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ACTIVE NOT RECRUITING

NCT00658814

PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

133

Start Date

2008-12-01

Completion Date

2026-03-19

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Interventions

DRUG

Azacitidine

Given IV or SC during induction; given SC during consolidation and maintenance

DRUG

Gemtuzumab Ozogamicin

Given IV

Inclusion Criteria: * 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 * No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base * Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration * Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) \>= 1,000/mcL and platelets \>= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration * Patients must have serum creatinine =\< 1.5 x IULN and SGOT or SGPT =\< 1.5 x IULN within 28 days before registration * Patients must have recovered to =\< Grade 2 from any induction cycle non-hematologic toxicities

Locations (177)

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

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

Menorah Medical Center

Overland Park, Kansas, United States

Saint Luke's South Hospital

Overland Park, Kansas, United States

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

AdventHealth Shawnee Mission

Shawnee Mission, Kansas, United States

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Hematology/Oncology Clinic PLLC

Baton Rouge, Louisiana, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, United States

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Lake Huron Medical Center

Port Huron, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Southeast Missouri Hospital

Cape Girardeau, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

University Health Truman Medical Center