S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute promyelocytic leukemia (M3), untreated adult acute myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS:
Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL
- Previously untreated disease
Low- or intermediate-risk disease
- Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm^3 and platelet count > 40,000/mm^3
- Intermediate-risk disease, defined as WBC ≤ 10,000/mm^3 and platelet count ≤ 40,000/mm^3
- WBC and platelet count confirming low- or intermediate-risk disease must be obtained within 48 hours prior to study registration unless the patient received tretinoin therapy prior to study registration in which case the WBC and platelet count must be obtained within 48 hours prior to study therapy
- PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
- No recurrent disease
Must be registered on clinical trials SWOG-9007 and SWOG-S9910
- Specimens must be collected prior to tretinoin therapy and may be collected after tretinoin therapy
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-3
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 month prior to, during, and for 2 months after completion of study treatment
- No unstable cardiac arrhythmia or unstable angina
No other malignancy within the past 5 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Adequately treated stage I or II cancer (except for highly aggressive malignancies with a high rate of early relapse) currently in complete remission
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia
- Prior tretinoin at a dose of ≤ 45 mg/m^2/day allowed provided it was received ≤ 5 days prior to study registration
Sites / Locations
- Mayo Clinic Scottsdale
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- Stanford Cancer Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Hematology Oncology Associates of Illinois - Berwyn
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- University of Chicago Cancer Research Center
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Kellogg Cancer Care Center
- Midwest Center for Hematology/Oncology
- Illinois CancerCare - Kewanee Clinic
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Illinois CancerCare - Monmouth
- La Grange Oncology Associates - Geneva
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Hematology Oncology Associates - Skokie
- Illinois CancerCare - Spring Valley
- Regional Cancer Center at Memorial Medical Center
- Fort Wayne Medical Oncology and Hematology
- McFarland Clinic, PC
- Medical Oncology and Hematology Associates - West Des Moines
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- 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
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- 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
- Tulane Cancer Center Office of Clinical Research
- CancerCare of Maine at Eastern Maine Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Program at Union Hospital
- Massachusetts General Hospital
- 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
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- 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 Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. 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
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Methodist Estabrook Cancer Center
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Cancer Institute of New Jersey at Cooper - Voorhees
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Roswell Park Cancer Institute
- CCOP - Hematology-Oncology Associates of Central New York
- 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
- NYU Cancer Institute at New York University Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Wayne Memorial Hospital, Incorporated
- Kinston Medical Specialists
- Wake Forest University Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Cleveland Clinic Taussig Cancer Center
- 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
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Hollings Cancer Center at Medical University of South Carolina
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- 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
- 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
- Froedtert Hospital and Medical College of Wisconsin
- Medical College of Wisconsin Cancer Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Post-consolidation therapy arm I
Post-consolidation therapy arm II
Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.
Patients receive no further chemotherapy. Patients are followed every 3 months for 1 year. (Randomization and observation arm closed as of 8/15/10)