Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
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
5 other identifiers
interventional
133
1 country
177
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Longer than P75 for phase_2
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedResults Posted
Study results publicly available
January 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedApril 30, 2026
December 1, 2025
4.5 years
April 12, 2008
July 22, 2013
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Complete Response
Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Up to 60 days
30-Day Survival
Patients surviving more than 30 days after study registration
30 days
Secondary Outcomes (2)
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Up to 5 years
Relapse-free Survival
Up to 5 years
Study Arms (1)
Treatment (azacitidine, gemtuzumab)
EXPERIMENTALSee Detailed Description
Interventions
Given IV or SC during induction; given SC during consolidation and maintenance
Given IV
Eligibility Criteria
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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (177)
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Reid Health
Richmond, Indiana, 47374, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, 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-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, 66204, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
University Health Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Community Medical Center
Missoula, Montana, 59804, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
University of Rochester
Rochester, New York, 14642, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227, United States
Salem Hospital
Salem, Oregon, 97301, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Nand S, Othus M, Godwin JE, Willman CL, Norwood TH, Howard DS, Coutre SE, Erba HP, Appelbaum FR. A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia. Blood. 2013 Nov 14;122(20):3432-9. doi: 10.1182/blood-2013-06-506592. Epub 2013 Oct 3.
PMID: 24092933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG
Study Officials
- PRINCIPAL INVESTIGATOR
Sucha Nand
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2008
First Posted
April 15, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2013
Study Completion (Estimated)
March 31, 2027
Last Updated
April 30, 2026
Results First Posted
January 6, 2014
Record last verified: 2025-12