Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT00670150
Status:
WITHDRAWN
Last Update Posted:
2015-10-27
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
Sponsor:
University of Southern California
Organization:
Study Overview
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 Untreated Acute Promyelocytic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor withdrew support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: