Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
- Conditions
- Leukemia
- Registration Number
- NCT00070174
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
Primary
* Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.
* Determine the complete remission rate of patients treated with this regimen.
Secondary
* Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.
* Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
* Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II.
* Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I.
* Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II.
* Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III.
* Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.
* Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0.
* Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11.
In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Complete remission rate
- Secondary Outcome Measures
Name Time Method Feasibility Effect of karyotypic abnormalities
Trial Locations
- Locations (148)
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital and Research Center - Oakland
🇺🇸Oakland, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Hartford, Connecticut, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Spectrum Health Cancer Care - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸East Lansing, Michigan, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Medical College of Ohio Cancer Institute
🇺🇸Toledo, Ohio, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Children's Hospitals and Clinics - Minneapolis/St. Paul
🇺🇸Minneapolis, Minnesota, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Point Woods, Michigan, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Carilion Cancer Center of Western Virginia
🇺🇸Roanoke, Virginia, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
🇺🇸Tacoma, Washington, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital Cancer Center
🇺🇸Denver, Colorado, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Ste-Foy, Quebec, Canada
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Hospital of Omaha
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
Cardinal Glennon Children's Hospital
🇺🇸St. Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Office of S. David Lang
🇦🇺Herston, Brisbane, Queensland, Australia
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Ft. Myers, Florida, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Broward General Medical Center Cancer Center
🇺🇸Ft. Lauderdale, Florida, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Chihuahua, Switzerland
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
M.D. Anderson Cancer Center - Orlando
🇺🇸Orlando, Florida, United States
C.S. Mott Children's Hospital at University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States