- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658814
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
Study Overview
Status
Conditions
- Acute Myeloid Leukemia
- Secondary Acute Myeloid 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 Without Maturation
- Adult Acute Myelomonocytic Leukemia
- Adult Acute Megakaryoblastic Leukemia
- Adult Erythroleukemia
- Adult Pure Erythroid Leukemia
- Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A
Intervention / Treatment
Detailed Description
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 (QD) 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 (with azacitidine given SC only).
MAINTENANCE THERAPY: Patients receive azacitidine SC 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 (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Palo Alto, California, United States, 94304
- Stanford Cancer Institute Palo Alto
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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Connecticut
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Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Illinois
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Alton, Illinois, United States, 62002
- Saint Anthony's Health
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, United States, 62526
- Heartland Cancer Research NCORP
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Elgin, Illinois, United States, 60123
- Advocate Sherman Hospital
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
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Springfield, Illinois, United States, 62781
- Memorial Medical Center
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Indiana
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Beech Grove, Indiana, United States, 46107
- Franciscan Saint Francis Health-Beech Grove
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Richmond, Indiana, United States, 47374
- Reid Health
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Kansas
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Anthony, Kansas, United States, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, United States, 67905
- Cancer Center of Kansas-Liberal
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Liberal, Kansas, United States, 67901
- Southwest Medical Center
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Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
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Overland Park, Kansas, United States, 66209
- Menorah Medical Center
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Overland Park, Kansas, United States, 66213
- Saint Luke's South Hospital
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Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
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Prairie Village, Kansas, United States, 66208
- Kansas City NCI Community Oncology Research Program
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Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, United States, 67401
- Salina Regional Health Center
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Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
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Shawnee Mission, Kansas, United States, 66204
- Advent Health - Shawnee Mission Medical Center
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, United States, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, United States, 67208
- Associates In Womens Health
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Wichita, Kansas, United States, 67214
- Wichita NCI Community Oncology Research Program
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Wichita, Kansas, United States, 67214
- Wesley Medical Center
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Hematology/Oncology Clinic PLLC
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, United States, 48106
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
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Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
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Big Rapids, Michigan, United States, 49307
- Spectrum Health Big Rapids Hospital
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Dearborn, Michigan, United States, 48124
- Beaumont Hospital - Dearborn
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
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Flint, Michigan, United States, 48532
- Genesys Regional Medical Center-West Flint Campus
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan NCORP
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Grand Rapids, Michigan, United States, 49503
- Trinity Health Grand Rapids Hospital
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Jackson, Michigan, United States, 49201
- Allegiance Health
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Lansing, Michigan, United States, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, United States, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Muskegon, Michigan, United States, 49444
- Trinity Health Muskegon Hospital
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Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Lake Huron Medical Center
-
Saginaw, Michigan, United States, 48601
- Ascension Saint Mary's Hospital
-
Southfield, Michigan, United States, 48075
- Ascension Providence Hospitals - Southfield
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Traverse City, Michigan, United States, 49684
- Munson Medical Center
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Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
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Wyoming, Michigan, United States, 49519
- University of Michigan Health - West
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Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, United States, 63701
- Southeast Missouri Hospital
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Kansas City, Missouri, United States, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, United States, 64111
- Saint Luke'S Hospital of Kansas City
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Kansas City, Missouri, United States, 64132
- Research Medical Center
-
Kansas City, Missouri, United States, 64108
- Truman Medical Centers
-
Kansas City, Missouri, United States, 64118
- Heartland Hematology and Oncology Associates Incorporated
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Kansas City, Missouri, United States, 64114
- Saint Joseph Health Center
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Lee's Summit, Missouri, United States, 64086
- Saint Luke's East - Lee's Summit
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Liberty, Missouri, United States, 64068
- Liberty Radiation Oncology Center
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Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
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Saint Joseph, Missouri, United States, 64507
- Saint Joseph Oncology Inc
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Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, United States, 63109
- Saint Louis Cancer and Breast Institute-South City
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Saint Louis, Missouri, United States, 63141
- Saint Louis-Cape Girardeau CCOP
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Montana
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Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
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Billings, Montana, United States, 59101
- Saint Vincent Healthcare
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Billings, Montana, United States, 59102
- Montana Cancer Consortium NCORP
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, United States, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
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Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, United States, 59405
- Great Falls Clinic
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Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Great Falls, Montana, United States, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, United States, 59501
- Northern Montana Hospital
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Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, United States, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology
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Missoula, Montana, United States, 59804
- Community Medical Hospital
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Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, United States, 59802
- Montana Cancer Specialists
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital
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Hendersonville, North Carolina, United States, 28791
- Margaret R Pardee Memorial Hospital
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Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
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Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research Consortium NCORP
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Ohio
