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

Running, not enrolling · Phase 2

Conditions studied: Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Secondary Acute Myeloid Leukemia

In brief

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Key facts

Study ID

NCT00658814

Run by

National Cancer Institute (NCI)

People needed

133

Starts

2008-12-01

Expected to finish

2027-03-31

Last updated by the study team

2026-07-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Zubrod performance status 0-3
• No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin
• 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
• Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:
• No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
• Prior cytarabine allowed if dose < 100 mg/m\^2/day
• Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed
• No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin
• At least 30 days since prior therapy for MDS and recovered
• 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
• Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed
• Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML
• Serum creatinine =< 1.5 x IULN
• Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days
• Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory
• Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking
• No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture
• Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method
• Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration
• HIV-positive patients must meet the following criteria:
• No history of acquired immunodeficiency syndrome (AIDS)-defining events
• CD4 cells >= 500/mm\^3
• Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on cART or < 25,000 copies HIV mRNA if not on cART
• No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study

Where it is running

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

Full record on ClinicalTrials.gov

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