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

Alternate Title

Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin Followed By High-Dose Cytarabine Followed By Either Gemtuzumab Ozogamicin or No Additional Therapy in Treating Patients With Previously Untreated De Novo Acute Myeloid Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 to 60 NCI SWOG-S0106 S0106, NCT00085709

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy.
2. Compare the complete remission rate in patients treated with these regimens.
3. Compare the frequency and severity of the toxic effects of these regimens in these patients.
4. Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin.
5. Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens.
6. Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens.
7. Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy* within the past 14 days
  • No M3 disease

   [Note: *Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL]




• No blastic transformation of chronic myelogenous leukemia



• No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy
  • Prior hydroxyurea to control high cell counts allowed
• No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
• Concurrent intrathecal chemotherapy allowed during induction therapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 18 to 60

Performance status

• Zubrod 0-3

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• No known hepatitis B or C infection
• No known liver disease

Renal

• Not specified

Cardiovascular

• LVEF ≥ 50% by MUGA or echocardiogram
• No unstable cardiac arrhythmias
• No unstable angina

Other

• 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 II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 684 patients (342 per treatment arm) will be accrued for this study within 4.5-5 years.

Outcomes

Disease-free survival
Induction complete remission rate

Outline

This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group.

• Induction therapy: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover.
  
  
  
  • Arm II: Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I.
  
  
  

  Patients in both arms undergo bone marrow aspiration and biopsy on day 14 (and on day 19, if applicable) and then proceed to reinduction therapy.




• Reinduction therapy: Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive G-CSF or GM-CSF as in induction therapy.

  Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy.




• Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

  Patients who maintain A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy.




• Post-consolidation therapy: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  
  
  
  • Arm II: Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.
  
  
  

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

Stephen Petersdorf, MD, Study coordinator		Ph: 206-288-2036

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		Clinical Trials Office - Providence Cancer Center	Ph:  907-261-3109
Arkansas
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700 800-333-1305
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
Colorado
	Colorado Springs
	Memorial Hospital Cancer Center - Colorado Springs
		Clinical Trials Office - Memorial Hospital	Ph:  719-365-2406
Georgia
	Macon
	Medical Center of Central Georgia
		Frederick Schnell, MD, FACP	Ph:  478-743-7068
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3000
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Chicago
	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:  309-243-3000
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3000
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3000
	InterCommunity Cancer Center of Western Illinois
		John Kugler, MD	Ph:  309-243-3000
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3000
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3010
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3000
	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:  309-243-3000
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3000
	Valley Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Davenport
	Genesis Medical Center - West Campus
		George Kovach, MD	Ph:  563-421-1960
	Genesis Regional Cancer Center at Genesis Medical Center
		George Kovach, MD	Ph:  563-421-1960
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	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
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Capitol Hospital
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
Kansas
	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
	Kansas City
	Providence Medical Center
		Rakesh Gaur, MD	Ph:  913-596-4000
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Rakesh Gaur, MD	Ph:  785-840-2800
	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
	Overland Park
	Johnson County Radiation Therapy
		Rakesh Gaur, MD	Ph:  913-469-0002
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  913-498-6000
	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:  785-827-7261
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  913-676-2000
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	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
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Robert Veith	Ph:  225-767-0847
	Pennington Cancer Center at Baton Rouge General
		Clinical Trials Office - Pennington Cancer Center at Baton Rouge General	Ph:  225-381-6451
	New Orleans
	MBCCOP - LSU Health Sciences Center
		Robert Veith	Ph:  504-568-5151
	Medical Center of Louisiana - New Orleans
		Robert Veith	Ph:  504-903-2311
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
	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
		Clinical Trials Office - Dana-Farber/Harvard Cancer Center	Ph:  617-582-8480
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center