Clinical Trial: New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: 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 Un
Brief Summary: The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.
Detailed Summary:
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.
Sponsor: University of Southern California
Current Primary Outcome: The primary endpoint is achieving a partial or complete response [ Time Frame: Bone marrow biopsies will be done monthly during induction ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety and feasibility [ Time Frame: Twice weekly during induction and then weekly during consolidation ]
Original Secondary Outcome: Same as current
Information By: University of Southern California
Dates:
Date Received: April 28, 2008
Date Started: May 2010
Date Completion:
Last Updated: October 24, 2015
Last Verified: October 2015
