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.
PRIMARY OBJECTIVES:
I. To test whether outcomes of patients of age 60 or older with previously untreated non-M3
acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to
warrant phase III investigation.
II. To estimate the frequency and severity of toxicities of this regimen in the good- and
poor-risk groups of patients.
III. To investigate in a preliminary manner the disease-free survival of patients who
achieve complete remission and receive post-remission therapy on this study.
IV. To investigate in a preliminary manner the cytogenetic response rates of patients
treated with this regimen.
V. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter
and global methylation changes, and multidrug resistance on overall survival and response to
azacitidine plus gemtuzumab ozogamicin therapy.
OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR
Zubrod performance status [PS] 0-1] vs poor [≥ 70 years of age AND Zubrod PS 2-3]).
REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40
minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2
hours on day 8. Patients with residual leukemia (blast count ≥ 5%) receive a second course
of induction therapy beginning between days 15-29. Patients achieving complete remission
(CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to
receive consolidation therapy.
CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin
as in induction therapy.
MAINTENANCE THERAPY: Patients receive azacitidine IV over 10-40 minutes or subcutaneously on
days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic
studies at baseline, remission, and relapse or progression. Marrow and blood samples are
submitted to correlatives studies and submitted to SWOG ALL/CLL/CML Repository in Seattle,
WA.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3
months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of achieving CR or CRp
30 days
No
Sucha Nand
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2009-00790
NCT00658814
December 2008
Name | Location |
---|---|
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Akron General Medical Center | Akron, Ohio 44302 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Wesley Medical Center | Wichita, Kansas 67214 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Grandview Hospital | Dayton, Ohio 45405 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Memorial Medical Center | Springfield, Illinois 62781 |
University of Rochester | Rochester, New York 14642 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Wayne State University | Detroit, Michigan 48202 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Columbus CCOP | Columbus, Ohio 43206 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Providence Hospital | Southfield, Michigan 48075 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Providence Newberg Medical Center | Newberg, Oregon 97132 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Providence Saint Vincent Medical Center | Portland, Oregon 97225 |
Columbia River Oncology Program | Portland, Oregon 97225 |
The Don and Sybil Harrington Cancer Center | Amarillo, Texas 79106 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Hematology and Oncology Clinic | Baton Rouge, Louisiana 70809 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Stanford University Hospitals and Clinics | Stanford, California 94305 |
Swedish Cancer Institute-Issaquah | Issaquah, Washington 98029 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
PeaceHealth Southwest Medical Center | Vancouver, Washington 98664 |
Providence Willamette Falls Medical Center | Oregon City, Oregon 97045 |