New combo therapy shows promise for older leukemia patients

NCT ID NCT00658814

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tested a combination of two drugs, azacitidine and gemtuzumab ozogamicin, in 133 older adults (age 60+) with untreated acute myeloid leukemia. The goal was to see how well the treatment could put the cancer into remission and improve survival. The approach uses chemotherapy plus a targeted antibody to kill cancer cells more effectively.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

133 people

The number who actually took part.

Started

Dec 2008

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute erythroid leukemia acute megakaryoblastic leukemia acute megakaryoblastic leukemia in adult acute monocytic leukemia acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myeloid leukemia, t(8;21)(q22; q22.1) acute myelomonocytic leukemia M4 adult acute monocytic leukemia Leukemia, Myelomonocytic, Acute therapy related acute myeloid leukemia and myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

Locations

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States
AdventHealth Shawnee Mission

Shawnee Mission, Kansas, 66204, United States
Adventist Medical Center

Portland, Oregon, 97216, United States
Advocate Sherman Hospital

Elgin, Illinois, 60123, United States
Allegiance Health

Jackson, Michigan, 49201, United States
AnMed Health Hospital

Anderson, South Carolina, 29621, United States
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
Associates In Womens Health

Wichita, Kansas, 67208, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Blanchard Valley Hospital

Findlay, Ohio, 45840, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States
Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States
Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States
Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States
Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States
Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States
Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States
Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States
Cleveland Clinic Akron General

Akron, Ohio, 44307, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

Wilmington, Ohio, 45177, United States
Columbus NCI Community Oncology Research Program

Columbus, Ohio, 43215, United States
Community Medical Center

Missoula, Montana, 59804, United States
Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, 66606, United States
Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Doctors Hospital

Columbus, Ohio, 43228, United States
Evergreen Hematology and Oncology PS

Spokane, Washington, 99218, United States
Fairfield Medical Center

Lancaster, Ohio, 43130, United States
Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States
Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States
Glacier Oncology PLLC

Kalispell, Montana, 59901, United States
Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States
Grady Memorial Hospital

Delaware, Ohio, 43015, United States
Grandview Hospital

Dayton, Ohio, 45405, United States
Grant Medical Center

Columbus, Ohio, 43215, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Greene Memorial Hospital

Xenia, Ohio, 45385, United States
Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, 98370, United States
Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States
Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States
Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States
Hematology/Oncology Clinic PLLC

Baton Rouge, Louisiana, 70809, United States
Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States
Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States
Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States
Highline Medical Center-Main Campus

Burien, Washington, 98166, United States
Hospital District Sixth of Harper County

Anthony, Kansas, 67003, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States
Kaiser Permanente Washington

Seattle, Washington, 98112, United States
Kalispell Medical Oncology

Kalispell, Montana, 59901, United States
Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
Knox Community Hospital

Mount Vernon, Ohio, 43050, United States
Lake Huron Medical Center

Port Huron, Michigan, 48060, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States
Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States
Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States
Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States
Liberty Hospital

Liberty, Missouri, 64068, United States
Licking Memorial Hospital

Newark, Ohio, 43055, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States
Marietta Memorial Hospital

Marietta, Ohio, 45750, United States
Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Menorah Medical Center

Overland Park, Kansas, 66209, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States
Minor and James Medical PLLC

Seattle, Washington, 98104, United States
Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States
Montana Cancer Specialists

Missoula, Montana, 59802, United States
Mount Carmel Health Center West

Columbus, Ohio, 43222, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States
North Kansas City Hospital

Kansas City, Missouri, 64116, United States
Northern Montana Hospital

Havre, Montana, 59501, United States
Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States
PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States
PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States
PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States
Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center

Newberg, Oregon, 97132, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States
Reid Health

Richmond, Indiana, 47374, United States
Research Medical Center

Kansas City, Missouri, 64132, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Rocky Mountain Oncology

Casper, Wyoming, 82609, United States
Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States
SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Ann's Hospital

Westerville, Ohio, 43081, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States
Saint Joseph Health Center

Kansas City, Missouri, 64114, United States
Saint Joseph Medical Center Hematology and Oncology - Silverdale

Silverdale, Washington, 98383, United States
Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States
Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States
Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States
Saint Peter's Community Hospital

Helena, Montana, 59601, United States
Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
Saint Vincent Healthcare

Billings, Montana, 59101, United States
Salem Hospital

Salem, Oregon, 97301, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States
Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States
Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, 27104, United States
Southeast Missouri Hospital

Cape Girardeau, Missouri, 63701, United States
Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States
Southwest Medical Center

Liberal, Kansas, 67901, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
Springfield Regional Medical Center

Springfield, Ohio, 45504, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States
Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Rochester

Rochester, New York, 14642, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
Wayne Hospital

Greenville, Ohio, 45331, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Welch Cancer Center

Sheridan, Wyoming, 82801, United States
Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States
Wesley Medical Center

Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

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