NCT06917911From ClinicalTrials.govRecruiting

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)

Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

Core Binding Factor Acute Myeloid Leukemia

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: National Cancer Institute (NCI)
Enrolment target: 162
Started: 2 February 2027
Main results due: 25 November 2027
Study sites: 66
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 59 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(66)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Recruiting
Memorial Hospital West
Pembroke Pines, Florida, United States
Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, United States
Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, United States
Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, United States
Recruiting
Tufts Medical Center
Boston, Massachusetts, United States
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, United States
Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Recruiting
Billings Clinic Cancer Center
Billings, Montana, United States
Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Recruiting
Community Medical Center
Missoula, Montana, United States
Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Recruiting
University of Rochester
Rochester, New York, United States
Recruiting
State University of New York Upstate Medical University
Syracuse, New York, United States
Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Recruiting
Geisinger Medical Center
Danville, Pennsylvania, United States
Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, United States
Recruiting

Showing 60 of 66 sites — filter to narrow it down. 66 of the 66 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06917911. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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