Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	SWOG-S0521 S0521, NCT00492856

Special Category: CTSU trial

Objectives

1. Compare disease-free survival in patients with previously untreated low- or intermediate-risk acute promyelocytic leukemia treated with induction and consolidation combination chemotherapy with or without gemtuzumab ozogamicin followed by maintenance therapy comprising tretinoin, mercaptopurine, and methotrexate vs observation.
2. Assess the toxicity of these regimens in these patients.
3. Determine whether gene expression profiling assessed prior to treatment is predictive of resistance to remission induction chemotherapy and correlate with detectable minimal residual disease post-consolidation therapy.
4. Determine the relapse-free survival of patients who respond to induction chemotherapy.
5. Assess, preliminarily, the outcomes of patients who fail to achieve or maintain PCR-negative PML-RARα fusion gene after consolidation therapy when treated with gemtuzumab ozogamicin.

Entry 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 WBC ≤ 10,000/mm³ and platelet count > 40,000/mm³
    • Intermediate-risk disease, defined as WBC ≤ 10,000/mm³ and platelet count ≤ 40,000/mm³
    • 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

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/m²/day allowed provided it was received ≤ 5 days prior to study registration

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

Expected Enrollment

Outcomes

Disease-free survival
Overall survival
Toxicity

Outline

This is a randomized, multicenter study.

• Induction therapy: Patients receive oral tretinoin twice daily until morphologic complete remission (CR) or for a maximum of 90 days in the absence of disease progression or unacceptable toxicity. Patients also receive cytarabine IV continuously on days 3-9 and daunorubicin hydrochloride IV on days 3-6.
• Consolidation therapy: Patients who achieve CR, CR with incomplete blood count recovery (CRi), or partial remission (PR) after induction therapy receive arsenic trioxide IV over 2 hours 5 days a week for 5 weeks. After a 2-week rest period, patients receive a second course of arsenic trioxide. Within 14-30 days after blood count recovery, patients receive oral tretinoin twice daily on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients receive a second course of tretinoin and daunorubicin hydrochloride after adequate blood count recovery.
• Post-consolidation therapy: Patients who do not achieve molecular CR (CRm), but do achieve CR or CRi and are still PML-RARα-positive after consolidation therapy, receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment repeats every 14 days for up to 6 courses or until PML-RARα-negative by PCR. Patients who are in CRm are stratified according to age (18 to 60 years vs > 60 years), acute promyelocytic leukemia (APL) risk group (low vs intermediate), and if the patient received consolidation therapy courses 3 or 4 (yes vs no). These patients are randomized to 1 of 2 treatment arms.
  • Arm I: Beginning 14-30 days after blood count recovery, 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.
  • Arm II: Patients receive no further chemotherapy. Patients are followed every 3 months for 1 year.

Patients undergo blood collection periodically for cytogenetic studies. Samples are analyzed for PML-RARα fusion gene via reverse transcriptase-polymerase chain reaction (RT-PCR) assay and gene expression profiling.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Steven Coutre, MD, Protocol chair		Ph: 650-723-5007 Email: coutre@stanford.edu

