Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT00658814)

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. Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
2. Zubrod performance status 0-3
3. No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin
4. No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted
5. Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:
6. No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
7. Prior cytarabine allowed if dose \< 100 mg/m\^2/day
8. Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed
9. No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin
10. At least 30 days since prior therapy for MDS and recovered
11. Bilirubin =\< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML
12. Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed

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

📍 All Participating Trial Locations (177 Sites)

• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Stanford Cancer Institute Palo Alto — Palo Alto, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
• OSF Saint Anthony's Health Center — Alton, Illinois
• Decatur Memorial Hospital — Decatur, Illinois
• Heartland Cancer Research NCORP — Decatur, Illinois
• Advocate Sherman Hospital — Elgin, Illinois
• Loyola University Medical Center — Maywood, Illinois
• SSM Health Good Samaritan — Mount Vernon, Illinois
• Springfield Memorial Hospital — Springfield, Illinois
• Franciscan Saint Francis Health-Beech Grove — Beech Grove, Indiana
• Reid Health — Richmond, Indiana
• Hospital District Sixth of Harper County — Anthony, Kansas
• Cancer Center of Kansas - Chanute — Chanute, Kansas
• Cancer Center of Kansas - Dodge City — Dodge City, Kansas
• Cancer Center of Kansas - El Dorado — El Dorado, Kansas
• Cancer Center of Kansas - Fort Scott — Fort Scott, Kansas
• Cancer Center of Kansas-Independence — Independence, Kansas
• Cancer Center of Kansas-Kingman — Kingman, Kansas
• Lawrence Memorial Hospital — Lawrence, Kansas
• Southwest Medical Center — Liberal, Kansas
• Cancer Center of Kansas-Liberal — Liberal, Kansas
• Cancer Center of Kansas - Newton — Newton, Kansas

💰 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.