) defined by \>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \[WHO\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:
Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
CEBPA biallelic mutations
NPM1 mutation
AML with PML-RARalpha
AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements
AML with FLT3-ITD mutation
Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease
Age 18-59 years at time of induction therapy
Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment)
Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \[SGPT\]) and/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 3 × institutional ULN (must be done within 10 days of enrollment)
Cardiac ejection fraction \>= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)
Calculated creatinine clearance \>= 30 mL/min; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment)
White blood cells (WBC) must be =\< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment
Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible
Exclusion
Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax
Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study
Patients with isolated myeloid sarcoma are not eligible
Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):
Active, uncontrolled bacterial, fungal, or viral infection
What this trial measures
- Measurable residual disease (MRD) undetectable complete remission (CR)Up to 2 cycles (56 days)
Will assess after one induction cycle with or without the addition of venetoclax or two cycles of venetoclax and azacitidine. MRD by flow cytometry will be considered undetectable if ≤ 10\^-3. The MRD negative CR will be assessed using European LeukemiaNet (ELN) 2017 criteria \[Döhner 2017\]. The analysis population for the primary outcome will be all randomized patients with the intent to treat population. The MRD undetectable CR rate will be the number of patients with MRD undetectable CR divided by the total number of patients. The differences of MRD undetectable CR rates between the experimental groups and the control group will be estimated and the corresponding one-sided 90% confidence limit will be calculated using Normal distribution approximation. MRD non-evaluable patients will be considered as MRD positive.