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| ID | Type | Description | Link |
|---|---|---|---|
| COG-AAML0531 | Other Identifier | Children's Oncology Group | |
| CDR0000487497 | Other Identifier | Clinical Trials.gov | |
| NCI-2009-00320 | Registry Identifier | Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse risk (high vs intermediate vs low). Patients are randomized to 1 of 2 treatment arms. Patients with Down syndrome are nonrandomly assigned to arm I (but do not undergo allogeneic stem cell transplant [SCT]).
Arm I (standard therapy):
NOTE: *Patients with Central Nervous System (CNS) disease receive cytarabine IT twice weekly until the cerebrospinal fluid is clear, followed by two additional IT treatments. Patients with refractory CNS leukemia after 6 doses of IT treatment are removed from the study.
Induction 2: Patients receive cytarabine IT on day 1, cytarabine IV on days 1-8, daunorubicin hydrochloride IV over 6 hours on days 1, 3, and 5, and etoposide IV over 4 hours on days 1-5. After 3 weeks of rest, patients in complete remission (CR) proceed to intensification 1. Patients with refractory disease are removed from protocol therapy.
Intensification 1: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 1 hour on days 1-5, and etoposide IV over 1 hour on days 1-5. After 3 weeks of rest, patients in remission proceed to intensification 2, followed by intensification 3. Patients in remission proceed to allogeneic SCT 2-8 weeks after blood counts recover. Patients with high-risk disease with an alternative donor proceed to intensification 2 and 3, followed by allogeneic SCT. Patients not in remission are removed from protocol therapy.
Intensification 2: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 2 hours on days 1-4, and mitoxantrone hydrochloride IV over 1 hour on days 3-6. After 3 weeks of rest, patients proceed to intensification 3.
Intensification 3: Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.
Induction 1: Patients receive treatment as in induction 1 of arm I. Patients also receive gemtuzumab ozogamicin (GMTZ) IV over 2 hours on day 6.
Induction 2: Patients receive treatment as in induction 2 of arm I.
Intensification 1: Patients receive treatment as in intensification 1 of arm I.
Intensification 2: Patients receive treatment as in intensification 2 of arm I. Patients also receive GMTZ IV over 2 hours on day 7.
Intensification 3: Patients receive treatment as in intensification 3 of arm I.
MFD: Patients receive a conditioning regimen comprising busulfan IV over 2 hours every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. Patients undergo allogeneic SCT on day 0. Patients receive cyclosporine IV or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11.
Matched alternative donor: Patients receive a conditioning regimen comprising busulfan and cyclophosphamide as above. Patients also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1. Patients then undergo allogeneic SCT and receive GVHD prophylaxis as above.
After completion of study treatment, patients are followed periodically for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,012 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome | Active Comparator | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
| Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome | Experimental | Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asparaginase | Drug | Given intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival at 3 Years | The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error. | Time from study entry to time of induction failure, relapse, or death, assessed at 3 years |
| Overall Survival at 3 Years | The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error. | Time from study entry, assessed at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Induction Rate After 2 Courses of Induction Therapy | Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II. |
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DISEASE CHARACTERISTICS:
Newly diagnosed acute myeloid leukemia (AML)
Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO classification)
Patients with < 20% bone marrow blasts and cytopenia or myelodysplastic syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of the following criteria is met:
Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of bone marrow results
Infants < 1 month of age with progressive disease* are eligible NOTE: *Infants < 1 month of age with AML may be given supportive care until it is clear that the leukemia is not regressing (i.e., the disappearance of peripheral blasts and the normalization of peripheral blood counts)
Patients with Down syndrome ≥ 4 years of age are eligible
No juvenile myelomonocytic leukemia
No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
No promyelocytic leukemia (M3)
No secondary or treatment-related AML
Matched family donor criteria (for patients with intermediate-risk or high-risk disease):
