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

February 19, 2014 updated by: Children's Oncology Group

Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Brisbane, Queensland, Australia, 4029
        • Office of S. David Lang
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill Cancer Centre at McGill University
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Children's Hospital
  • Switzerland
    • Chihuahua
      • Bern, Chihuahua, Switzerland, 3010
        • Swiss Pediatric Oncology Group Bern
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242-2814
        • Southern California Permanente Medical Group
      • Loma Linda, California, United States, 92354-2870
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, United States, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90048-1865
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, United States, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, United States, 94609-1809
        • Children's Hospital and Research Center - Oakland
      • Orange, California, United States, 92668
        • Children's Hospital of Orange County
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Oakland
      • Sacramento, California, United States, 95819
        • Sutter Cancer Center
      • San Diego, California, United States, 92123-4282
        • Children's Hospital and Health Center - San Diego
    • Colorado
      • Denver, Colorado, United States, 80218-1088
        • Children's Hospital Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. duPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20007-2197
        • Lombardi Cancer Center at Georgetown University Medical Center
    • Florida
      • Ft. Lauderdale, Florida, United States, 33316
        • Broward General Medical Center Cancer Center
      • Ft. Myers, Florida, United States, 33908
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Miami, Florida, United States, 33176
        • Baptist-South Miami Regional Cancer Program
      • Miami, Florida, United States, 33101
        • University of Miami Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center - Orlando
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Savannah, Georgia, United States, 31404-6283
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 95813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, United States, 83712-6297
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital - Chicago
      • Chicago, Illinois, United States, 60637-1463
        • University of Chicago Cancer Research Center
      • Park Ridge, Illinois, United States, 60068-1174
        • Lutheran General Cancer Care Center
      • Springfield, Illinois, United States, 62794-9230
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
      • Indianapolis, Indiana, United States, 46202-5225
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242-1083
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202-1822
        • Kosair Children's Hospital
    • Maine
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
      • Scarborough, Maine, United States, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, United States, 21287-5001
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Floating Hospital for Children
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0238
        • C.S. Mott Children's Hospital at University of Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • East Lansing, Michigan, United States, 48824-1313
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Grand Rapids, Michigan, United States, 49503-2560
        • Spectrum Health Cancer Care - Butterworth Campus
      • Grosse Point Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, United States, 49007-5341
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics - Minneapolis/St. Paul
      • Minneapolis, Minnesota, United States, 55455-0392
        • Fairview University Medical Center - University Campus
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, United States, 39534-2511
        • Keesler Medical Center - Keesler Air Force Base
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4113
        • Children's Hospital of Omaha
    • Nevada
      • Las Vegas, Nevada, United States, 89109-2306
        • Sunrise Hospital and Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, United States, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Bronx, New York, United States, 10467
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11201-5493
        • Brooklyn Hospital Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hospital
      • New York, New York, United States, 10032-1537
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, United States, 28801-4690
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Charlotte, North Carolina, United States, 28232
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Greenville, North Carolina, United States, 27834
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157-1081
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Cleveland, Ohio, United States, 44195-5217
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Children's Medical Center - Dayton
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43608
        • Medical College of Ohio Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104-9786
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, United States, 15213-2583
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, United States, 29203-6897
        • Palmetto Health South Carolina Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6310
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Austin, Texas, United States, 78701
        • Children's Hospital of Austin
      • Corpus Christi, Texas, United States, 78411-1721
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75390-9063
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Lubbock, Texas, United States, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, United States, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, United States, 78207
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Hospital
      • Richmond, Virginia, United States, 23298-0121
        • Massey Cancer Center at Virginia Commonwealth University
      • Roanoke, Virginia, United States, 24029
        • Carilion Cancer Center of Western Virginia
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Spokane, Washington, United States, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center
      • Tacoma, Washington, United States, 98405
        • Mary Bridge Children's Hospital and Health Center - Tacoma
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, United States, 25701
        • Cabell Huntington Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • St. Vincent Hospital
      • La Crosse, Wisconsin, United States, 54601-5429
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Midwest Children's Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Complete remission rate

Secondary Outcome Measures

Outcome Measure
Feasibility
Effect of karyotypic abnormalities

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 3, 2003

First Submitted That Met QC Criteria

October 6, 2003

First Posted (Estimate)

October 7, 2003

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML03P1
  • CDR0000330133 (Other Identifier: Clinical Trials.gov)
  • COG-AAML03P1 (Other Identifier: Children's Oncology Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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