Sign in

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)
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

Full criteria on ClinicalTrials.gov

Sites (81)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
San Juan City Hospital
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
Centro Comprensivo de Cancer de UPR
Coordinator of this site? Confirm its status
San JuanPuerto RicoRecruiting
University of New Mexico Cancer Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
Community Hospital of Anaconda
Coordinator of this site? Confirm its status
AnacondaUnited StatesRecruiting
Our Lady of the Lake Physician Group
Coordinator of this site? Confirm its status
Baton RougeUnited StatesRecruiting
Nebraska Medicine-Bellevue
Coordinator of this site? Confirm its status
BellevueUnited StatesRecruiting
Billings Clinic Cancer Center
Coordinator of this site? Confirm its status
BillingsUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Prisma Health Cancer Institute - Spartanburg
Coordinator of this site? Confirm its status
Boiling SpringsUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Tufts Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Bozeman Health Deaconess Hospital
Coordinator of this site? Confirm its status
BozemanUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Coordinator of this site? Confirm its status
BrightonUnited StatesRecruiting
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Coordinator of this site? Confirm its status
CantonUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Coordinator of this site? Confirm its status
ChelseaUnited StatesRecruiting
Rush MD Anderson Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Illinois
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
Coordinator of this site? Confirm its status
Coeur d'AleneUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Coordinator of this site? Confirm its status
ColliervilleUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
Coordinator of this site? Confirm its status
Creve CoeurUnited StatesRecruiting
UChicago Medicine Northwest Indiana
Coordinator of this site? Confirm its status
Crown PointUnited StatesRecruiting
Geisinger Medical Center
Coordinator of this site? Confirm its status
DanvilleUnited StatesRecruiting
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Prisma Health Cancer Institute - Easley
Coordinator of this site? Confirm its status
EasleyUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
Coordinator of this site? Confirm its status
EdmondsUnited StatesRecruiting
University of Kansas Clinical Research Center
Coordinator of this site? Confirm its status
FairwayUnited StatesRecruiting
Benefis Sletten Cancer Institute
Coordinator of this site? Confirm its status
Great FallsUnited StatesRecruiting
Prisma Health Cancer Institute - Faris
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Butternut
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Eastside
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
Prisma Health Cancer Institute - Greer
Coordinator of this site? Confirm its status
GreerUnited StatesRecruiting
Baptist Cancer Center-Grenada
Coordinator of this site? Confirm its status
GrenadaUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
Coordinator of this site? Confirm its status
IssaquahUnited StatesRecruiting
Logan Health Medical Center
Coordinator of this site? Confirm its status
KalispellUnited StatesRecruiting
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Gundersen Lutheran Medical Center
Coordinator of this site? Confirm its status
La CrosseUnited StatesRecruiting
UC San Diego Moores Cancer Center
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Coordinator of this site? Confirm its status
LivoniaUnited StatesRecruiting
The James Graham Brown Cancer Center at University of Louisville
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
UofL Health Medical Center Northeast
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
Coordinator of this site? Confirm its status
Menomonee FallsUnited StatesRecruiting
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesRecruiting
Community Medical Center
Coordinator of this site? Confirm its status
MissoulaUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Union County
Coordinator of this site? Confirm its status
New AlbanyUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
Coordinator of this site? Confirm its status
New BerlinUnited StatesRecruiting
UC Comprehensive Cancer Center at Silver Cross
Coordinator of this site? Confirm its status
New LenoxUnited StatesRecruiting
Drexel Town Square Health Center
Coordinator of this site? Confirm its status
Oak CreekUnited StatesRecruiting
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Nebraska Medicine-Village Pointe
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
University of Chicago Medicine-Orland Park
Coordinator of this site? Confirm its status
Orland ParkUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
Coordinator of this site? Confirm its status
Overland ParkUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Coordinator of this site? Confirm its status
OxfordUnited StatesRecruiting
Memorial Hospital West
Coordinator of this site? Confirm its status
Pembroke PinesUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Coordinator of this site? Confirm its status
PontiacUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
Coordinator of this site? Confirm its status
Post FallsUnited StatesRecruiting
Rhode Island Hospital
Coordinator of this site? Confirm its status
ProvidenceUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Huntsman Cancer Institute/University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
Coordinator of this site? Confirm its status
SandpointUnited StatesRecruiting
Swedish Medical Center-First Hill
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Prisma Health Cancer Institute - Seneca
Coordinator of this site? Confirm its status
SenecaUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Coordinator of this site? Confirm its status
SouthhavenUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
State University of New York Upstate Medical University
Coordinator of this site? Confirm its status
SyracuseUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
Coordinator of this site? Confirm its status
West BendUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
Coordinator of this site? Confirm its status
WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
Coordinator of this site? Confirm its status
Wilkes-BarreUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Coordinator of this site? Confirm its status
YpsilantiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.