Matched alternative donor criteria (for patients with high-risk disease):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy, radiation therapy, or any antileukemic therapy
No other prior treatment for AML
No concurrent peripheral blood stem cell transplantation in patients with matched family donor
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| Name | Affiliation | Role |
|---|---|---|
| Alan S. Gamis, MD, MPH | Children's Mercy Hospital Kansas City | Study Chair |
| Richard Aplenc, MD, MSCE | Children's Hospital of Philadelphia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| University of South Alabama Mitchell Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22378848 | Background | 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. | |
| 25092781 |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome | Active Comparator | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
|
| cytarabine | Drug | Given IV |
|
|
| daunorubicin hydrochloride | Drug | Given IV over 6 hours |
|
|
| etoposide | Drug | Given IV over 1-4 hours |
|
|
| gemtuzumab ozogamicin | Drug | Given IV over 2 hours |
|
|
| mitoxantrone hydrochloride | Drug | Given IV over 1 hour |
|
|
| After 2 courses of induction (I and II) therapy, assessed for up to 10 years |
| Disease-free Survival (DFS) | Time from end of Intensification I to relapse, death or last contact | At 3 years from end of Intensification I |
| Mortality | Number of participants who died during the first three courses of therapy. | During the first three courses of therapy |
| Time to Marrow Recovery | Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days. | At 25 days after treatment with Induction I, Induction II, and Intensification I |
| Toxicities, Including Infectious Complications | Number of participants with at least one grade 3 or higher adverse event during therapy. | From the time therapy is initiated, assessed up to 10 years |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Banner Desert Medical Center | Mesa | Arizona | 85202 | United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724-5024 | United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Southern California Permanente Medical Group | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | 90048-1865 | United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Children's Hospital Central California | Madera | California | 93636-8762 | United States |
| Children's Hospital and Research Center Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente Medical Center - Oakland | Oakland | California | 94611 | United States |
| Children's Hospital of Orange County | Orange | California | 92868-3874 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123-4282 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Santa Barbara Cottage Children's Hospital | Santa Barbara | California | 93105 | United States |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Torrance | California | 90502 | United States |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | 80045 | United States |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | 06360-2875 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | 33316 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207-8426 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Baptist-South Miami Regional Cancer Program | Miami | Florida | 33176 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Tripler Army Medical Center | Tripler AMC | Hawaii | 96859-5000 | United States |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | United States |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | United States |
| Simmons Cooper Cancer Institute | Springfield | Illinois | 62794-9677 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Children's Hospital of New Orleans | New Orleans | Louisiana | 70118 | United States |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | Portland | Maine | 04102 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | 21215 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts | 01199-0001 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49008 | United States |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Children's Hospital | Omaha | Nebraska | 68114-4113 | United States |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| St. Joseph's Hospital and Medical Center | Paterson | New Jersey | 07503 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Albany Medical Center Hospital | Albany | New York | 12208 | United States |
| Brooklyn Hospital Center | Brooklyn | New York | 11201-5493 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Schneider Children's Hospital | New Hyde Park | New York | 11040 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-9446 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27834 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Children's Medical Center - Dayton | Dayton | Ohio | 45404 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | 29203 | United States |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| T.C. Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | 79106 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Baylor University Medical Center - Houston | Houston | Texas | 77030 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042-3300 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | 24014 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center - Tacoma | Tacoma | Washington | 98431 | United States |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25302 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Children's Hospital | Herston | Queensland | 4029 | Australia |
