SINGLE-CENTER PHASE I STUDY TO DETERMINE THE OPTIMAL BIOLOGIC DOSE OF CC-401

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. CC-401-AML-001 is a single-center, open-label, sequential dose-escalation phase I study of CC-401 given as an intravenous infusion in adult subjects with high-risk myeloid leukemia. The study will be conducted in 2 phases: 1) the Treatment Phase and 2) the Follow-up Phase for subjects achieving Partial Remission or Complete Remission. The Treatment Phase may consist of two treatment periods, induction and post-remission. Post-remission treatment is given only to those subjects who achieve Complete Remission. Local hematology, hematopathology and chemistry laboratories will be used. Bone marrow aspirate/biopsy samples and cytogenetic studies will be assessed locally at the clinical site, except that pharmacodynamic measurements will be performed by Celgene San Diego and pharmacokinetic measurements will be arranged by Celgene. The screening process for potentially protocol-eligible subjects will not last longer than 28 days and will be conducted as outlined in Table 2: Schedule of Assessments.