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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 CC-401-AML-001是一项在高危髓性白血病成人受试者中进行的CC-401静脉输注给药的单中心、开放标签、序贯剂量递增I期研究。本研究将分2个阶段进行：1）治疗阶段和2）随访阶段，用于达到部分缓解或完全缓解的受试者。 治疗期可包括两个治疗期，诱导期和缓解后。 仅对达到完全缓解的受试者进行缓解后治疗。 将使用当地血液学、血液病理学和化学实验室。骨髓穿刺/活检样本和细胞遗传学研究将在当地临床研究中心进行评估，但药效学测量将由Celgene San Diego进行，药代动力学测量将由Celgene安排。 可能符合研究方案条件的受试者的筛选过程将持续不超过28天，并将按照表2：评估时间表中的概述进行。

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.