| Women's and Children's Hospital | North Adelaide | South Australia | 5006 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| Children's Hospital of Western Ontario | London | Ontario | N6A 5W9 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1V 4G2 | Canada |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Starship Children's Health | Grafton | 1145 | New Zealand |
| San Jorge Children's Hospital | Santurce | 00912 | Puerto Rico |
| Swiss Pediatric Oncology Group Bern | Bern | 3010 | Switzerland |
| Swiss Pediatric Oncology Group Geneva | Geneva | 1205 | Switzerland |
| Gamis AS, Alonzo TA, Meshinchi S, Sung L, Gerbing RB, Raimondi SC, Hirsch BA, Kahwash SB, Heerema-McKenney A, Winter L, Glick K, Davies SM, Byron P, Smith FO, Aplenc R. Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children's Oncology Group trial AAML0531. J Clin Oncol. 2014 Sep 20;32(27):3021-32. doi: 10.1200/JCO.2014.55.3628. |
| 42085603 | Derived | Scheidegger N, Schneider C, Alexe G, Wang YC, Alonzo TA, Basanthakumar A, Bourgeois WA, Dudkiewicz-Garbicz J, Khalid D, Merickel LA, Perry JA, Ries RE, Salhotra S, Taillon A, Gamis A, Aplenc R, Harris MH, Wunderlich M, Armstrong SA, Pollard JA, Meshinchi S, Pikman Y, Stegmaier K. Combining menin and MEK inhibition to target poor prognosis KMT2A-rearranged RAS pathway-mutant acute myeloid leukemia. Blood Adv. 2026 Jul 14;10(13):4757-4771. doi: 10.1182/bloodadvances.2025016208. |
| 40294366 | Derived | Huang BJ, Meyer LK, Alonzo TA, Wang YC, Lamble AJ, Ries RE, Wang W, Hirsch B, Raca G, Ma X, Gamis AS, Aplenc R, Kolb EA, Cooper TM, Tarlock K, Loken MR, Meshinchi S, Chewning JH, Woods WG, Horan JT. Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group. J Clin Oncol. 2025 Jun 10;43(17):1961-1971. doi: 10.1200/JCO-24-01841. Epub 2025 Apr 28. |
| 38295280 | Derived | Tarlock K, Gerbing RB, Ries RE, Smith JL, Leonti A, Huang BJ, Kirkey D, Robinson L, Peplinski JH, Lange B, Cooper TM, Gamis AS, Kolb EA, Aplenc R, Pollard JA, Alonzo TA, Meshinchi S. Prognostic impact of cooccurring mutations in FLT3-ITD pediatric acute myeloid leukemia. Blood Adv. 2024 May 14;8(9):2094-2103. doi: 10.1182/bloodadvances.2023011980. |
| 37267439 | Derived | Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282. |
| 36815378 | Derived | Bertrums EJM, Smith JL, Harmon L, Ries RE, Wang YJ, Alonzo TA, Menssen AJ, Chisholm KM, Leonti AR, Tarlock K, Ostronoff F, Pogosova-Agadjanyan EL, Kaspers GJL, Hasle H, Dworzak M, Walter C, Muhlegger N, Morerio C, Pardo L, Hirsch B, Raimondi S, Cooper TM, Aplenc R, Gamis AS, Kolb EA, Farrar JE, Stirewalt D, Ma X, Shaw TI, Furlan SN, Brodersen LE, Loken MR, Van den Heuvel-Eibrink MM, Zwaan CM, Triche TJ, Goemans BF, Meshinchi S. Comprehensive molecular and clinical characterization of NUP98 fusions in pediatric acute myeloid leukemia. Haematologica. 2023 Aug 1;108(8):2044-2058. doi: 10.3324/haematol.2022.281653. |
| 34596937 | Derived | Elgarten CW, Wood AC, Li Y, Alonzo TA, Brodersen LE, Gerbing RB, Getz KD, Huang YV, Loken M, Meshinchi S, Pollard JA, Sung L, Woods WG, Kolb EA, Gamis AS, Aplenc R. Outcomes of intensification of induction chemotherapy for children with high-risk acute myeloid leukemia: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2021 Dec;68(12):e29281. doi: 10.1002/pbc.29281. Epub 2021 Oct 1. |
| 33080007 | Derived | Brodersen LE, Gerbing RB, Pardo ML, Alonzo TA, Paine D, Fritschle W, Hsu FC, Pollard JA, Aplenc R, Kahwash SB, Hirsch B, Ramondi S, Wells D, Kolb EA, Gamis AS, Meshinchi S, Loken MR. Morphologic remission status is limited compared to DeltaN flow cytometry: a Children's Oncology Group AAML0531 report. Blood Adv. 2020 Oct 27;4(20):5050-5061. doi: 10.1182/bloodadvances.2020002070. |
| 28883080 | Derived | Voigt AP, Brodersen LE, Alonzo TA, Gerbing RB, Menssen AJ, Wilson ER, Kahwash S, Raimondi SC, Hirsch BA, Gamis AS, Meshinchi S, Wells DA, Loken MR. Phenotype in combination with genotype improves outcome prediction in acute myeloid leukemia: a report from Children's Oncology Group protocol AAML0531. Haematologica. 2017 Dec;102(12):2058-2068. doi: 10.3324/haematol.2017.169029. Epub 2017 Sep 7. |
| 27133823 | Derived | Eidenschink Brodersen L, Alonzo TA, Menssen AJ, Gerbing RB, Pardo L, Voigt AP, Kahwash SB, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Loken MR. A recurrent immunophenotype at diagnosis independently identifies high-risk pediatric acute myeloid leukemia: a report from Children's Oncology Group. Leukemia. 2016 Oct;30(10):2077-2080. doi: 10.1038/leu.2016.119. Epub 2016 May 2. No abstract available. |
