{"groups":[{"description":"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.","id":"FG000","title":"Single Arm Nilotinib Relapse Prophylaxis"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"}],"type":"Progressive leukemia"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Critically ill"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Corrected QT interval (QTc) >450 msec"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Myocardial infarction"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"ANC<1500, plts<20K or hyperbilirubinemia"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Miscellaneous (unanticipated) other"}],"milestones":[{"achievements":[{"comment":"57 agreed to participate and completed informed consent (= the 1st \"intention to treat\" population)","groupId":"FG000","numSubjects":"57"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"17"}],"type":"Ineligible for Study Drug"},{"achievements":[{"comment":"40 of 57 originally consented subjects remained eligible at engraftment (= the 2nd ITT population)","groupId":"FG000","numSubjects":"40"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"From Consent to Engraftment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"11"}],"type":"Failed pre-1st dose criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Relapse (1 Central Nervous System, 3 BM)"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adenocarcinoma"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Liver GVHD"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Suicide"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Acute respiratory distress syndrome"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Dyspnea (unrelated to nilotinib)"},{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Toxicity attributed to Nilotinib"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"40"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"}],"type":"Patient Drop-outs"},{"achievements":[{"groupId":"FG000","numSubjects":"13"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"27"}],"type":"NOT COMPLETED"}],"title":"From Engraftment to Study Completion"}]}