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Akron, Ohio, United States, 44307
- Cleveland Clinic Akron General
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Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
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Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati Cancer Center-UC Medical Center
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, United States, 43228
- Doctors Hospital
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Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, United States, 43215
- Columbus NCI Community Oncology Research Program
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Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45459
- Dayton NCI Community Oncology Research Program
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Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
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Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, United States, 45331
- Wayne Hospital
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Kettering, Ohio, United States, 45429
- Kettering Medical Center
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Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
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Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
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Mount Vernon, Ohio, United States, 43050
- Knox Community Hospital
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Newark, Ohio, United States, 43055
- Licking Memorial Hospital
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Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
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Springfield, Ohio, United States, 45505
- Springfield Regional Medical Center
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Troy, Ohio, United States, 45373
- Upper Valley Medical Center
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Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
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Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, United States, 45385
- Greene Memorial Hospital
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Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
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Oregon
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Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
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Gresham, Oregon, United States, 97030
- Legacy Mount Hood Medical Center
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Milwaukie, Oregon, United States, 97222
- Providence Milwaukie Hospital
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Newberg, Oregon, United States, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, United States, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, United States, 97210
- Legacy Good Samaritan Hospital and Medical Center
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Portland, Oregon, United States, 97213
- Providence Portland Medical Center
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Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
-
Portland, Oregon, United States, 97216
- Adventist Medical Center
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Salem, Oregon, United States, 97301
- Salem Hospital
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Tualatin, Oregon, United States, 97062
- Legacy Meridian Park Hospital
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South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Health Hospital
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
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Texas
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Amarillo, Texas, United States, 79106
- The Don and Sybil Harrington Cancer Center
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Washington
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Anacortes, Washington, United States, 98221
- Cancer Care Center at Island Hospital
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Bellingham, Washington, United States, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, United States, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
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Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
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Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
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Mount Vernon, Washington, United States, 98274
- Skagit Valley Hospital
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Poulsbo, Washington, United States, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Seattle, Washington, United States, 98122
- Swedish Medical Center-First Hill
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Seattle, Washington, United States, 98195
- University of Washington Medical Center - Montlake
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Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
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Seattle, Washington, United States, 98104
- Minor and James Medical PLLC
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Sedro-Woolley, Washington, United States, 98284
- PeaceHealth United General Medical Center
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Spokane, Washington, United States, 99218
- Evergreen Hematology and Oncology PS
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Spokane, Washington, United States, 99202
- Cancer Care Northwest - Spokane South
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Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
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Wenatchee, Washington, United States, 98801
- Wenatchee Valley Hospital and Clinics
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Wyoming
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Casper, Wyoming, United States, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (azacitidine, gemtuzumab)
See Detailed Description
|
Given IV
Other Names:
Given IV or SC during induction; given SC during consolidation and maintenance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response
Time Frame: Up to 60 days
|
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
Time Frame: 30 days
|
Patients surviving more than 30 days after study registration
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Time Frame: Up to 5 years
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 5 years
|
Relapse-free Survival
Time Frame: Up to 5 years
|
Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi.
RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse.
Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sucha Nand, SWOG Cancer Research Network
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia, Myelomonocytic, Acute
- Leukemia, Monocytic, Acute
- Leukemia, Megakaryoblastic, Acute
- Leukemia, Erythroblastic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Immunoconjugates
- Immunotoxins
- Azacitidine
- Gemtuzumab
- Calicheamicins
Other Study ID Numbers
- NCI-2009-00790 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (U.S. NIH Grant/Contract)
- SWOG-S0703
- CDR0000593117
- S0703 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
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Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
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Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
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C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
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National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
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Kronos BioActive, not recruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States, Spain
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Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
Clinical Trials on Gemtuzumab Ozogamicin
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University Hospital HeidelbergTerminated
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University Hospital Carl Gustav CarusUnknownAcute Myeloid Leukemia | Allogeneic TransplantationGermany
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PfizerCompletedLeukemia, Myeloid, AcuteUnited States
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PfizerCompleted
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University of AarhusCompleted
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PfizerCompletedLeukemiaUnited States
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)UnknownMyelodysplastic SyndromesUnited States
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European Organisation for Research and Treatment...Gruppo Italiano Malattie EMatologiche dell'AdultoUnknownLeukemiaBelgium, Italy, Netherlands
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Medical College of WisconsinCompletedRelapsed Adult AMLUnited States
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Versailles HospitalUnknown