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) (NCT06917911)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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
2. GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS)
3. Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed.
4. Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility
5. 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
6. 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)
7. Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy/radiation therapy) is allowed.
8. 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
9. Age 18-59 years
10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
11. 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)
12. Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x upper limit of normal (ULN)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (51 Sites)

• Memorial Hospital West — Pembroke Pines, Florida
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho
• Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho
• Northwestern University — Chicago, Illinois
• University of Kansas Clinical Research Center — Fairway, Kansas
• University of Kansas Cancer Center — Kansas City, Kansas
• University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky
• The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky
• UofL Health Medical Center Northeast — Louisville, Kentucky
• Tufts Medical Center — Boston, Massachusetts
• Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan
• Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan
• Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan
• Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan
• Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan
• Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan
• Baptist Memorial Hospital and Cancer Center-Golden Triangle — Columbus, Mississippi
• Baptist Cancer Center-Grenada — Grenada, Mississippi
• Baptist Memorial Hospital and Cancer Center-Union County — New Albany, Mississippi
• Baptist Memorial Hospital and Cancer Center-Oxford — Oxford, Mississippi
• Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi
• Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.