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Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
asparaginase
busulfan
cyclophosphamide
cyclosporine
cytarabine
daunorubicin hydrochloride
etoposide
gemtuzumab ozogamicin
methotrexate
mitoxantrone hydrochloride
allogeneic bone marrow transplantation
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute monocytic leukemia (M5b), childhood acute megakaryocytic leukemia (M7), childhood acute minimally differentiated myeloid leukemia (M0), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myelomonocytic leukemia (M4), childhood acute monoblastic leukemia (M5a), childhood acute erythroleukemia (M6)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Newly diagnosed primary acute myeloid leukemia (AML) At least 20% bone marrow blasts Meets the customary FAB criteria for AML Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above Previously untreated disease No promyelocytic leukemia (FAB M3) No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts) No juvenile myelomonocytic leukemia No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome No Down syndrome PATIENT CHARACTERISTICS: Age 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed Performance status Karnofsky 50-100% (over 16 years of age) OR Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status Life expectancy Not specified Hematopoietic Not specified Hepatic No inadequate liver function Renal No inadequate renal function No hyperuricemia (greater than 8.0 mg/dL) Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR Creatinine no greater than 1.5 times normal Cardiovascular Shortening fraction at least 27% by echocardiogram OR Ejection fraction at least 50% by MUGA Pulmonary No proven or suspected pneumonia Other Not pregnant or nursing No proven or suspected sepsis or meningitis PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis Endocrine therapy Prior topical and inhalation steroids allowed No concurrent steroids as antiemetics Radiotherapy No prior radiotherapy Surgery Not specified Other No prior antileukemic therapy No concurrent pressor agent or ventilatory support unless approved by the study chair No concurrent participation in another COG therapeutic study

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Phoenix Children's Hospital
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Children's Hospital Los Angeles
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Children's Hospital Central California
  • Children's Hospital and Research Center - Oakland
  • Children's Hospital of Orange County
  • University of California Davis Cancer Center
  • Sutter Cancer Center
  • Kaiser Permanente Medical Center - Oakland
  • Children's Hospital and Health Center - San Diego
  • Children's Hospital Cancer Center
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  • Alfred I. duPont Hospital for Children
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • Broward General Medical Center Cancer Center
  • Lee Cancer Care of Lee Memorial Health System
  • University of Florida Shands Cancer Center
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Nemours Children's Clinic
  • University of Miami Sylvester Comprehensive Cancer Center
  • Miami Children's Hospital
  • Baptist-South Miami Regional Cancer Program
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
  • M.D. Anderson Cancer Center - Orlando
  • Sacred Heart Cancer Center at Sacred Heart Hospital
  • All Children's Hospital
  • St. Joseph's Cancer Institute at St. Joseph's Hospital
  • Kaplan Cancer Center at St. Mary's Medical Center
  • Emory University Hospital - Atlanta
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Cancer Research Center of Hawaii
  • St. Luke's Mountain States Tumor Institute - Boise
  • Children's Memorial Hospital - Chicago
  • University of Chicago Cancer Research Center
  • Lutheran General Cancer Care Center
  • Southern Illinois University School of Medicine
  • Indiana University Cancer Center
  • St. Vincent Indianapolis Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Wesley Medical Center
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Kosair Children's Hospital
  • CancerCare of Maine at Eastern Maine Medial Center
  • Maine Children's Cancer Program
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Floating Hospital for Children
  • C.S. Mott Children's Hospital at University of Michigan
  • Barbara Ann Karmanos Cancer Institute
  • Breslin Cancer Center at Ingham Regional Medical Center
  • Spectrum Health Cancer Care - Butterworth Campus
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • CCOP - Kalamazoo
  • Children's Hospitals and Clinics - Minneapolis/St. Paul
  • Fairview University Medical Center - University Campus
  • Mayo Clinic Cancer Center
  • University of Mississippi Medical Center
  • Keesler Medical Center - Keesler Air Force Base
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Children's Hospital of Omaha
  • Sunrise Hospital and Medical Center
  • Hackensack University Medical Center
  • St. Barnabas Medical Center
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Newark Beth Israel Medical Center
  • St. Joseph's Hospital and Medical Center
  • University of New Mexico Cancer Research and Treatment Center
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • Brooklyn Hospital Center
  • Maimonides Medical Center
  • Roswell Park Cancer Institute
  • Winthrop University Hospital
  • Schneider Children's Hospital
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • Mission Hospitals - Memorial Campus
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • CCOP - MeritCare Hospital
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Columbus Children's Hospital
  • Children's Medical Center - Dayton
  • Toledo Hospital
  • Medical College of Ohio Cancer Institute
  • Oklahoma University Medical Center
  • Cancer Institute at Oregon Health and Science University
  • Geisinger Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Hollings Cancer Center at Medical University of South Carolina
  • Palmetto Health South Carolina Cancer Center
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Vanderbilt-Ingram Cancer Center
  • Texas Tech University Health Sciences Center School of Medicine
  • Children's Hospital of Austin
  • Driscoll Children's Hospital
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Covenant Children's Hospital
  • University of Texas Health Science Center at San Antonio
  • Methodist Children's Hospital of South Texas
  • CCOP - Scott and White Hospital
  • Primary Children's Medical Center
  • Fletcher Allen Health Care - University Health Center Campus
  • INOVA Fairfax Hospital
  • Massey Cancer Center at Virginia Commonwealth University
  • Carilion Cancer Center of Western Virginia
  • Children's Hospital and Regional Medical Center - Seattle
  • Providence Cancer Center at Sacred Heart Medical Center
  • Mary Bridge Children's Hospital and Health Center - Tacoma
  • Madigan Army Medical Center
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Cabell Huntington Hospital
  • St. Vincent Hospital
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Midwest Children's Cancer Center
  • Westmead Hospital
  • Office of S. David Lang
  • Princess Margaret Hospital for Children
  • Alberta Children's Hospital
  • Children's & Women's Hospital of British Columbia
  • CancerCare Manitoba
  • Janeway Children's Health and Rehabilitation Centre
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • McGill Cancer Centre at McGill University
  • Hopital Sainte Justine
  • Centre Hospitalier Universitaire de Quebec
  • San Jorge Children's Hospital
  • Swiss Pediatric Oncology Group Bern

