{"groups":[{"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":"FG000","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 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.","id":"FG001","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":"FG002","title":"Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"71"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"1"}],"type":"Ineligible"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"531"},{"groupId":"FG001","numSubjects":"532"},{"groupId":"FG002","numSubjects":"7"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"327"},{"groupId":"FG001","numSubjects":"334"},{"groupId":"FG002","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"204"},{"groupId":"FG001","numSubjects":"198"},{"groupId":"FG002","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}