New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00670150|
Recruitment Status : Withdrawn (sponsor withdrew support)
First Posted : May 1, 2008
Last Update Posted : October 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Promyelocytic Leukemia||Drug: NRX 195183 (retinoid analogue) Drug: Arsenic Trioxide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
- 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.
- The primary endpoint is achieving a partial or complete response [ Time Frame: Bone marrow biopsies will be done monthly during induction ]
- Safety and feasibility [ Time Frame: Twice weekly during induction and then weekly during consolidation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670150
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Dan Douer, MD||University of Southern California|