Testing Venetoclax or Gemtuzumab Ozogamicin for Core Binding Factor Acute Myeloid Leukemia
This study is for people aged 18 to 59 with a type of blood cancer called Core Binding Factor Acute Myeloid Leukemia (CBF-AML) who have not had prior cancer treatment for AML. It compares two different additions to the standard "7+3" chemotherapy (cytarabine and daunorubicin). One addition is venetoclax, which works by blocking a protein cancer cells need to survive. The other is gemtuzumab ozogamicin, a targeted therapy that delivers a drug to kill cancer cells by attaching to specific markers on their surface. The main goal is to see if adding either venetoclax or gemtuzumab ozogamicin leads to a complete remission (when the cancer is no longer detectable) without measurable residual disease after initial treatment. About 162 people are planned to join this study.
- Study design
- This is a Phase II interventional study comparing two different treatment arms. It plans to enroll 162 participants.
- What's involved
- You would undergo bone marrow aspirations and biopsies, and may have optional buccal cell and blood sample collections. The primary endpoint is measured at the end of induction (up to 28 days).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at the end of induction (up to 28 days). Other outcomes like overall survival and event-free survival will also be compared, implying longer-term follow-up.
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NCT06917911
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Recruiting
PHASE2Ages 18–59InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~162 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationCytarabineDaunorubicin HydrochlorideEchocardiography TestGemtuzumab Ozogamicin
At a glance
Recruiting sites
51 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete remission without measurable residual disease (CRMRD-)
Measured over At end of induction (Up to 28 days)
Conditions
Where it's being run
51 sites across 17 statesSouth Carolina7
Michigan6
Mississippi5
Missouri5
Kansas4
Montana4
Idaho3
Kentucky3
Study leadership
- Celalettin Ustun · PRINCIPAL_INVESTIGATOR · Alliance for Clinical Trials in Oncology
Who to contact
Site Public Contact
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team
GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS)
Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed.
Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility
GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed
Diagnosis of AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study)
Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed.
No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted
Age 18-59 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN)
Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m\^2
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required
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
Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease
Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
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 II or better
No known medical condition causing an inability to swallow oral formulations of agents
What this trial measures
- Complete remission without measurable residual disease (CRMRD-)At end of induction (Up to 28 days)
MRD will be evaluated by Molecular Diagnostics Network flow cytometry and will be defined at a threshold of ≤ 10\^-3.