| 23471307 | Derived | Sung L, Aplenc R, Alonzo TA, Gerbing RB, Lehrnbecher T, Gamis AS. Effectiveness of supportive care measures to reduce infections in pediatric AML: a report from the Children's Oncology Group. Blood. 2013 May 2;121(18):3573-7. doi: 10.1182/blood-2013-01-476614. Epub 2013 Mar 7. |
| FG001 | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| FG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| BG001 | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| BG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival at 3 Years | The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error. | Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from study entry to time of induction failure, relapse, or death, assessed at 3 years |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Overall Survival at 3 Years | The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error. | Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from study entry, assessed at 3 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Remission Induction Rate After 2 Courses of Induction Therapy | Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II. | Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45). | Posted | Number | Proportion of participants | After 2 courses of induction (I and II) therapy, assessed for up to 10 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | Time from end of Intensification I to relapse, death or last contact | Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247). | Posted | Number | 95% Confidence Interval | Percentage participants DFS at 3 years | At 3 years from end of Intensification I |
| |||||||||||||||||||||||||||||||||
| Secondary | Mortality | Number of participants who died during the first three courses of therapy. | Ineligible (n=42) patients are excluded. | Posted | Number | Number of participants | During the first three courses of therapy |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Marrow Recovery | Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days. | Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182) | Posted | Mean | Standard Deviation | Mean days | At 25 days after treatment with Induction I, Induction II, and Intensification I |
| |||||||||||||||||||||||||||||||||
| Secondary | Toxicities, Including Infectious Complications | Number of participants with at least one grade 3 or higher adverse event during therapy. | Ineligible (n=42) patients are excluded. | Posted | Number | Number of participants | From the time therapy is initiated, assessed up to 10 years |
|
Not provided
SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. | 26 | 511 | 482 | 511 | ||
| EG001 | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. | 32 | 511 | 479 | 511 | ||
| EG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. | 2 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders |
| |||
| Acute kidney injury | Renal and urinary disorders |
| |||
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Atrial flutter | Cardiac disorders |
| |||
| Blood bilirubin increased | Investigations |
| |||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders |
| |||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders |
| |||
| Cardiac disorders - Other | Cardiac disorders |
| |||
| Confusion | Psychiatric disorders |
| |||
| Creatinine increased | Investigations |
| |||
| Death NOS | General disorders |
| |||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Electrocardiogram QT corrected interval prolonged | Investigations |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Enterocolitis infectious | Infections and infestations |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Fibrinogen decreased | Investigations |
| |||
| Gastritis | Gastrointestinal disorders |
| |||
| Heart failure | Cardiac disorders |
| |||
| Hepatic failure | Hepatobiliary disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Infections and infestations - Other | Infections and infestations |
| |||
| Intracranial hemorrhage | Nervous system disorders |
| |||
| Investigations - Other | Investigations |
| |||
| Left ventricular systolic dysfunction | Cardiac disorders |
| |||
| Lipase increased | Investigations |
| |||
| Lung infection | Infections and infestations |
| |||
| Mucositis oral | Gastrointestinal disorders |
| |||
| Multi-organ failure | General disorders |
| |||
| Nervous system disorders - Other | Nervous system disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Pericardial effusion | Cardiac disorders |
| |||
| Pericarditis | Cardiac disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Portal hypertension | Hepatobiliary disorders |
| |||
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders |
| |||
| Restrictive cardiomyopathy | Cardiac disorders |
| |||
| Right ventricular dysfunction | Cardiac disorders |
| |||
| Seizure | Nervous system disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Serum amylase increased | Investigations |
| |||
| Sudden death NOS | General disorders |
