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Clinical Trial Summary

The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia


Clinical Trial Description

A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00675870
Study type Interventional
Source NuRx Pharmaceuticals, Inc.
Contact Nonna Snider, BS/BA
Phone 949-336-7111
Email nsnider@nurxpharma.com
Status Recruiting
Phase Phase 2
Start date April 2008

See also
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Suspended NCT04996030 - A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia Phase 1
Recruiting NCT02899169 - Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) Phase 3
Terminated NCT00852709 - Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias Phase 1
Recruiting NCT04793919 - Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia Phase 2
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Terminated NCT00985530 - Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia Phase 1
Withdrawn NCT00670150 - New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia Phase 2
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Active, not recruiting NCT03096496 - Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy
Completed NCT00465933 - Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA) Phase 4
Active, not recruiting NCT02688140 - Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia Phase 3
Active, not recruiting NCT01987297 - Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL Phase 4
Terminated NCT00907582 - ASCT for Relapsed APL After Molecular Remission Phase 2
Recruiting NCT00517712 - Single Agent Arsenic Trioxide in the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia Phase 2/Phase 3
Completed NCT01902329 - A Safety Study of SGN-CD33A in AML Patients Phase 1
Completed NCT01404949 - Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy Phase 2
Completed NCT00504764 - Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO) Phase 4