NCT00670150

New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.

Detailed description

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.

Conditions

• Acute Promyelocytic Leukemia

Interventions

Type	Name	Description
DRUG	NRX 195183 (retinoid analogue)	30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation
DRUG	Arsenic Trioxide	0.15mg/kg/day over 2hrs VI on day 1-5 x 4 weeks. 2 weeks rest then repeat x 3 more cycles.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-05-01
• Last updated: 2015-10-27

Locations

1 site across 1 country: United States