| |||
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Vascular disorders - Other | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders |
| |||
| Abdominal infection | Infections and infestations |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Abducens nerve disorder | Nervous system disorders |
| |||
| Acidosis | Metabolism and nutrition disorders |
| |||
| Activated partial thromboplastin time prolonged | Investigations |
| |||
| Acute kidney injury | Renal and urinary disorders |
| |||
| Adrenal insufficiency | Endocrine disorders |
| |||
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Agitation | Psychiatric disorders |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Alkaline phosphatase increased | Investigations |
| |||
| Alkalosis | Metabolism and nutrition disorders |
| |||
| Allergic reaction | Immune system disorders |
| |||
| Anal mucositis | Gastrointestinal disorders |
| |||
| Anal pain | Gastrointestinal disorders |
| |||
| Anal ulcer | Gastrointestinal disorders |
| |||
| Anaphylaxis | Immune system disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Anorectal infection | Infections and infestations |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Apnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Appendicitis | Infections and infestations |
| |||
| Arachnoiditis | Nervous system disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Aspartate aminotransferase increased | Investigations |
| |||
| Aspiration | Respiratory, thoracic and mediastinal disorders |
| |||
| Ataxia | Nervous system disorders |
| |||
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Avascular necrosis | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Bladder infection | Infections and infestations |
| |||
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders |
| |||
| Blood bilirubin increased | Investigations |
| |||
| Blurred vision | Eye disorders |
| |||
| Bone infection | Infections and infestations |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Bronchial infection | Infections and infestations |
| |||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders |
| |||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders |
| |||
| Burn | Injury, poisoning and procedural complications |
| |||
| Buttock pain | Musculoskeletal and connective tissue disorders |
| |||
| Capillary leak syndrome | Vascular disorders |
| |||
| Cardiac arrest | Cardiac disorders |
| |||
| Cardiac disorders - Other | Cardiac disorders |
| |||
| Cardiac troponin T increased | Investigations |
| |||
| Catheter related infection | Infections and infestations |
| |||
| Cheilitis | Gastrointestinal disorders |
| |||
| Chest wall pain | Musculoskeletal and connective tissue disorders |
| |||
| Chills | General disorders |
| |||
| Cholecystitis | Hepatobiliary disorders |
| |||
| Chronic kidney disease | Renal and urinary disorders |
| |||
| Colitis | Gastrointestinal disorders |
| |||
| Colonic fistula | Gastrointestinal disorders |
| |||
| Colonic hemorrhage | Gastrointestinal disorders |
| |||
| Confusion | Psychiatric disorders |
| |||
| Conjunctivitis | Eye disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| CPK increased | Investigations |
| |||
| Creatinine increased | Investigations |
| |||
| Cystitis noninfective | Renal and urinary disorders |
| |||
| Cytokine release syndrome | Immune system disorders |
| |||
| Death NOS | General disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Dental caries | Gastrointestinal disorders |
| |||
| Depressed level of consciousness | Nervous system disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Duodenal hemorrhage | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Ear pain | Ear and labyrinth disorders |
| |||
| Edema face | General disorders |
| |||
| Edema limbs | General disorders |
| |||
| Edema trunk | General disorders |
| |||
| Electrocardiogram QT corrected interval prolonged | Investigations |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Endocrine disorders - Other | Endocrine disorders |
| |||
| Enterocolitis | Gastrointestinal disorders |
| |||
| Enterocolitis infectious | Infections and infestations |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Erythema multiforme | Skin and subcutaneous tissue disorders |
| |||
| Esophageal hemorrhage | Gastrointestinal disorders |
| |||
| Esophageal pain | Gastrointestinal disorders |
| |||
| Esophagitis | Gastrointestinal disorders |
| |||
| Euphoria | Psychiatric disorders |
| |||
| External ear pain | Ear and labyrinth disorders |
| |||
| Eye disorders - Other | Eye disorders |
| |||
| Eye infection | Infections and infestations |
| |||
| Eye pain | Eye disorders |
| |||
| Facial nerve disorder | Nervous system disorders |
| |||
| Facial pain | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Fever | General disorders |
| |||
| Fibrinogen decreased | Investigations |
| |||
| Fracture | Injury, poisoning and procedural complications |
| |||
| Gallbladder infection | Infections and infestations |
| |||