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
California
	Roseville
	Sutter Cancer Center at Roseville Medical Center
		Clinical Trials Office - Sutter Cancer Center	Ph:  916-454-6595
	Sacramento
	Sutter Cancer Center
		Clinical Trial Office - Sutter Cancer Center	Ph:  916-454-6595
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Illinois
	Berwyn
	Hematology Oncology Associates of Illinois - Berwyn
		Martin Tallman, MD	Ph:  312-695-0990
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Bloomington%
	Illinois CancerCare - Bloomington
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Canton
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Illinois CancerCare - Carthage
		John Kugler, MD	Ph:  309-243-3605
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	Hematology and Oncology Associates
		Clinical Trails Office - Hematology and Oncology Associates	Ph:  312-695-1301
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Eureka
		John Kugler, MD	Ph:  309-243-3605
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Galesburg
		John Kugler, MD	Ph:  309-243-3605
	Havana
	Illinois CancerCare - Havana
		John Kugler, MD	Ph:  309-243-3605
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Highland Park
	Kellogg Cancer Care Center
		Martin Tallman, MD	Ph:  312-695-0990
	Joliet
	Midwest Center for Hematology/Oncology
		Martin Tallman, MD	Ph:  312-695-0990
	Kewanee
	Illinois CancerCare - Kewanee Clinic
		John Kugler, MD	Ph:  309-243-3605
	Libertyville
	North Shore Oncology and Hematology Associates, Limited - Libertyville
		Martin Tallman, MD	Ph:  312-695-0990
	Macomb
	Illinois CancerCare - Macomb
		John Kugler, MD	Ph:  309-243-3605
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Monmouth
	Illinois CancerCare - Monmouth
		John Kugler, MD	Ph:  309-243-3605
	OSF Holy Family Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Naperville
	La Grange Oncology Associates - Geneva
		Martin Tallman, MD	Ph:  312-695-0990
	Niles
	Cancer Care and Hematology Specialists of Chicagoland - Niles
		Martin Tallman, MD	Ph:  312-695-0990
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Illinois CancerCare - Pekin
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois CancerCare - Peru
		John Kugler, MD	Ph:  309-243-3605
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Illinois CancerCare - Princeton
		John Kugler, MD	Ph:  309-243-3605
	Skokie
	Hematology Oncology Associates - Skokie
		Martin Tallman, MD	Ph:  312-695-0990
	Spring Valley
	Illinois CancerCare - Spring Valley
		John Kugler, MD	Ph:  309-243-3605
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3605
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Anthony
	Hospital District Sixth of Harper County
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Tammy Walker Cancer Center at Salina Regional Health Center
		William Cathcart-Rake, MD	Ph:  785-452-4860
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Daniel DeAngelo	Ph:  617-632-3474 866-790-4500
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Josephine Ford Cancer Center at Henry Ford Hospital
		Robert Chapman, MD	Ph:  313-916-1332
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Lichfield
	Meeker County Memorial Hospital
		Clinical Trials Office - Meeker County Memorial Hospital	Ph:  320-693-4520
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Saint Louis
	Saint Louis University Cancer Center
		Clinical Trials Office - Saint Louis University Cancer Center	Ph:  314-977-4440
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Geoffrey Uy	Ph:  314-747-7222 800-600-3606
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Robert Langdon, MD	Ph:  402-399-8762
New Jersey
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Janice Dutcher	Ph:  718-304-7200
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Lake Success
	Monter Cancer Center of the North Shore-LIJ Health System
		Jonathan Kolitz, MD	Ph:  516-562-8970
	Manhasset
	CCOP - North Shore University Hospital
		Jonathan Kolitz, MD	Ph:  516-562-8970
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	New Hyde Park
	Long Island Jewish Medical Center
		Jonathan Kolitz, MD	Ph:  516-562-8970
	New York
	NYU Cancer Institute at New York University Medical Center
		Bruce Raphael, MD	Ph:  212-731-5185
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Richard Fisher, MD	Ph:  585-275-0842
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Adel Makary, MD	Ph:  570-271-6045
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	State College
	Geisinger Medical Group - Scenery Park
		Adel Makary, MD	Ph:  570-271-6045
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
South Dakota
	Sioux Falls
	Avera Cancer Institute
		Addison Tolentino	Ph:  605-322-3000
	Medical X-Ray Center, PC
		Loren Tschetter, MD	Ph:  605-328-8000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Utah
	American Fork
	American Fork Hospital
		Clyde Ford	Ph:  801-855-3300
	Cedar City
	Sandra L. Maxwell Cancer Center
		Clyde Ford	Ph:  801-585-0550
	Logan
	Logan Regional Hospital
		Clyde Ford	Ph:  435-716-1000
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		Clyde Ford	Ph:  801-507-3800 866-500-1530
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		Clinical Trials Office - McKay-Dee Hospital Center	Ph:  801 387-7426
	Provo
	Utah Valley Regional Medical Center - Provo
		Clinical Trials Office - Utah Valley Regional Medical Center - Provo	Ph:  801-357-7965
	Saint George
	Dixie Regional Medical Center - East Campus
		Clinical Trials Office - Dixie Regional Medical Center - East Campus	Ph:  435-688-4167
	Salt Lake City
	LDS Hospital
		Clyde Ford	Ph:  801-408-1819
		Clyde Ford	Ph:  801-408-1819
	Utah Cancer Specialists at UCS Cancer Center
		Clyde Ford	Ph:  801-269-0231
Washington
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Fred Hutchinson Cancer Research Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Harborview Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Minor and James Medical, PLLC
		Saul Rivkin, MD	Ph:  206-386-2441
	Polyclinic First Hill
		Saul Rivkin, MD	Ph:  206-386-2441
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Wenatchee
	Wenatchee Valley Medical Center
		Clinical Trials Office - Wenatchee Valley Medical Center	Ph:  509-665-5800
West Virginia
	Morgantown
	Mary Babb Randolph Cancer Center at West Virginia University Hospitals
		Michael Craig	Ph:  304-293-4500 877-427-2894
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Clinical Trials Office - Froedtert Hospital	Ph:  414-805-3666
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Related Information

PDQ® clinical trial SWOG-S9910
PDQ® clinical trial SWOG-9007

Registry Information
Official Title		A Randomized Trial of Maintenance Versus Observation for Patients With Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
Trial Start Date		2007-06-01
Trial Completion Date		2012-09-01 (estimated)
Registered in ClinicalTrials.gov		NCT00492856
Date Submitted to PDQ		2007-05-25
Information Last Verified		2009-11-18
NCI Grant/Contract Number		CA32102

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