AzTrials
AzTrials

LeukemiaPhase 2NCT00070174

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

A Phase 2 study testing asparaginase, busulfan and cyclophosphamide in people with Leukemia, run by Children's Oncology Group at 148 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia
What is being tested?
asparaginase, busulfan and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
350 participants
Where
148 sitesin 5 countries
Study dates
Dec 2003to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

148 sites in 5 countries.

148 sites in 5 countries

United States134 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-0001

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • C.S. Mott Children's Hospital at University of Michigan

    Ann Arbor, Michigan, 48109-0238

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801-4690

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287-5001

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712-6297

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201-5493

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05405

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7220

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1463

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106-5000

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-5217

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203-6897

  • Columbus Children's Hospital

    Columbus, Ohio, 43205-2696

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411-1721

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9063

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404-1815

  • Children's Hospital Cancer Center

    Denver, Colorado, 80218-1088

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Southern California Permanente Medical Group

    Downey, California, 90242-2814

  • Breslin Cancer Center at Ingham Regional Medical Center

    East Lansing, Michigan, 48824-1313

  • INOVA Fairfax Hospital

    Fairfax, Virginia, 22031

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida, 33908

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503-2560

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27834

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Point Woods, Michigan, 48236

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Hartford, Connecticut, 06106

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 95813

  • Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5225

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1083

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-5341

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2511

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601-5429

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109-2306

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40506

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354-2870

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048-1865

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-1822

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33101

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Children's Hospitals and Clinics - Minneapolis/St. Paul

    Minneapolis, Minnesota, 55404

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455-0392

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6310

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032-1537

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital and Research Center - Oakland

    Oakland, California, 94609-1809

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114-4113

  • Children's Hospital of Orange County

    Orange, California, 92668

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32804

  • M.D. Anderson Cancer Center - Orlando

    Orlando, Florida, 32806

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-9786

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2583

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0121

  • Carilion Cancer Center of Western Virginia

    Roanoke, Virginia, 24029

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Sutter Cancer Center

    Sacramento, California, 95819

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229-3993

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31404-6283

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99220-2555

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9230

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Mary Bridge Children's Hospital and Health Center - Tacoma

    Tacoma, Washington, 98405

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • St. Joseph's Cancer Institute at St. Joseph's Hospital

    Tampa, Florida, 33607

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10467

  • Toledo Hospital

    Toledo, Ohio, 43606

  • Medical College of Ohio Cancer Institute

    Toledo, Ohio, 43608

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007-2197

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19899

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

Other trials in United States

Canada9 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Centre Hospitalier Universitaire de Quebec

    Ste-Foy, Quebec, G1V 4G2

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia3 sites

  • Office of S. David Lang

    Herston, Brisbane, Queensland, 4029

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Puerto Rico1 site

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

Switzerland1 site

  • Swiss Pediatric Oncology Group Bern

    Bern, Chihuahua, 3010

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Leukemia
Being tested
asparaginase, busulfan, cyclophosphamide, cyclosporine, cytarabine
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)
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

  2. Complete remission rate

Secondary outcomes (2)

  1. Feasibility

  2. Effect of karyotypic abnormalities

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study startDec 2003
  3. Primary completionSep 2006
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070174
Sponsor's protocol ID
AAML03P1
Other IDs
CDR0000330133, COG-AAML03P1
Status last verified
Feb 2014
First submitted
3 Oct 2003
Last updated
20 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Pollard JA, Alonzo TA, Loken M, Gerbing RB, Ho PA, Bernstein ID, Raimondi SC, Hirsch B, Franklin J, Walter RB, Gamis A, Meshinchi S. Correlation of CD33 expression level with disease characteristics and response to gemtuzumab ozogamicin containing chemotherapy in childhood AML. Blood. 2012 Apr 19;119(16):3705-11. doi: 10.1182/blood-2011-12-398370. Epub 2012 Feb 29.

    PubMed 22378848

  • Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.

    PubMed 21873548

  • Ho PA, Kuhn J, Gerbing RB, Pollard JA, Zeng R, Miller KL, Heerema NA, Raimondi SC, Hirsch BA, Franklin JL, Lange B, Gamis AS, Alonzo TA, Meshinchi S. WT1 synonymous single nucleotide polymorphism rs16754 correlates with higher mRNA expression and predicts significantly improved outcome in favorable-risk pediatric acute myeloid leukemia: a report from the children's oncology group. J Clin Oncol. 2011 Feb 20;29(6):704-11. doi: 10.1200/JCO.2010.31.9327. Epub 2010 Dec 28.