| Gallbladder necrosis | Hepatobiliary disorders |
| |||
| Gallbladder obstruction | Hepatobiliary disorders |
| |||
| Gallbladder pain | Hepatobiliary disorders |
| |||
| Gastric hemorrhage | Gastrointestinal disorders |
| |||
| Gastritis | Gastrointestinal disorders |
| |||
| Gastrointestinal disorders - Other | Gastrointestinal disorders |
| |||
| Gastrointestinal pain | Gastrointestinal disorders |
| |||
| General disorders and administration site conditions - Other | General disorders |
| |||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
| |||
| GGT increased | Investigations |
| |||
| Gingival pain | Gastrointestinal disorders |
| |||
| Glucose intolerance | Metabolism and nutrition disorders |
| |||
| Gum infection | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Hearing impaired | Ear and labyrinth disorders |
| |||
| Heart failure | Cardiac disorders |
| |||
| Hematoma | Vascular disorders |
| |||
| Hematuria | Renal and urinary disorders |
| |||
| Hemorrhoids | Gastrointestinal disorders |
| |||
| Hepatic failure | Hepatobiliary disorders |
| |||
| Hepatic pain | Hepatobiliary disorders |
| |||
| Hepatobiliary disorders - Other | Hepatobiliary disorders |
| |||
| Hydrocephalus | Nervous system disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypermagnesemia | Metabolism and nutrition disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Hypertriglyceridemia | Metabolism and nutrition disorders |
| |||
| Hyperuricemia | Metabolism and nutrition disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Ileus | Gastrointestinal disorders |
| |||
| Immune system disorders - Other | Immune system disorders |
| |||
| Infections and infestations - Other | Infections and infestations |
| |||
| Infective myositis | Infections and infestations |
| |||
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications |
| |||
| INR increased | Investigations |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Intra-abdominal hemorrhage | Gastrointestinal disorders |
| |||
| Intracranial hemorrhage | Nervous system disorders |
| |||
| Intraoperative gastrointestinal injury | Injury, poisoning and procedural complications |
| |||
| Intraoperative respiratory injury | Injury, poisoning and procedural complications |
| |||
| Investigations - Other | Investigations |
| |||
| Joint effusion | Musculoskeletal and connective tissue disorders |
| |||
| Kidney infection | Infections and infestations |
| |||
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders |
| |||
| Left ventricular systolic dysfunction | Cardiac disorders |
| |||
| Lip infection | Infections and infestations |
| |||
| Lip pain | Gastrointestinal disorders |
| |||
| Lipase increased | Investigations |
| |||
| Localized edema | General disorders |
| |||
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders |
| |||
| Lung infection | Infections and infestations |
| |||
| Lymph gland infection | Infections and infestations |
| |||
| Malabsorption | Gastrointestinal disorders |
| |||
| Meningitis | Infections and infestations |
| |||
| Middle ear inflammation | Ear and labyrinth disorders |
| |||
| Mucosal infection | Infections and infestations |
| |||
| Mucositis oral | Gastrointestinal disorders |
| |||
| Multi-organ failure | General disorders |
| |||
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Myocarditis | Cardiac disorders |
| |||
| Myositis | Musculoskeletal and connective tissue disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Neck pain | Musculoskeletal and connective tissue disorders |
| |||
| Nervous system disorders - Other | Nervous system disorders |
| |||
| Neuralgia | Nervous system disorders |
| |||
| Neutrophil count decreased | Investigations |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Oculomotor nerve disorder | Nervous system disorders |
| |||
| Oral hemorrhage | Gastrointestinal disorders |
| |||
| Oral pain | Gastrointestinal disorders |
| |||
| Otitis media | Infections and infestations |
| |||
| Pain | General disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Pain of skin | Skin and subcutaneous tissue disorders |
| |||
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders |
| |||
| Pancreatitis | Gastrointestinal disorders |
| |||
| Paroxysmal atrial tachycardia | Cardiac disorders |
| |||
| Pelvic pain | Reproductive system and breast disorders |
| |||
| Penile infection | Infections and infestations |
| |||
| Penile pain | Reproductive system and breast disorders |
| |||
| Pericardial effusion | Cardiac disorders |
| |||
| Pericarditis | Cardiac disorders |
| |||
| Perineal pain | Reproductive system and breast disorders |
| |||
| Peripheral motor neuropathy | Nervous system disorders |
| |||
| Peripheral sensory neuropathy | Nervous system disorders |
| |||
| Personality change | Psychiatric disorders |
| |||
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Photophobia | Eye disorders |
| |||
| Platelet count decreased | Investigations |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
| |||
| Portal hypertension | Hepatobiliary disorders |
