Acute Promyelocytic Leukemia Clinical Trial
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
The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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