Outcomes

Primary Outcome Measures

Safety
Complete remission rate

Secondary Outcome Measures

Feasibility
Effect of karyotypic abnormalities

Full Information

First Posted
October 3, 2003
Last Updated
February 19, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00070174
Brief Title
Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
Official Title
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute monocytic leukemia (M5b), childhood acute megakaryocytic leukemia (M7), childhood acute minimally differentiated myeloid leukemia (M0), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myelomonocytic leukemia (M4), childhood acute monoblastic leukemia (M5a), childhood acute erythroleukemia (M6)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
gemtuzumab ozogamicin
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Primary Outcome Measure Information:
Title
Safety
Title
Complete remission rate
Secondary Outcome Measure Information:
Title
Feasibility
Title
Effect of karyotypic abnormalities

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed primary acute myeloid leukemia (AML) At least 20% bone marrow blasts Meets the customary FAB criteria for AML Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above Previously untreated disease No promyelocytic leukemia (FAB M3) No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts) No juvenile myelomonocytic leukemia No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome No Down syndrome PATIENT CHARACTERISTICS: Age 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed Performance status Karnofsky 50-100% (over 16 years of age) OR Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status Life expectancy Not specified Hematopoietic Not specified Hepatic No inadequate liver function Renal No inadequate renal function No hyperuricemia (greater than 8.0 mg/dL) Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR Creatinine no greater than 1.5 times normal Cardiovascular Shortening fraction at least 27% by echocardiogram OR Ejection fraction at least 50% by MUGA Pulmonary No proven or suspected pneumonia Other Not pregnant or nursing No proven or suspected sepsis or meningitis PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis Endocrine therapy Prior topical and inhalation steroids allowed No concurrent steroids as antiemetics Radiotherapy No prior radiotherapy Surgery Not specified Other No prior antileukemic therapy No concurrent pressor agent or ventilatory support unless approved by the study chair No concurrent participation in another COG therapeutic study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Franklin, MD, MPH
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354-2870
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-1865
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital and Research Center - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Children's Hospital and Health Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
Children's Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Broward General Medical Center Cancer Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
M.D. Anderson Cancer Center - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404-6283
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
95813
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6297
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1463
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9230
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1083
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1822
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medial Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-5001
Country
United States
Facility Name
Floating Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0238
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824-1313
Country
United States
Facility Name
Spectrum Health Cancer Care - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Point Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5341
Country
United States
Facility Name
Children's Hospitals and Clinics - Minneapolis/St. Paul
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Fairview University Medical Center - University Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0392
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Keesler Medical Center - Keesler Air Force Base
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2511
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4113
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112-2094
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5493
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032-1537
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801-4690
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1081
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5217
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Medical College of Ohio Cancer Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1320
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2583
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203-6897
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Children's Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411-1721
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0121
Country
United States
Facility Name
Carilion Cancer Center of Western Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24029
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
Mary Bridge Children's Hospital and Health Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601-5429
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Office of S. David Lang
City
Herston, Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Children's Health and Rehabilitation Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
State/Province
Chihuahua
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
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Pollard JA, Alonzo TA, Gerbing RB, Ho PA, Zeng R, Ravindranath Y, Dahl G, Lacayo NJ, Becton D, Chang M, Weinstein HJ, Hirsch B, Raimondi SC, Heerema NA, Woods WG, Lange BJ, Hurwitz C, Arceci RJ, Radich JP, Bernstein ID, Heinrich MC, Meshinchi S. Prevalence and prognostic significance of KIT mutations in pediatric patients with core binding factor AML enrolled on serial pediatric cooperative trials for de novo AML. Blood. 2010 Mar 25;115(12):2372-9. doi: 10.1182/blood-2009-09-241075. Epub 2010 Jan 7.
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Berman JN, Gerbing RB, Alonzo TA, Ho PA, Miller K, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Gamis A, Meshinchi S. Prevalence and clinical implications of NRAS mutations in childhood AML: a report from the Children's Oncology Group. Leukemia. 2011 Jun;25(6):1039-42. doi: 10.1038/leu.2011.31. Epub 2011 Mar 1. No abstract available.
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Sung L, Alonzo TA, Gerbing RB, Aplenc R, Lange BJ, Woods WG, Feusner J, Franklin J, Patterson MJ, Gamis AS; Children's Oncology Group. Respiratory syncytial virus infections in children with acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Dec;51(6):784-6. doi: 10.1002/pbc.21710.
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derived

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Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

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