| |||
| Postoperative hemorrhage | Injury, poisoning and procedural complications |
| |||
| Proctitis | Gastrointestinal disorders |
| |||
| Proteinuria | Renal and urinary disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Psychosis | Psychiatric disorders |
| |||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders |
| |||
| Purpura | Skin and subcutaneous tissue disorders |
| |||
| Rash maculo-papular | Skin and subcutaneous tissue disorders |
| |||
| Rectal fistula | Gastrointestinal disorders |
| |||
| Rectal hemorrhage | Gastrointestinal disorders |
| |||
| Rectal mucositis | Gastrointestinal disorders |
| |||
| Rectal pain | Gastrointestinal disorders |
| |||
| Renal and urinary disorders - Other | Renal and urinary disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders |
| |||
| Restrictive cardiomyopathy | Cardiac disorders |
| |||
| Rhinitis infective | Infections and infestations |
| |||
| Right ventricular dysfunction | Cardiac disorders |
| |||
| Scrotal infection | Infections and infestations |
| |||
| Seizure | Nervous system disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Serum amylase increased | Investigations |
| |||
| Sinus bradycardia | Cardiac disorders |
| |||
| Sinus disorder | Respiratory, thoracic and mediastinal disorders |
| |||
| Sinus tachycardia | Cardiac disorders |
| |||
| Sinusitis | Infections and infestations |
| |||
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders |
| |||
| Skin induration | Skin and subcutaneous tissue disorders |
| |||
| Skin infection | Infections and infestations |
| |||
| Skin ulceration | Skin and subcutaneous tissue disorders |
| |||
| Small intestinal mucositis | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Small intestine infection | Infections and infestations |
| |||
| Soft tissue infection | Infections and infestations |
| |||
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders |
| |||
| Stomach pain | Gastrointestinal disorders |
| |||
| Supraventricular tachycardia | Cardiac disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Thromboembolic event | Vascular disorders |
| |||
| Tinnitus | Ear and labyrinth disorders |
| |||
| Tooth infection | Infections and infestations |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Tracheal hemorrhage | Injury, poisoning and procedural complications |
| |||
| Tracheitis | Infections and infestations |
| |||
| Tumor lysis syndrome | Metabolism and nutrition disorders |
| |||
| Typhlitis | Gastrointestinal disorders |
| |||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders |
| |||
| Upper respiratory infection | Infections and infestations |
| |||
| Urinary frequency | Renal and urinary disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Urinary tract obstruction | Renal and urinary disorders |
| |||
| Urinary tract pain | Renal and urinary disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Uterine hemorrhage | Reproductive system and breast disorders |
| |||
| Uterine pain | Reproductive system and breast disorders |
| |||
| Uveitis | Eye disorders |
| |||
| Vaginal hemorrhage | Reproductive system and breast disorders |
| |||
| Vaginal infection | Infections and infestations |
| |||
| Vaginal pain | Reproductive system and breast disorders |
| |||
| Vascular access complication | Injury, poisoning and procedural complications |
| |||
| Vascular disorders - Other | Vascular disorders |
| |||
| Vasculitis | Vascular disorders |
| |||
| Venous injury | Injury, poisoning and procedural complications |
| |||
| Ventricular tachycardia | Cardiac disorders |
| |||
| Vitreous hemorrhage | Eye disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Vulval infection | Infections and infestations |
| |||
| Weight gain | Investigations |
| |||
| Weight loss | Investigations |
| |||
| White blood cell decreased | Investigations |
| |||
| Wound infection | Infections and infestations |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D000013 | Congenital Abnormalities |
| D015471 | Leukemia, Basophilic, Acute |
| D015472 | Leukemia, Eosinophilic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001215 | Asparaginase |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D000079982 | Gemtuzumab |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D000080084 | Calicheamicins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Canada |
|
| Australia |
|
| Switzerland |
|
| New Zealand |
|
| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome |
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
|
| OG001 | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
|
| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
|
| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
|
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| Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome |
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
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| OG002 | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9. |
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