    PubMed 21189390

  • Ho PA, Alonzo TA, Kopecky KJ, Miller KL, Kuhn J, Zeng R, Gerbing RB, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Reaman GH, Baker LH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Molecular alterations of the IDH1 gene in AML: a Children's Oncology Group and Southwest Oncology Group study. Leukemia. 2010 May;24(5):909-13. doi: 10.1038/leu.2010.56. Epub 2010 Apr 8.

    PubMed 20376086

  • Ho PA, Zeng R, Alonzo TA, Gerbing RB, Miller KL, Pollard JA, Stirewalt DL, Heerema NA, Raimondi SC, Hirsch B, Franklin JL, Lange B, Meshinchi S. Prevalence and prognostic implications of WT1 mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2010 Aug 5;116(5):702-10. doi: 10.1182/blood-2010-02-268953. Epub 2010 Apr 22.

    PubMed 20413658

  • Phillips CL, Gerbing R, Alonzo T, Perentesis JP, Harley IT, Meshinchi S, Bhatla D, Radloff G, Davies SM. MDM2 polymorphism increases susceptibility to childhood acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Aug;55(2):248-53. doi: 10.1002/pbc.22519.

    PubMed 20582981

  • 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.

    PubMed 20056794

  • 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.

    PubMed 21358716

  • Ho PA, Alonzo TA, Gerbing RB, Pollard J, Stirewalt DL, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Radich JP, Meshinchi S. Prevalence and prognostic implications of CEBPA mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2009 Jun 25;113(26):6558-66. doi: 10.1182/blood-2008-10-184747. Epub 2009 Mar 20.

    PubMed 19304957

  • 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.

    PubMed 18680152

  • Pollard J, Alonzo T, Gerbing R, et al.: Prevalence and prognostic significance of c-KIT mutations in pediatric CBF AML patients enrolled on serial CCG/COG protocols. [Abstract] Blood 110 (11): A-1442, 2007.

  • Cooper TM, Franklin J, Gerbing RB, Alonzo TA, Hurwitz C, Raimondi SC, Hirsch B, Smith FO, Mathew P, Arceci RJ, Feusner J, Iannone R, Lavey RS, Meshinchi S, Gamis A. AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: a report from the Children's Oncology Group. Cancer. 2012 Feb 1;118(3):761-9. doi: 10.1002/cncr.26190. Epub 2011 Jul 15.

    PubMed 21766293

  • Gudgeon CJ, Harrington KH, Laszlo GS, Alonzo TA, Gerbing RB, Gamis AS, Raimondi SC, Hirsch BA, Meshinchi S, Walter RB. High expression of neutrophil elastase predicts improved survival in pediatric acute myeloid leukemia: a report from the Children's Oncology Group. Leuk Lymphoma. 2013 Jan;54(1):202-4. doi: 10.3109/10428194.2012.700480. Epub 2012 Jul 9. No abstract available.

    PubMed 22680764

  • Loken MR, Alonzo TA, Pardo L, Gerbing RB, Raimondi SC, Hirsch BA, Ho PA, Franklin J, Cooper TM, Gamis AS, Meshinchi S. Residual disease detected by multidimensional flow cytometry signifies high relapse risk in patients with de novo acute myeloid leukemia: a report from Children's Oncology Group. Blood. 2012 Aug 23;120(8):1581-8. doi: 10.1182/blood-2012-02-408336. Epub 2012 May 30.

    PubMed 22649108

  • Ho PA, Kutny MA, Alonzo TA, Gerbing RB, Joaquin J, Raimondi SC, Gamis AS, Meshinchi S. Leukemic mutations in the methylation-associated genes DNMT3A and IDH2 are rare events in pediatric AML: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Aug;57(2):204-9. doi: 10.1002/pbc.23179. Epub 2011 Apr 18.

    PubMed 21504050

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing asparaginase, busulfan and cyclophosphamide in people with Leukemia, run by Children's Oncology Group at 148 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Canada, Australia, Puerto Rico, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070174, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.

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