S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), untreated adult acute myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS:
Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination
- APL-RARα-negative by RT-PCR are not eligible
- High-risk disease, defined as WBC > 100,000/mm^3
- Bone marrow specimens must be made available for cytogenetic studies
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prolonged QTc > 0.47 sec
- No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for acute leukemia
- At least 3 days since prior tretinoin (ATRA) allowed
- Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
Sites / Locations
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- Stanford Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- M.D. Anderson Cancer Center at Orlando
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- University of Chicago Cancer Research Center
- Kellogg Cancer Care Center
- Provena St. Mary's Regional Cancer Center - Kankakee
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- Fort Wayne Medical Oncology and Hematology
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Providence Medical Center
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - McPherson
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- CCOP - Kansas City
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greenebaum Cancer Center at University of Maryland Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital of Cecil County
- Massachusetts General Hospital
- Dana-Farber/Brigham and Women's Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Green Bay Oncology, Limited - Escanaba
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Mercy General Health Partners
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Spectrum Health Reed City Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Munson Medical Center
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- University of Mississippi Cancer Clinic
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- North Kansas City Hospital
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Parvin Radiation Oncology
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- Saint Louis University Cancer Center
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Monter Cancer Center of the North Shore-LIJ Health System
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Long Island Jewish Medical Center
- SUNY Upstate Medical University Hospital
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Wayne Memorial Hospital, Incorporated
- Kinston Medical Specialists
- Rutherford Hospital
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- St. Rita's Medical Center
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- Bon Secours St. Francis Health System
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Swedish Medical Center - Issaquah Campus
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Harrison Poulsbo Hematology and Onocology
- Harborview Medical Center
- Minor and James Medical, PLLC
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Wenatchee Valley Medical Center
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- St. Nicholas Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Experimental
Treatment
Induction: ATRA 45mg/m2 PO D1-CR Gemtuzumab Ozogamicin 9 mg/m2 IV D1 Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7 Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days 6-MP 60 mg/m2/d PO daily for 1 year Methotrexate 20 mg/m2 PO once/wk for 1 year