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RECRUITING Phase 2 ClinicalTrials.gov

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)

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06917911

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Bone Marrow Aspiration (Procedure)
    Undergo bone marrow aspiration
  • Cytarabine (Drug)
    Given IV
  • Daunorubicin Hydrochloride (Drug)
    Given IV
  • Echocardiography Test (Procedure)
    Undergo echocardiography
  • Gemtuzumab Ozogamicin (Drug)
    Given IV
  • Multigated Acquisition Scan (Procedure)
    Undergo MUGA scan
  • Venetoclax (Drug)
    Given PO

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

Conditions

Core Binding Factor Acute Myeloid Leukemia

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Memorial Hospital West — Pembroke Pines, Florida, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Kansas Clinical Research Center — Fairway, Kansas, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle — Columbus, Mississippi, United States
  • Baptist Cancer Center-Grenada — Grenada, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Union County — New Albany, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Oxford — Oxford, Mississippi, United States
  • Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
  • Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • University of Rochester — Rochester, New York, United States
  • State University of New York Upstate Medical University — Syracuse, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Prisma Health Cancer Institute - Spartanburg — Boiling Springs, South Carolina, United States
  • Prisma Health Cancer Institute - Easley — Easley, South Carolina, United States
  • Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
  • Prisma Health Cancer Institute - Greer — Greer, South Carolina, United States
  • Prisma Health Cancer Institute - Seneca — Seneca, South Carolina, United States
  • Baptist Memorial Hospital and Cancer Center-Collierville — Collierville, Tennessee, United States
  • Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
  • Swedish Cancer Institute-Issaquah — Issaquah, Washington, United States
  • Swedish Medical Center-First Hill — Seattle, Washington, United States
  • Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
  • Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico
  • San Juan City Hospital — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record