Clinical Trial: Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Brief Summary: The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia
Detailed Summary: 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.
Sponsor: NuRx Pharmaceuticals, Inc.
Current Primary Outcome: Complete Remission [ Time Frame: 90 Days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Molecular Complete Remission [ Time Frame: 9 months ]
Original Secondary Outcome: Same as current
Information By: NuRx Pharmaceuticals, Inc.
Dates:
Date Received: May 7, 2008
Date Started: April 2008
Date Completion:
Last Updated: May 9, 2008
Last Verified: May 2008