Recruiting
Phase 2

Venetoclax vs. Gemtuzumab

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06917911

Conditions

Core Binding Factor Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspiration

Cytarabine

Daunorubicin Hydrochloride

Echocardiography Test

Study Details

Brief summary:

This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). 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. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine 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. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

Conditions

Core Binding Factor Acute Myeloid Leukemia

Study ID

NCT06917911

Start date

Feb 2, 2027

Status verified date

Aug, 2026

Completion date

Nov 25, 2027

Anticipated

Primary completion date

Nov 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regimen 1 (gemtuzumab ozogamicin 7+3)

Patients receive gemtuzumab ozogamicin IV on day 1, 2 or 3 and on day 4, 5, or 6 (NOTE: two doses must be at least 3 days apart), as well as cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study.

experimental: Regimen 2 (Venetoclax, 7+3)

Patients receive venetoclax orally (PO) once daily (QD) on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration, as well as blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspiration

Undergo bone marrow aspiration

Cytarabine

Given IV

Daunorubicin Hydrochloride

Given IV

Echocardiography Test

Undergo echocardiography

Gemtuzumab Ozogamicin

Given IV

Multigated Acquisition Scan

Undergo MUGA scan

Venetoclax

Given PO

Primary outcome measure

  • Complete remission without measurable residual disease (CRMRD-) [ Time Frame: At end of induction (Up to 28 days) ]

Central Contacts and Locations

Locations

Memorial Hospital West

Recruiting

Pembroke Pines, Florida, United States, 33028

Contacts

Site Public Contact

954-265-4325

Principal Investigator:

Yehuda E. Deutsch

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Yuchen Liu

University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Jesus Gonzalez Lugo

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Jesus Gonzalez Lugo

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Jesus Gonzalez Lugo

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Jesus Gonzalez Lugo

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Fevzi Yalniz

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Mohamed M. Hegazi

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Site Public Contact

502-852-2755ctoinfo@louisville.edu

Principal Investigator:

Mohamed M. Hegazi

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Site Public Contact

617-636-5000ContactUsCancerCenter@TuftsMedicalCenter.org

Principal Investigator:

Andreas K. Klein

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Baptist Cancer Center-Grenada

Recruiting

Grenada, Mississippi, United States, 38901

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Union County

Recruiting

New Albany, Mississippi, United States, 38652

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Ramzi Abboud

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Ramzi Abboud

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Michael Haddadin

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Michael Haddadin

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Michael Haddadin

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Eunice S. Wang

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Bassil Botros

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Teresa C. Gentile

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Ioannis Mantzaris

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Harry P. Erba

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Zimu Gong

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph J. Vadakara

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Baptist Memorial Hospital and Cancer Center-Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Paul J. Shami

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Site Public Contact

608-775-2385cancerctr@gundersenhealth.org

Principal Investigator:

Michael O. Ojelabi

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.