CC-486-AML-001: A Phase 3, Randomized, Double-Bind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission

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CC-486-AML-001: A Phase 3, Randomized, Double-Bind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission

Objectives
Primary Objective:
The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves overall survival (OS) compared with placebo in subjects with AML, age ? 55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation
chemotherapy.
Secondary Objectives:
The secondary objectives of the study are:
- To determine relapse-free survival (RFS);
- To determine safety, tolerability; and
- To determine the effect of oral azacitidine compared with placebo on health-related quality-of-life (HRQoL) and healthcare resource utilization.
Exploratory objectives:
The exploratory objectives of the study are:
- To determine complete cytogenetic remission (CRc) rate;
- To evaluate molecular and/or cellular markers in the bone marrow post-induction and during maintenance therapy that may be predictive of clinical outcomes with therapy (placebo or oral azacitidine), including OS and RFS, following CR/CRi; and
- To evaluate exploratory HRQoL measures

Protocol Number021303
Principal InvestigatorDale Schaar
PhasePhase III
ScopeNational
Applicable Disease SitesMyeloid and Monocytic Leukemia
Drugs InvolvedPLACEBO
AZACITIDINE(Vidaza)
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.