Leukemia Clinical Trial
Official title:
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
Verified date | February 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 350 |
Est. completion date | December 2013 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Office of S. David Lang | Herston, Brisbane | Queensland |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Australia | Westmead Hospital | Westmead | New South Wales |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | McGill Cancer Centre at McGill University | Montreal | Quebec |
Canada | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador |
Canada | Centre Hospitalier Universitaire de Quebec | Ste-Foy | Quebec |
Canada | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Puerto Rico | San Jorge Children's Hospital | Santurce | |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | Chihuahua |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
United States | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas |
United States | C.S. Mott Children's Hospital at University of Michigan | Ann Arbor | Michigan |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Children's Hospital of Austin | Austin | Texas |
United States | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine |
United States | Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama |
United States | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho |
United States | Floating Hospital for Children | Boston | Massachusetts |
United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
United States | Brooklyn Hospital Center | Brooklyn | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina |
United States | Columbus Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Children's Medical Center - Dayton | Dayton | Ohio |
United States | Children's Hospital Cancer Center | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Southern California Permanente Medical Group | Downey | California |
United States | Breslin Cancer Center at Ingham Regional Medical Center | East Lansing | Michigan |
United States | INOVA Fairfax Hospital | Fairfax | Virginia |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | Broward General Medical Center Cancer Center | Ft. Lauderdale | Florida |
United States | Lee Cancer Care of Lee Memorial Health System | Ft. Myers | Florida |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids | Michigan |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville | North Carolina |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Point Woods | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Hartford | Connecticut |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Cabell Huntington Hospital | Huntington | West Virginia |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | St. Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | Keesler Medical Center - Keesler Air Force Base | Keesler AFB | Mississippi |
United States | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Barnabas Medical Center | Livingston | New Jersey |
United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
United States | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | Children's Hospital Central California | Madera | California |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Baptist-South Miami Regional Cancer Program | Miami | Florida |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Winthrop University Hospital | Mineola | New York |
United States | Children's Hospitals and Clinics - Minneapolis/St. Paul | Minneapolis | Minnesota |
United States | Fairview University Medical Center - University Campus | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Schneider Children's Hospital | New Hyde Park | New York |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital and Research Center - Oakland | Oakland | California |
United States | Oklahoma University Medical Center | Oklahoma City | Oklahoma |
United States | Children's Hospital of Omaha | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida |
United States | M.D. Anderson Cancer Center - Orlando | Orlando | Florida |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia |
United States | Carilion Cancer Center of Western Virginia | Roanoke | Virginia |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Kaiser Permanente Medical Center - Oakland | Sacramento | California |
United States | Sutter Cancer Center | Sacramento | California |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Primary Children's Medical Center | Salt Lake City | Utah |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Children's Hospital and Health Center - San Diego | San Diego | California |
United States | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota |
United States | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Cardinal Glennon Children's Hospital | St. Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | St. Louis | Missouri |
United States | All Children's Hospital | St. Petersburg | Florida |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington |
United States | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | Medical College of Ohio Cancer Institute | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Lombardi Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Alfred I. duPont Hospital for Children | Wilmington | Delaware |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Puerto Rico, Switzerland,
Berman JN, Gerbing RB, Sung L, et al.: Prevalence and clinical implications of N-RAS mutations in childhood AML - A report from the Children's Oncology Group. [Abstract] Blood 114 (22): A-3115, 2009.
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 chemoth — View Citation
Franklin J, Alonzo T, Hurwitz CA, et al.: COG AAML03P1: efficacy and safety in a pilot study of intensive chemotherapy including gemtuzumab in children newly diagnosed with acute myeloid leukemia (AML). [Abstract] Blood 112 (11): A- 136, 2008.
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 Onco — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Canc — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
Walter RB, Alonzo TA, Gerbing RB, et al.: High expression of the very late antigen (VLA)-4 (CD49d) integrin predicts for reduced risk of relapse and better outcome in pediatric acute myeloid leukemia (AML): A report from the Children's Oncology Group. [Ab
Walter RB, Alonzo TA, Gerbing RB, Ho PA, Smith FO, Raimondi SC, Hirsch BA, Gamis AS, Franklin JL, Hurwitz CA, Loken MR, Meshinchi S. High expression of the very late antigen-4 integrin independently predicts reduced risk of relapse and improved outcome in — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Yes | ||
Primary | Complete remission rate | No | ||
Secondary | Feasibility | No | ||
Secondary | Effect of karyotypic abnormalities | No |
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