Phase II Study of NRX 195183 Induction and NRX 195183 Combined With Arsenic Trioxide (As2o3) as Initial Consolidation Therapy Followed by Continuous NRX 195183 Maintenance Therapy for Patients With Untreated Acute Promyelocytic Leukemia
The primary objectives of this study are in newly diagnosed APL patients:
- To evaluate the efficacy (complete and molecular response rates) and toxicity of NRX
195183 in induction therapy
- To evaluate the efficacy (molecular response rates) and toxicity of NRX 195183 in
combination with arsenic trioxide (As2O3) in consolidation therapy.
- To evaluate the efficacy (event free-survival, disease-free survival) and toxicity of
NRX 195183 as maintenance therapy for patients with APL who achieve a molecular
complete response.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is achieving a partial or complete response
Bone marrow biopsies will be done monthly during induction
No
Dan Douer, MD
Principal Investigator
University of Southern California
United States: Institutional Review Board
9L-07-12
NCT00670150
May 2010
May 2011
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |