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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.","id":"BG000","title":"Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome"},{"description":"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.","id":"BG001","title":"Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome"},{"description":"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.","id":"BG002","title":"Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"2336.55","value":"3352.86"},{"groupId":"BG001","spread":"2283.45","value":"3466"},{"groupId":"BG002","spread":"1979.95","value":"4206.71"},{"groupId":"BG003","spread":"2310","value":"3409.43"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"days"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"516"},{"groupId":"BG001","value":"510"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"1033"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"37"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"260"},{"groupId":"BG001","value":"277"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"541"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"271"},{"groupId":"BG001","value":"255"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"529"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"4"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"52"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"62"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"122"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"383"},{"groupId":"BG001","value":"394"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"782"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"108"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"197"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"411"},{"groupId":"BG001","value":"416"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"834"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"39"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"473"},{"groupId":"BG001","value":"480"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"958"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"68"}]}],"title":"Canada"},{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"34"}]}],"title":"Australia"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}],"title":"Switzerland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"9"}]}],"title":"New Zealand"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}