Core Binding Factor Acute Myeloid LeukemiaPhase 2NCT06917911
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)
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Cytarabine in people with Core Binding Factor Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 73 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Core Binding Factor Acute Myeloid Leukemia
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 73 sitesin 2 countries
- Study dates
- 28 Sep 2026to 25 Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
73 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
73 sites in 2 countries
United States71 sites, 71 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Charles Foucar
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Harry G. Sequeira Gross
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Michael Haddadin
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Razan Mohty
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Andreas K. Klein
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Eric S. Winer
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Eunice S. Wang
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Yuchen Liu
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Alice S. Mims
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Joseph J. Vadakara
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Harry P. Erba
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Jesus Gonzalez Lugo
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Jesus Gonzalez Lugo
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Michael O. Ojelabi
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Tiffany N. Tanaka
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Fevzi Yalniz
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Mohamed M. Hegazi
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu
Mohamed M. Hegazi
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Ehab L. Atallah
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Ehab L. Atallah
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Ehab L. Atallah
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Ehab L. Atallah
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Zimu Gong
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Michael Haddadin
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Michael Haddadin
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Jesus Gonzalez Lugo
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Memorial Hospital West
Pembroke Pines, Florida, 33028
Site Public Contact, 954-265-4325
Yehuda E. Deutsch
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
John L. Reagan
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Bassil Botros
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Paul J. Shami
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Salil Goorha
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Site Public Contact, 315-464-5476
Teresa C. Gentile
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Ioannis Mantzaris
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Ehab L. Atallah
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Jesus Gonzalez Lugo
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Joseph J. Vadakara
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Compare the rates of complete remission (CR) without measurable residual disease (CRMRD-) by multiparameter flow cytometry following induction therapy between the two treatment arms in each cohort separately.
SECONDARY OBJECTIVES:
- To compare the rates of CR and composite complete remission (CRc) (CR+complete remission with incomplete hematologic recovery [CRi]+complete remission with partial hematologic recovery [CRh]) between the treatment arms.
II. To compare the overall survival (OS) between the treatment arms. III. To compare the event-free survival (EFS). IV. To compare the cumulative incidence of relapse (CIR). V. To compare the cumulative incidence of death (CID) between the treatment arms.
VI. To compare the rate of early death at 30 days and 60 days between the treatment arms.
VII. To assess the rate and frequency of adverse events between treatment arms. VIII. To evaluate mutant RAS and mutant KIT as predictive biomarkers for CRMRD- rate in CBF AML.
EXPLORATORY OBJECTIVE:
- To compare MRD (and its clinical implication, e.g., relapse rates) between flow cytometry (FC) and next generation sequencing (NGS)-based (RUNX1::RUNX1T1 or CBFB::MYH11).
CORRELATIVE OBJECTIVES:
- To evaluate the frequency and clinical impact of variant allele frequency (VAF) of KIT mutation, KIT mutations in different exons (e.g., exon 8 or 17), CD33 expression, additional (secondary) mutations and cytogenetic abnormalities.
II. To evaluate the differences in clinical and molecular outcomes in patients with RUNX1::RUNX1T1 mutated versus CBFB::MYH11 mutated CBF AML.
OUTLINE: Patients are randomized to 1 of 2 regimens.
REGIMEN 1: Patients receive gemtuzumab ozogamicin intravenously (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 multigated acquisition (MUGA) scan during screening, as well as bone marrow aspiration and blood sample collection throughout the study.
REGIMEN 2: 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.
After completion of study treatment, patients are followed up at relapse and every 3 months for 2 years, then every 6 months until 5 years.
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Echocardiography Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
CytarabineDrug
Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Given IV
Daunorubicin HydrochlorideDrug
Also called Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
Gemtuzumab OzogamicinDrug
Also called Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab
Given IV
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA scan
VenetoclaxDrug
Also called ABT 199, ABT-0199, ABT-199, ABT199
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 (gemtuzumab ozogamicin 7+3) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Procedure: Echocardiography Test; Drug: Gemtuzumab Ozogamicin; Procedure: Multigated Acquisition Scan |
| Regimen 2 (Venetoclax, 7+3) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission without measurable residual disease (CRMRD-)
MRD will be evaluated by Molecular Diagnostics Network flow cytometry and will be defined at a threshold of ≤ 10^-3.
Measured: At end of induction (Up to 28 days)
Secondary outcomes (10)
Rate of complete remission (CR)
Defined as the number of evaluable patients achieving a response of CR per European Leukemia Network (ELN) 2022 criteria at the end of treatment divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for CR rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
Measured: At the end of treatment (Up to 28 days)
Rate of composite CR
Defined as the number of evaluable patients achieving a response of CR or complete remission with incomplete hematologic recovery (CRi) or complete remission with partial hematologic recovery (CRh) per ELN 2022 criteria at the end of treatment divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for CR rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
Measured: At the end of treatment (Up to 28 days)
Overall survival (OS)
The distribution of OS will be estimated using method of Kaplan-Meier. The median OS and 95% confidence interval will be reported.
Measured: From registration until death due to any cause, up to 5 years
Event free survival (EVS)
Induction failure is defined as not achieving either CR, CRh or CRi by after induction therapy. The distribution of EFS will be estimated using method of Kaplan-Meier, and compared using log-rank tests. The median EFS and the corresponding 95% confidence interval will be reported.
Measured: From randomization to induction failure, hematologic relapse from CR/CRh/CRi or death from any cause, whichever occurs first, up to 5 years
Cumulative incidence of relapse (CIR)
The distribution of CIR will be estimated using Fine-Gray model and reported via hazard ratios and 95% confidence interval with p values.
Measured: From the date of achievement of a remission until the date of hematologic relapse, up to 5 years
Cumulative incidence of death (CID)
The distribution of CID will be estimated using Fine-Gray model and reported via hazard ratios and 95% confidence interval with p values.
Measured: From the date of achievement of a remission to death without prior relapse, up to 5 years
Rate of early death at 30 days (ED-30)
ED-30 is defined as the total number of patients who died on or before day 30 from randomization divided by the total number of evaluable patients. Rate of early death at day 30 will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for ED-30 rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
Measured: At 30 days
Rate of early death at 60 days (ED-60)
ED-60 is defined as the total number of patients who died on or before day 60 from randomization divided by the total number of evaluable patients. Rate of early death at day 60 will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for ED-60 rate within each arm along with 95% confidence intervals using the Clopper-Pearson method.
Measured: At 60 days
Incidence of adverse events
As per national Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm and will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.
Measured: Up to 5 years
Evaluate mutant RAS and mutant KIT as predictive biomarkers for CRMRD- rate
In cohort 1, subgroup analysis will be conducted to evaluate the treatment effect among RAS mutated patients using Kaplan Meier methods and log-rank tests; similar subgroup analysis will be done among KIT mutated patients.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start28 Sep 2026
- Primary completion25 Nov 2027 (estimated)
- Study completion25 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core Binding Factor Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Celalettin Ustun, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917911
- Sponsor's protocol ID
- NCI-2025-02426
- Other IDs
- NCI-2025-02426, MM1YA-A04, MM1YA-A04, U10CA180821
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.