NCT06917911RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 28 Sept 2026
- Primary completion date
- 25 Nov 2027
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06917911
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 162
- From 28 Sept 2026 to the primary completion date, 25 Nov 2027
- 81 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (81)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Juan City Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Centro Comprensivo de Cancer de UPR Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Community Hospital of Anaconda Coordinator of this site? Confirm its status | Anaconda | United States | Recruiting |
| Our Lady of the Lake Physician Group Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Nebraska Medicine-Bellevue Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Billings Clinic Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Prisma Health Cancer Institute - Spartanburg Coordinator of this site? Confirm its status | Boiling Springs | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Bozeman Health Deaconess Hospital Coordinator of this site? Confirm its status | Bozeman | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Coordinator of this site? Confirm its status | Chelsea | United States | Recruiting |
| Rush MD Anderson Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| Kootenai Health - Coeur d'Alene Coordinator of this site? Confirm its status | Coeur d'Alene | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Collierville Coordinator of this site? Confirm its status | Collierville | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Recruiting |
| UChicago Medicine Northwest Indiana Coordinator of this site? Confirm its status | Crown Point | United States | Recruiting |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Prisma Health Cancer Institute - Easley Coordinator of this site? Confirm its status | Easley | United States | Recruiting |
| Swedish Cancer Institute-Edmonds Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| University of Kansas Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
| Benefis Sletten Cancer Institute Coordinator of this site? Confirm its status | Great Falls | United States | Recruiting |
| Prisma Health Cancer Institute - Faris Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Prisma Health Cancer Institute - Butternut Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Prisma Health Cancer Institute - Eastside Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Prisma Health Cancer Institute - Greer Coordinator of this site? Confirm its status | Greer | United States | Recruiting |
| Baptist Cancer Center-Grenada Coordinator of this site? Confirm its status | Grenada | United States | Recruiting |
| Swedish Cancer Institute-Issaquah Coordinator of this site? Confirm its status | Issaquah | United States | Recruiting |
| Logan Health Medical Center Coordinator of this site? Confirm its status | Kalispell | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Trinity Health Saint Mary Mercy Livonia Hospital Coordinator of this site? Confirm its status | Livonia | United States | Recruiting |
| The James Graham Brown Cancer Center at University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| UofL Health Medical Center Northeast Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Memphis Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Community Medical Center Coordinator of this site? Confirm its status | Missoula | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Union County Coordinator of this site? Confirm its status | New Albany | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross Coordinator of this site? Confirm its status | New Lenox | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nebraska Medicine-Village Pointe Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of Chicago Medicine-Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| University of Kansas Hospital-Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Oxford Coordinator of this site? Confirm its status | Oxford | United States | Recruiting |
| Memorial Hospital West Coordinator of this site? Confirm its status | Pembroke Pines | United States | Recruiting |
| Trinity Health Saint Joseph Mercy Oakland Hospital Coordinator of this site? Confirm its status | Pontiac | United States | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls Coordinator of this site? Confirm its status | Post Falls | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Kootenai Clinic Cancer Services - Sandpoint Coordinator of this site? Confirm its status | Sandpoint | United States | Recruiting |
| Swedish Medical Center-First Hill Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Prisma Health Cancer Institute - Seneca Coordinator of this site? Confirm its status | Seneca | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Desoto Coordinator of this site? Confirm its status | Southhaven | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.