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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 CC-401-AML-001是一项单中心、开放标签、序贯剂量递增的I期研究，CC-401作为成人高危髓系白血病受试者的静脉输液。这项研究将分两个阶段进行：1)治疗阶段和2)部分缓解或完全缓解受试者的后续阶段。治疗阶段可分为诱导期和缓解后两个治疗期。缓解后的治疗只给予那些完全缓解的受试者。 将使用当地的血液学、血液病理学和化学实验室。骨髓抽吸/活组织检查样本和细胞遗传学研究将在临床现场进行本地评估，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。 对可能符合议定书条件的受试者的筛选过程将不会超过28天，并将如表2：评估时间表所述进行。

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.